text: For the date of entry into force of this issue, kindly refer to Decision 2019/021/R in the Official Publication of the Agency. Page 1 of 130

text: TCAS traffic collision avoidance system TMPR tactical mitigation performance requirement UA unmanned aircraft UAS unmanned aircraft system UAS Regulation Commission Implementing

text: Regulation (EU) 2019/947 of 24 May 2019

text: on the rules and procedures for the operation of unmanned aircraft VLL very low level VLOS visual line of sight VO visual observer

text: STS# Edition/date UAS characteristics BVLOS/VLOS Overflown area Maximum range Maximum Airspace notes from remote height pilot

text: PDRA# Edition/date UAS characteristics BVLOS/VLOS Overflown area Maximum range Maximum Airspace AMC# to notes from remote height

text: Article 11

text: pilot

text: PDRA-01 1.0/xx.xx.2019 maximum characteristic dimension BVLOS sparsely If no VO up to 150 m Controlled AMC2

text: As defined by Article 4 of the UAS Regulation. 3 As defined by Article 6 of the UAS Regulation (EU).

text: Operation in control Loss of control of the operation (*) Abnormal situation Emergency situation Normal operation (undesired state) (unrecovered state) Standard / Contingency procedures Emergency procedures (return home, manual control, land on operationalpProcedures (land asap or activation of FTS, etc.) a pre-determined site etc.) Emergency response plan (plan to limit escalating effect of the loss of control of the operation) Operational Volume Area used to determine the intrinsic GRC Flight geography Contingency volume Risk buffer Adjacent areas

text: Area to which the operation needs to be technically contained Area to consider to determine the ARC Optional risk Flight geography Contingency volume Adjacent airspace buffer Area to which the operation needs to be technically contained

text: (*) The Loss of control of operation corresponds to situations:  where the outcome of the situation highly relies on providence; or  which could not be handled by a contingency procedure; or  when there is grave and imminent danger of fatalities.

text: Figure 1 — SORA semantic model

text: Figure 2 — Graphical representation of the SORA semantic model

text: Table 1 — Determination of robustness level

text: Step #1: ConOps description

text: As per Section 2.2.2 and Annexes A.1 and A.2

text: Step #2: Determination of the UAS intrinsic ground risk class (GRC)

text: As per Section 2.3.1

text: Step #3: Final GRC determination

text: As per Section 2.3.2 and Annex B

text: Is the GRC less than or equal to 7?

text: YES Step #4: Determination of the initial air risk cLass (ARC)

text: As per Section 2.4.2

text: Step #5 (optional): Application of strategic mitigations to determine the final ARC

text: As per Section 2.4.3 and Annex C

text: NO Step #6: TMPR and robustness levels

text: As per Section 2.4.4 and Annex D

text: Step # 7: SAIL determination

text: As per Section 2.5.1

text: Step #8: Identification of operational safety objectives (OSOs)

text: As per Section 2.5.2 and Annex E

text: Step #9: Adjacent area / airspace considerations

text: As per Section 2.5.3 and Annex E

text: Step#10: Comprehensive safety portfolio

text: Are the mitigations and objectives required by the SORA met with a sufficient level of confidence? As per Section 2.6

text: NO YES

text: Other process (e.g. UAS operation category certified ) approval (with or new application associated with a modified limitations) ConOps

text: Figure 3 — The SORA process

text: The flight technical error is the error between the actual track and the desired track (sometimes referred to as ‘the ability to fly the flight director’).

text: Intrinsic UAS ground risk class

text: m / approx. 3 m / approx. 8 m / approx. >8 m / approx. Max UAS characteristics dimension 3 ft 10 ft 25 ft 25 ft

text: < 700 J < 34 kJ < 1 084 kJ > 1 084 kJ

text: Typical kinetic energy expected (approx. (approx. (approx. (approx.

text: ft lb) 25 000 ft lb) 800 000 ft lb) 800 000 ft lb)

text: Operational scenarios

text: VLOS/BVLOS over a controlled 6 1 2 3 4 ground area VLOS in a sparsely populated 2 3 4 5 environment BVLOS in a sparsely populated 3 4 5 6 environment VLOS in a populated environment 4 5 6 8 7 7 7 7 BVLOS in a populated environment TBD TBD TBD TBD VLOS over an assembly of people 7 BVLOS over an assembly of people TBD

text: Table 2 — Determination of the intrinsic GRC

text: If the UA is planned to operate at 120 m altitude, the ground risk buffer should at least be 120 m. In line with Figure 1 and paragraph 2.3.1.(c), the controlled area should encompass the flight geography, the contingency volume and the ground risk buffer. The intrinsic ground risk class for BVLOS operations in populated environment or over gathering of people will be developed in a future edition of the SORA. EVLOS — A UAS operation whereby the remote pilot maintains uninterrupted situational awareness of the airspace in which the UAS operation is being conducted via visual airspace surveillance through one or more human VOs, possibly aided by technological means. The remote pilot has direct control of the UAS at all times.

text: Sequence Low/None Medium High M1 — Strategic mitigations for ground 0: None 1 -2 -4 risk -1: Low M2 — Effects of ground impact are 2 11 0 -1 -2 reduced M3 — An emergency response plan 3 (ERP) is in place, the UAS operator is 1 0 -1 validated and effective

text: Table 3 — Mitigations for final GRC determination

text: This mitigation is meant as a means to reduce the number of people at risk. 11 This mitigation is meant as a means to reduce the energy absorbed by the people on the ground upon impact.

text: Figure 4 — ARC assignment process

text: Residual ARC TMPRs TMPR level of robustness

text: ARC-d High High ARC-c Medium Medium ARC-b Low Low ARC-a No requirement No requirement

text: Table 4 — TMPRs and TMPR level of robustness assignment

text: Table 5 — SAIL determination

text: line with Annex E)

text: I II III IV V VI

text: OSO number (in

text: line with Annex E)

text: I II III IV V VI

text: The robustness level does not apply to mitigations for which credit has been taken to derive the risk classes. This is further detailed in para. 3.2.11(a).

text: OSO number (in

text: line with Annex E)

text: I II III IV V VI

text: Table 6 — Recommended OSOs

text: The term ‘probable’ needs to be understood in its qualitative interpretation, i.e. ‘Anticipated to occur one or more times during the entire system/operational life of an item.’ 14 The term ‘failure’ needs to be understood as an occurrence that affects the operation of a component, part, or element such that it can no longer function as intended. Errors may cause failures, but are not considered to be failures. Some structural or mechanical failures may be excluded from the criterion if it can be shown that these mechanical parts were designed according to aviation industry best practices.

text: Software (SW) and airborne electronic hardware (AEH) whose development error(s) could

text: directly (refer to Note 2) lead to operations outside the ground risk buffer should be developed

text: to an industry standard or methodology that is recognised as being adequate by the competent authority. As it is not possible to anticipate all local situations, the UAS operator, the competent authority and the ANSP should use sound judgement with regard to the definition of the ‘adjacent airspace’ as well as the ‘adjacent areas’. For example, for a small UAS with a limited range, these definitions are not intended to include busy airport/heliport environments 30 kilometres away. The airspace bordering the UAS volume of operation should be the starting point of the determination of the adjacent airspace. In exceptional cases, the airspace beyond those volumes that border the UAS volume of operation may also have to be considered. Note 1: The safety requirements as proposed in this section cover both the integrity and assurance levels. Note 2: The third safety requirement in Section 2.5.3(c) does not imply a systematic need to develop the SW and AEH according to an industry standard or methodology recognised as adequate by the competent authority. The use of the term ‘directly’ means that a development error in a software or an airborne electronic hardware would lead the UA outside the ground risk buffer without the possibility for another system to prevent the UA from exiting the operational volume. 2.6 Step #10 — comprehensive safety portfolio (a) The SORA process provides the applicant, the competent authority and the ANSP with a methodology which includes a series of mitigations and safety objectives to be considered to ensure an adequate level of confidence that the operation can be safely conducted. These are:

text: Table B.2 — Level of integrity assessment criteria for ground risk of non-tethered M1 mitigations

text: A UAS operating under VLOS may be able to comply with VFR. 17

text: Commission Regulation (EU) No 923/2012

text: laying down the common rules of the air and operational provisions regarding services and procedures in air navigation and amending Implementing

text: Regulation (EU) No 1035/2011

text: and Regulations

text: (EC) No 1265/2007

text: (EC) No 1794/2006

text: (EC) No 730/2006

text: (EC) No 1033/2006

text: and

text: (EU) No 255/2010

text: , OJ L 281, 13.10.2012, p.1.

text: Figure C.5 — SORA air-conflict mitigation process

text: The usage of the word ‘controlled’ means that the UAS operator is not reliant on the cooperation of other airspace users to implement an effective operational restriction mitigation strategy. 19 This usage of the word ‘structure’ means air structure, airways, traffic procedures and the like.

text: This usage of the word ‘structure’ means air structure, airways, traffic procedures and the like. 21 The usage of the words ‘does not control’ means that the UAS operator does not have control over the implementation of aviation structures and rules and is reliant on the competent authority to implement structures and rules.

text: The installation of an electronic cooperative system would make the UAS a cooperative aircraft in accordance with FAA Interim Operational Approval Guidance 08-01, ’Unmanned Aircraft Systems Operations in the U.S. National Airspace System,’ Federal Aviation Administration, FAA/AIR-160, 2008.

text: Operational environment, AEC and ARC Operations in: Initial generalised Corresponding AEC Initial ARC density rating Airport/heliport environment OPS in an airport/heliport AEC 1 environment in class B, C or D 5 ARC-d airspace OPS in an airport/heliport environment in class E 3 AEC 6 ARC-c airspace or in class F or G Operations above 400 ft AGL but below flight level 600 OPS > 400 ft AGL but < FL 600 in a Mode-S Veil or 5 AEC 2 ARC-d transponder mandatory zone (TMZ) OPS > 400 ft AGL but < FL 600 5 AEC 3 ARC-d in controlled airspace OPS > 400 ft AGL but < FL 600 in uncontrolled airspace over 3 AEC 4 ARC-c an urban area OPS > 400 ft AGL but < FL 600 in uncontrolled airspace over a 2 AEC 5 ARC-c rural area Operations below 400 ft AGL OPS < 400 ft AGL in a Mode-S 3 AEC 7 ARC-c Veil or TMZ OPS < 400 ft AGL in controlled 3 AEC 8 ARC-c airspace OPS < 400 ft AGL in uncontrolled airspace over an 2 AEC 9 ARC-c urban area OPS < 400 ft AGL in uncontrolled airspace over a 1 AEC 10 ARC-b rural area Operations above flight level 600 OPS > FL 600 1 AEC 11 ARC-b Operations in atypical or segregated airspace OPS in atypical/segregated 1 AEC 12 ARC-a airspace

text: The density rating of manned aircraft, assessed on a scale of 1 to 5, with 1 representing a very low density and 5 representing a very high density. Column A B C D Initial generalised If the local density can New lowered AEC density rating for Initial ARC be demonstrated to be (residual) ARC the environment similar to: AEC 1 or; 4 or 3 ARC-c 5 ARC-d Note 1 AEC 2 2 or 1 ARC-b AEC 3 3 or 2 ARC-c 4 ARC-d Note 1 1 ARC-b Note 1 AEC 4 3 ARC-c 1 ARC-b Note 1 AEC 5 2 ARC-c 1 ARC-b AEC 6 or; ARC-b Note 1 AEC 7 or; 3 ARC-c 1 AEC 8 Note 1 AEC 9 2 ARC-c 1 ARC-b Note 1: The reference environment for assessing density is AEC 10 (OPS < 400 ft AGL over rural areas). AEC10 and AEC 11 are not included in this table, as any ARC reduction would result in ARC-a. A UAS operator claiming a reduction to ARC-a should demonstrate that all the requirements that define atypical or segregated airspace have been met.

text: Table C.2

text: AEC 1, 2, 3, 4, and 5 already have manned airspace rules and structures defined by

text: Regulation (EU) No 923/2012

text: . Any UAS operating in these types of airspace shall comply with the applicable airspace rules, regulations and safety requirements. As such, no lowering of the ARC by common structures and rules is allowed, as those mitigations have already been accounted for in the assessment of those types of airspace. Lowering the ARC for rules and structures in AEC 1, 2, 3, 4, 5, and 11 would amount to double counting of the mitigations. 24 AEC 10: the initial ARC is ARC-b. To lower the ARC in these volumes of airspace (to ARC-a) requires the operational volume to meet one of the requirements of atypical/segregated Airspace.

text: Although the SORA takes into account the questionable effects of anti-collision lighting, it also takes into account that the installation of anti-collision lights is often relatively simple and has a net positive effect in preventing collisions. 26 Although NOTAMs are used here as an example, the use of NOTAMs may not be acceptable unless they cover all operations in VLL airspace. It is envisioned that a separate system like that of NOTAMs, which specifically addresses the concerns of VLL airspace, will fulfil this requirement. 27 Although flight plans and posting NOTAMS are used here as examples, the use of flight plans and NOTAMs may not be acceptable unless they cover all operations in VLL airspace. It is envisioned that a separate system, which specifically addresses the concerns of VLL airspace, will fulfil this requirement. 28 The U-space regulation and the relevant adaptation of SERA will apply 29 This refers to possible future applications of an automated traffic management separation service for unmanned aircraft in a U-space environment. These applications may not exist as such today. A subscription to these services may be required.

text: For the purposes of this dissection, systems like ATC separation services would be considered to be machine assisted.

text: Table D.1 — TMPR risk ration requirements table

text: TMPR Level

text: Function No Low Medium High VLOS Requirement (ARC-b) (ARC-c) (ARC-d) (ARC-a)

text: The expectation is for the applicant’s DAA Plan to

text: enable the operator to detect approximately 90 % ) 2 R The expectation is for the applicant’s DAA Plan to of all aircraft in the detection volume . To P M enable the operator to detect approximately 50 % accomplish this, the applicant will have to rely on (T 2 one or a combination of the following systems or s of all aircraft in the detection volume . ent This is the performance requirement in the services: A system

text: m • Ground based DAA /RADAR meeting RTCA re absence of failures and defaults. 3/6 SC-228 or It is required that the applicant has awareness of • FLARM equi 3/6 EUROCAE WGr ent ent most of the traffic operating in the area in which • Pilot Aware m m 6 105 1 re re the operator intends to fly, by relying on one or • ADS-B In/ UAT In Receiver ance MOPS/MASPS m Detect more of the following: 7 or equi equi • ATC Separation Services (or similar) rf R R • Use of (web-based) real time aircraft tracking 4 o o • UTM/U-space Surveillance Service and installed in pe N N services 3 • UTM/U-space Early Conflict Detection and accordance on • Use Low Cost ADS-B In /UAT/FLARM /Pilot 4 ti Resolution Service 3 with applicable iga Aware aircraft trackers • Active communication with ATC and other it 4 requirements. l m • Use of UTM/U-space Dynamic Geofencing 5 airspace users . ica • Monitoring aeronautical radio communications The operator provides an assessment of the ct 5 Ta (e.g. use of a scanner) effectiveness of the detection tools/methods

text: chosen.

text: For an in-depth understanding of the derivation, please see Annex G. Detection should be done with adequate precision for the avoidance manoeuvre to be effective.

text: The detection volume is the volume of airspace (temporal or spatial measurement) which is required to avoid a collision (and remain well clear if required) with manned

text: aircraft. It can be thought of as the last point at which a manned aircraft must be detected, so that the DAA system can performance all the DAA functions. The detection

text: volume in not tied to the sensor(s) Field of View/Field of Regard. The size of the detection volume depends on the aggravated closing speed of traffic that may reasonably

text: be encountered, the time required by the remote pilot to command the avoidance manoeuvre, the time required by the system to respond and the manoeuvrability and

text: performance of the aircraft. The detection volume is proportionally larger than the alerting threshold.

text: FLARM and PilotAware are commercially available (trademarked) products/brands. They are referenced here only as example technologies. The references do not imply

text: an endorsement by the approval authority for the use of these products. Other products offering similar functions may also be used.

text: These refer to possible future applications of automated traffic management systems for unmanned aircraft in an UTM/U-space environment. These applications may not

text: exist as such today.

text: If permitted by the authority. May require a Radio-License or Permit.

text: The selection of systems to aid in electronic detection of traffic should be made considering the average equipment of the majority of aircraft operating in the area. For

text: example: in areas where many gliders are known to operate, the use of FLARM or similar systems should be considered whereas for operations in the vicinity of large

text: commercially operated aircraft, ADS-B IN is probably more appropriate. These refer to possible future applications of automated traffic management systems for

text: unmanned aircraft in an UTM/U-space environment. These applications may not exist as such today. A subscription to these services may be required.

text: The selection of systems to aid in electronic detection of traffic should be made considering the average equipment of the majority of aircraft operating in the area.

text: TMPR Level

text: ) R All requirements of ARC-b and in addition: P M The UAS operator should have a documented de- (T 1. The operator provides an assessment of the s confliction scheme, in which the UAS operator human/machine interface factors that may affect ent explains which tools or methods will be used for A system the remote pilot’s ability to make a timely and m detection and what the criteria are that will be meeting RTCA re appropriate decision. applied for the decision to avoid incoming traffic. SC-228 or equi 2. The UAS operator provides an assessment of r ent ent In case the remote pilot relies on detection by EUROCAE WGm m the effectiveness of the tools and methods someone else, the use of phraseology will have to 105 ance re re utilised for the timely detection and avoidance of m Decide be described as well. MOPS/MASPS equi equi traffic. or R R Examples: (or similar) rf o o In this context timely is defined as enabling the pe N N • The operator will initiate a rapid descend if and installed in remote pilot to decide within 5 seconds after the on traffic is crossing an alert boundary and operating accordance ti indication of incoming traffic is provided. at less than 1000ft. with applicable iga The UAS operator provides an assessment of the it • The observer monitoring traffic uses the phrase: requirements. l m failure rate or availability of any tool or service ‘DESCEND!, DESCEND!, DESCEND!’. ica the UAS operator intends to use. ct Ta

text: TMPR Level

text: No Function Low Medium High VLOS Requirement (ARC-b) (ARC-c) (ARC-d) (ARC-a)

text: ) R P M (T s ent A system

text: m meeting RTCA re SC-228 or

text: equi The latency of the whole command (C2) link, i.e. The latency of the whole command (C2) link, i.e. EUROCAE WGr ent ent m m the time between the moment that the remote the time between the moment that the remote 105 ance re re m Command pilot gives the command and the airplane pilot gives the command and the airplane MOPS/MASPS or equi equi executes the command should not exceed 5 executes the command should not exceed 3 (or similar) R R rf o o pe N N seconds. seconds. and installed in

text: on accordance ti with applicable iga it requirements.

text: ica ct Ta

text: TMPR Level

text: ) R P M (T s Avoidance may rely on vertical and horizontal ent A system avoidance manoeuvring and is defined in m meeting RTCA re UAS descending to an altitude not higher than the standard procedures. Where horizontal SC-228 or nearest trees, buildings or infrastructure or ≤ 60 manoeuvring is applied, the aircraft shall be equi EUROCAE WGr ent ent feet AGL is considered sufficient. demonstrated to have adequate performance, m m 105 ance re re The aircraft should be able to descend from its such as airspeed, acceleration rates, m Execute MOPS/MASPS operating altitude to the ‘safe altitude’ in less than climb/descend rates and turn rates. The following or equi equi 10 (or similar) rf R R a minute. o o are suggested minimum performance criteria: pe N N and installed in • Airspeed: ≥ 50 knots on accordance ti • Rate of climb/descend: ≥ 500 ft/min with applicable iga • Turn rate: ≥ 3 degrees per second it requirements.

text: l m ica ct Ta

text: Low End Performance Representative (LEPR) performance requirments for RTCA SC-228 Study 5

text: TMPR Level

text: ) R P M The information is provided to the remote pilot (T s with a latency and update rate that support the A system

text: ent decision criteria. The applicant provides an meeting RTCA m Where electronic means assist the remote pilot in re assessment of the aggravated closure rates SC-228 or detecting traffic, the information is provided with equi considering traffic that could reasonably be EUROCAE WGr ent ent a latency and update rate for intruder data (e.g. m m expected to operate in the area, traffic 105 position, speed, altitude, track) that support the ance Feedback re re information update rate and latency, C2 Link MOPS/MASPS m decision criteria. Loop equi equi latency, aircraft manoeuvrability and (or similar) or R R For an assumed 3 NM threshold, a 5 second rf o o performance and sets the detection thresholds and installed in pe N N update rate and a latency of 10 seconds is accordingly. accordance on considered adequate (see example below). ti The following are suggested minimum criteria: with applicable

text: iga • Intruder and ownship vector data update rates: airworthiness it ≤ 3 seconds. requirements. l m ica ct Ta

text: Table D.2 — TMPR qualitative criteria table

text: TMPR: N/A TMPR: Low TMPR: Medium TMPR: High (ARC-a) (ARC-b) (ARC-c) (ARC-d)

text: Allowable loss of Allowable loss of Allowable loss of Allowable loss of function and function and function and function and performance of the performance of the performance of the performance of the Criteria Tactical Mitigation Tactical Mitigation Tactical Mitigation Tactical Mitigation System: < 1 per 100 System: < 1 per 100 System: < 1 per 1 000 System: < 1 per 100 000 Flight Hours Flight Hours Flight Hours Flight Hours (1E-2 Loss/FH) (1E-2 Loss/FH) (1E-3 Loss/FH) (1E-5 Loss/FH)

text: Level of This rate is integrity commensurate with

text: The requirement is The requirement is a probable failure considered to be met considered to be met condition. These

text: Comments / by commercially by commercially failure conditions are A quantitative analysis is Notes available products. available products. anticipated to occur required.

text: No quantitative No quantitative one or more times

text: analysis is required. analysis is required. during the entire

text: operational life of

text: each aircraft.

text: The operator The operator The evidence that the declares that the provides evidence tactical mitigation tactical mitigation that the tactical system will mitigate the system and mitigation system risk of collisions with Criteria N/A procedures will will mitigate the risk manned aircraft to an mitigate the risk of of collisions with acceptable level is Level of collisions with manned aircraft to an verified by a competent assurance manned aircraft to an acceptable level. third party. acceptable level.

text: Comments / N/A N/A N/A N/A Notes

text: Table D.3 — TMPR integrity and assurance objectives

text: Principle description Additional information

text: #1 Annex E provides assessment criteria for the The identification of OSOs for a given operation is the integrity (i.e. safety gain) and assurance (i.e. responsibility of the applicant. method of proof) of OSOs proposed by an applicant. #2 Annex E does not cover the LoI of the competent authority. Lol is based on the competent authority’s assessment of the applicant’s ability to perform the given operation. #3 To achieve a given level of integrity/assurance, when more than one criterion exists for that level of integrity/assurance, all applicable criteria need to be met. #4 ‘Optional’ cases defined in SORA main body Table All robustness levels are acceptable for OSOs for which an 6 do not need to be defined in terms of integrity ‘optional’ level of robustness is defined in Table 6 and assurance levels in Annex E. ‘Recommended OSOs’ of the SORA main body. #5 When the criteria to assess the level of integrity or assurance of an OSO rely on ‘standards’ that are not yet available, the OSO needs to be developed in a manner acceptable to the competent authority. #6 Annex E intentionally uses non-prescriptive terms (e.g. suitable, reasonably practicable) to provide flexibility to both the applicant and the competent authorities. This does not constrain the applicant in proposing mitigations, nor the competent authority in evaluating what is needed on a caseby-case basis. #7 This annex in its entirety also applies to single-person organisations.

text: Table E.1 – Basic principles to consider when using SORA Annex E

text: Level of integrity TECHNICAL ISSUE WITH THE UAS Low Medium High

text: Same as low. In addition, the applicant has The applicant is knowledgeable of the UAS an organisation appropriate for the being used and as a minimum has the intended operation. Also, the applicant has

text: OSO #01

text: Criteria following relevant operational procedures: a method to identify, assess, and mitigate Same as medium.

text: Ensure that

text: checklists, maintenance, training, the risks associated with flight operations.

text: the UAS

text: responsibilities, and associated duties. These should be consistent with the nature

text: operator is

text: and extent of the operations specified.

text: and/or For the purpose of this assessment, proven ‘appropriate’ should be interpreted as

text: Comments N/A commensurate with/proportionate to the N/A size of the organisation and the complexity

text: of the operation.

text: Level of assurance TECHNICAL ISSUE WITH THE UAS Low Medium High

text: The applicant holds an organisational

text: operating certificate or has a recognised

text: OSO #01

text: Prior to the first operation, a competent flight test organisation. Ensure that the The elements delineated in the level of Criteria third party performs an audit of the UAS operator is integrity are addressed in the ConOps. In addition, a competent third party organisation

text: recurrently verifies the UAS operator’s

text: and/or proven

text: competences.

text: Comments N/A N/A N/A

text: TECHNICAL ISSUE WITH THE UAS Level of integrity

text: Low Medium High

text: Same as low. In addition, manufacturing

text: procedures also cover:

text: As a minimum, manufacturing procedures (a) configuration control; cover: Same as medium. In addition, the (b) the verification of incoming products, (a) the specification of materials; manufacturing procedures cover at least: OSO #02 parts, materials, and equipment;

text: UAS (b) the suitability and durability of (a) manufacturing processes; (c) identification and traceability; manufactured Criteria materials used; and (b) personnel competence and by competent (d) in-process and final inspections & (c) the processes necessary to allow for qualifications; and and/or proven testing; repeatability in manufacturing, and entity (c) supplier control. conformity within acceptable (e) the control and calibration of tools;

text: tolerances. (f) handling and storage; and

text: (g) the control of non-conforming items.

text: Comments N/A N/A N/A

text: Same as medium. In addition:

text: (a) manufacturing procedures; and The declared manufacturing procedures OSO #02 Same as low. In addition, evidence is are developed to a standard considered (b) the conformity of the UAS to its design UAS available that the UAS has been Criteria adequate by the competent authority manufactured in conformance to its and specification

text: and/or in accordance with a means of by competent design. are recurrently verified through process or compliance acceptable to that authority. and/or proven product audits by a competent third party

text: entity (or competent third parties).

text: Comments N/A N/A N/A

text: Same as low. In addition: (a) The UAS maintenance instructions are (a) Scheduled maintenance of each UAS is defined, and, when applicable, cover organised and in accordance with a Same as medium. In addition, the the UAS designer’s instructions and maintenance programme. maintenance staff work in accordance with OSO #03 requirements. a maintenance procedure manual that UAS (b) Upon completion, the maintenance log (b) The maintenance staff is competent and provides information and procedures maintained by Criteria system is used to record all the has received an authorisation to carry relevant to the maintenance facility, competent maintenance conducted on the UAS, out UAS maintenance. records, maintenance instructions, release, and/or including releases. A maintenance tools, material, components, defect proven entity (c) The maintenance staff use the UAS release can only be accomplished by a deferral, etc. (e.g. industry maintenance instructions while staff member who has received a standards) performing maintenance. maintenance release authorisation for

text: that particular UAS model/family.

text: Comments N/A N/A N/A

text: Same as low. In addition: (a) The maintenance instructions are OSO #03 (a) The maintenance programme is documented. UAS developed in accordance with (b) The maintenance conducted on the UAS maintained by standards considered adequate by the Same as medium. In addition, the is recorded in a maintenance log competent Criterion #1 competent authority and/or in maintenance programme and the

text: and/or (Procedure) system . accordance with a means of compliance maintenance procedures manual are

text: proven entity (c) A list of the maintenance staff acceptable to that authority. validated by a competent third party. (e.g. industry authorised to carry out maintenance is (b) A list of maintenance staff with

text: established and kept up to date. maintenance release authorisation is

text: established and kept up to date.

text: Objective is to record all the maintenance performed on the aircraft, and why it is performed (rectification of defects or malfunctions, modifications, scheduled Comments N/A N/A maintenance, etc.) The maintenance log may be requested for inspection/audit by the approving

text: authority or an authorised representative. Same as low. In addition:

text: (a) The initial training syllabus and training standard including theoretical/practical elements, duration, etc. is defined and Same as medium. In addition: is commensurate with the authorisation A record of all the relevant qualifications, (a) A programme for the recurrent training held by the maintenance staff. of staff holding a maintenance release Criterion #2 experience and/or training completed by (Training) the maintenance staff is established and (b) For staff that hold a maintenance authorisation is established; and kept up to date. release authorisation, the initial training (b) This programme is validated by a is specific to that particular UAS competent third party. model/family. (c) All maintenance staff have undergone initial training.

text: Comments N/A N/A N/A

text: The UAS is designed to standards The UAS is designed to standards The UAS is designed to standards

text: considered adequate by the competent considered adequate by the competent considered adequate by the competent

text: OSO #04

text: authority and/or in accordance with a authority and/or in accordance with a authority and/or in accordance with a

text: means of compliance acceptable to that means of compliance acceptable to that means of compliance acceptable to that developed to Criteria authority. The standards and/or the means authority. The standards and/or the means authority. The standards and/or the means

text: of compliance should be applicable to a low of compliance should be applicable to a of compliance should be applicable to a

text: level of integrity and the intended medium level of integrity and the intended high level of integrity and the intended

text: operation. operation. operation.

text: Comments NAAs may define the standards and/or the means of compliance they consider adequate.

text: Level of assurance TECHNICAL ISSUE WITH THE UAS Low Medium High OSO #04

text: Criteria Consider the criteria defined in Section 9

text: UAS developed to authority recognised

text: Comments N/A N/A N/A

text: design standards

text: Same as medium. In addition: (a) Major failure conditions are not more frequent than remote ;

text: (b) Hazardous failure conditions are not more frequent than extremely remote ; (c) Catastrophic failure conditions are not Same as low. In addition, the strategy for The equipment, systems, and installations more frequent than extremely detection, alerting and management of any 3 1 improbable ; and are designed to minimise hazards in the Criteria malfunction, failure or combination event of a probable malfunction or failure (d) SW and AEH whose development

text: OSO #05

text: thereof, which would lead to a hazard, is UAS is of the UAS. error(s) may cause or contribute to available. designed hazardous or catastrophic failure considering conditions are developed to an industry system safety standard or a methodology considered and reliability adequate by the competent authority and/or in accordance with means of compliance acceptable to that authority . 1 3 For the purpose of this assessment, the Safety objectives may be derived from term ‘hazard’ should be interpreted as a JARUS AMC RPAS.1309 Issue 2 Table 3 failure condition that relates to major, depending on the kinetic energy assessment

text: Comments N/A

text: hazardous, or catastrophic consequences. made in accordance with Section 6 of EASA 2 policy E.Y013-01.

text: For the purpose of this assessment, the

text: term ‘probable’ should be interpreted in a 4

text: Development assurance levels (DALs) for

text: qualitative way as ‘anticipated to occur one SW/AEH may be derived from JARUS AMC or more times during the entire RPAS.1309 Issue 2 Table 3 depending on the

text: kinetic energy assessment made in

text: system/operational life of a UAS’.

text: accordance with Section 6 of EASA policy

text: Same as low. In addition: (a) Safety analyses are conducted in line 1 with standards considered adequate by A functional hazard assessment and a Same as medium. In addition, safety the competent authority and/or in design and installation appraisal that analyses and development assurance OSO #05 Criteria accordance with a means of compliance activities are validated by EASA, according to shows hazards are minimised, are acceptable to that authority. UAS is

text: Article 40 of Regulation (EU) 2019/945

text: . available. designed (b) A strategy for the detection of single considering failures of concern includes pre-flight checks.

text: system safety

text: and reliability The severity of failure conditions (no

text: safety effect, minor, major, hazardous and Comments catastrophic) should be determined N/A N/A

text: according to the definitions provided in

text: JARUS AMC RPAS.1309 Issue 2.

text: (a) The applicant determines that the

text: performance, RF spectrum usage and environmental conditions for C3 links are adequate to safely conduct the intended operation. Same as low. In addition, the use of 3 4 Same as low . licensed frequency bands for C2 Links is Criteria (b) The remote pilot has the means to required. continuously monitor the C3

text: performance and ensures that the performance continues to meet the operational requirements .

text: For a low level of integrity, unlicensed

text: OSO #06

text: frequency bands might be acceptable under

text: C3 link

text: certain conditions, e.g.:

text: (a) the applicant demonstrates compliance

text: (e.g.

text: with other RF spectrum usage

text: requirements (e.g. Directive

text: spectrum use) 4

text: ), by showing that the UAS This ensures a minimum level of

text: performance and is not limited to equipment is compliant with these

text: appropriate 3 Depending on the operation, the use of aeronautical licensed frequency bands (e.g.

text: requirements; and

text: for the licensed frequency bands might be licensed bands for cellular network). operation (b) the use of mechanisms to protect necessary. In some cases, the use of Nevertheless, some operations may require Comments against interference (e.g. FHSS, non-aeronautical bands (e.g. licensed the use of bands allocated to the frequency de-confliction by procedure). bands for cellular network) may be

text: aeronautical mobile service for the use of

text: acceptable. C2 Link (e.g. 5030 – 5091 MHz).

text: The remote pilot has continual and timely

text: access to the relevant C3 information that In any case, the use of licensed frequency

text: could affect the safety of flight. For bands needs authorisation.

text: operations requesting only a low level of integrity for this OSO, this could be achieved by monitoring the C2 link signal strength and receiving an alert from the UAS HMI if

text: the signal strength becomes too low.

text: OSO #06 Demonstration of the C3 link performance C3 link is in accordance with standards Consider the assurance criteria defined in considered adequate by the competent Same as medium. In addition, evidence is

text: validated by a competent third party. Section 9 (low level of assurance) authority and/or in accordance with

text: (e.g.

text: means of compliance acceptable to that

text: authority.

text: spectrum use) are appropriate

text: Comments N/A N/A N/A

text: for the operation

text: Level of integrity TECHNICAL ISSUE WITH THE UAS Low Medium High OSO #07 Inspection of

text: Criteria The remote crew ensures that the UAS is in a condition for safe operation and conforms to the approved ConOps.

text: the UAS (product inspection) to ensure

text: The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see consistency Comments the table below).

text: with the ConOps

text: Product inspection is documented and Same as medium. In addition, the product Criterion #1 Same as low. In addition, the product accounts for the manufacturer’s inspection is validated by a competent OSO #07 (Procedures) inspection is documented using checklists. recommendations if available. third party.

text: Inspection of

text: the UAS Comments N/A N/A N/A

text: inspection) to (a) A training syllabus including a product A competent third party: ensure The remote crew is trained to perform the inspection procedure is available. Criterion #2 consistency product inspection, and that training is self- (a) validates the training syllabus; and (b) The UAS operator provides

text: with the declared (with evidence available). competency-based, theoretical and (b) verifies the remote crew competencies.

text: practical training.

text: Comments N/A N/A N/A

text: Level of integrity OPERATIONAL PROCEDURES Low Medium High

text: (a) Operational procedures appropriate for the proposed operation are defined and, as a minimum, cover the following elements: (1) Flight planning; (2) Pre- and post-flight inspections; (3) Procedures to evaluate the environmental conditions before and during the mission (i.e. real-time evaluation); (4) Procedures to cope with unexpected adverse operating conditions (e.g. when ice is encountered during an operation not Criterion #1 approved for icing conditions); (Procedure (5) Normal procedures; definition) (6) Contingency procedures (to cope with abnormal situations); (7) Emergency procedures (to cope with emergency situations); (8) Occurrence reporting procedures; and OSO #08, OSO Note: normal, contingency and emergency procedures are compiled in an OM. #11, OSO #14 2 (b) The limitations of the external systems supporting UAS operation are defined in an OM.

text: and OSO #21

text: Operational procedures cover the deterioration of the UAS itself and any external system supporting UAS operation.

text: In the scope of this assessment, external systems supporting UAS operation are defined as systems that are not already part of the UAS but are used to: (a) launch/take-off the UA;

text: (b) make pre-flight checks; or Comments

text: (c) keep the UA within its operational volume (e.g. GNSS, satellite systems, air traffic management, U-Space). External systems activated/used after a loss of control of the operation are excluded from this definition.

text: To properly address the deterioration of external systems required for the operation, it is recommended to: (a) identify these ‘external systems’;

text: (b) identify the modes of deterioration of the ‘external systems’ (e.g. complete loss of GNSS, drift of the GNSS, latency issues, etc.) which would lead to a loss of control of the operation;

text: (c) describe the means to detect these modes of deterioration of the external systems/facilities; and (d) describe the procedure(s) used when deterioration is detected (e.g. activation of the emergency recovery capability, switch to manual control, etc.).

text: Operational procedures are complex and Contingency/emergency procedures Criterion #2 may potentially jeopardise the crew’s require manual control by the remote (Procedure ability to respond by raising the remote 2 Operational procedures are simple. pilot when the UAS is usually complexity) crew’s workload and/or the interactions automatically controlled. with other entities (e.g. ATM, etc.).

text: This is still under discussion since not all UAS have a mode where the pilot could Comments N/A directly control the surfaces; moreover, N/A some people claim it requires significant

text: skill not to make things worse.

text: At a minimum, operational procedures provide: Criterion #3 (a) a clear distribution and assignment of Same as medium. In addition, the remote (Consideration of Operational procedures take human error 3 tasks, and crew receives crew resource management Potential Human into consideration. 4 (CRM) training. Error) (b) an internal checklist to ensure staff are adequately performing their assigned tasks.

text: In the context of the SORA, the term ‘remote crew’ refers to any person

text: involved in the mission.

text: Comments N/A N/A CRM training focuses on the effective use of all the remote crew to ensure safe and

text: efficient operation, reducing error, avoiding stress and increasing efficiency.

text: Level of assurance OPERATIONAL PROCEDURES Low Medium High

text: (a) Operational procedures are validated against standards considered adequate by the competent authority and/or in Same as medium. In addition: (a) Operational procedures do not require accordance with a means of validation against either a standard or a (a) Flight tests performed to validate the compliance acceptable to that procedures and checklists cover the means of compliance considered authority. adequate by the competent authority. complete flight envelope or are proven (b) Adequacy of the contingency and OSO #08, OSO Criteria to be conservative. (b) The adequacy of the operational emergency procedures is proven

text: #11, OSO #14

text: (b) The procedures, checklists, flight tests procedures is declared, except for through: and OSO #21 and simulations are validated by a emergency procedures, which are tested. (1) dedicated flight tests; or competent third party.

text: (2) simulation, provided the simulation is proven valid for the intended purpose with positive results.

text: Comments N/A N/A

text: Level of integrity REMOTE CREW COMPETENCIES Low Medium High

text: The competency-based, theoretical and practical training is adequate for the operation and ensures knowledge of: (a) the UAS Regulation; (b)airspace operating principles; (c) airmanship and aviation safety; Criteria (d)human performance limitations;

text: OSO #09, OSO

text: #15 and OSO #22 (e) meteorology; (f) navigation/charts; (g) the UAS; and (h)operating procedures. The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see

text: table below).

text: Level of assurance REMOTE CREW COMPETENCIES Low Medium High

text: Training is self-declared (with evidence Criteria (a) Training syllabus is available. A competent third party: available).

text: (b) The UAS operator provides (a) validates the training syllabus; and competency-based, theoretical and OSO #09, OSO (b) verifies the remote crew practical training. #15 and OSO #22 competencies.

text: Comments N/A N/A N/A

text: LEVEL of INTEGRITY Low Medium High

text: When operating over populated areas or When operating over populated areas or assemblies of people, it can be reasonably expected assemblies of people, it 3 that a fatality will not occur from any single failure of the UAS or any external system can be reasonably supporting the operation. expected that a fatality Same as Criteria SW and AEH whose development error(s) could directly lead to a failure affecting the will not occur from any medium 1 2 operation in such a way that it can be reasonably expected that a fatality will occur, are probable failure of the UAS or any external developed to a standard considered adequate by the competent authority and/or in system supporting the accordance with means of compliance acceptable to that authority.

text: OSO #10

text: operation.

text: & OSO #12

text: For the purpose of this assessment, the term

text: ‘probable’ should be Some structural or mechanical failures may be excluded from the no-single failure criterion interpreted in a if it can be shown that these mechanical parts were designed to a standard considered

text: qualitative way as, adequate by the competent authority and/or in accordance with a means of compliance

text: ‘anticipated to occur one acceptable to that authority or more times during the entire

text: system/operational life

text: of a UAS’.

text: Some structural or mechanical failures may be excluded from the criterion if it can be shown that these mechanical parts were designed according to aviation industry best

text: practices.

text: LEVEL of ASSURANCE Low Medium High

text: A design and installation appraisal is available. In particular, this appraisal shows that: (a) the design and installation features Same as low. In addition, the level of (independence, separation and Same as medium. In addition, a competent integrity claimed is substantiated by OSO #10 Criteria redundancy) satisfy the low integrity third party validates the level of integrity analysis and/or test data with supporting & OSO #12 criterion; and claimed. evidence. (b) particular risks relevant to the ConOps (e.g. hail, ice, snow, electromagnetic interference, etc.) do not violate the independence claims, if any.

text: Comments N/A N/A N/A

text: DETERIORATION OF EXTERNAL Level of integrity SYSTEMS SUPPORTING UAS OPERATIONS BEYOND THE Low Medium High CONTROL OF THE UAS

text: The applicant ensures that the level of performance for any externally provided service necessary for the safety of the flight is adequate for the intended operation.

text: OSO #13

text: External Criteria If the externally provided service requires communication between the UAS operator and the service provider, the applicant ensures

text: there is effective communication to support the service provision.

text: Roles and responsibilities between the applicant and the external service provider are defined.

text: UAS operations

text: Requirements for contracting services with

text: are adequate

text: the service provider may be derived from

text: for the Comments N/A N/A ICAO Standards and Recommended

text: Practices (SARPs) that are currently under

text: development.

text: DETERIORATION OF EXTERNAL Level of assurance SYSTEMS SUPPORTING UAS OPERATION BEYOND THE CONTROL Low Medium High OF THE UAS

text: The applicant has supporting evidence Same as medium. In addition:

text: OSO #13

text: The applicant declares that the requested that the required level of performance for External services (a) the evidence of the performance of an level of performance for any externally any externally provided service required supporting UAS externally provided service is achieved Criteria provided service necessary for the safety of for safety of the flight can be achieved for operations are through demonstrations; and the flight is achieved (without evidence the full duration of the mission. adequate for the being necessarily available). (b) a competent third party validates the This may take the form of a service-level operation claimed level of integrity. agreement (SLA) or any official

text: commitment that prevails between a service provider and the applicant on the relevant aspects of the service (including quality, availability, responsibilities). The applicant has a means to monitor externally provided services which affect flight critical systems and take appropriate actions if real-time performance could lead to the loss of control of the operation.

text: Comments N/A N/A N/A

text: Level of integrity HUMAN ERROR Low Medium High

text: Procedure(s) to ensure coordination between the crew members and robust and effective communication channels is (are) available and at a minimum cover: Criterion #1 (Procedures) (a) assignment of tasks to the crew, and (b) establishment of step-by-step communications.

text: The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see

text: the table below). Criterion #2 Remote crew training covers multi-crew Same as low. In addition, the remote crew 3 Same as medium. (Training) coordination receives CRM training.

text: In the context of the SORA, the term

text: OSO #16 Multi ‘remote crew’ refers to any person involved crew in the mission.

text: Comments N/A 3 N/A CRM training focuses on the effective use of all the remote crew to assure a safe and efficient operation, reducing error, avoiding

text: stress and increasing efficiency. Communication devices comply with Communication devices are redundant Criterion #3 standards considered adequate by the and comply with standards considered (Communication N/A competent authority and/or in accordance adequate by the competent authority devices) with a means of compliance acceptable to and/or in accordance with a means of that authority. compliance acceptable to that authority.

text: N/A This implies the provision of an extra device Comments N/A

text: to cope with the failure of the first device.

text: LEVEL of ASSURANCE HUMAN ERROR Low Medium High

text: (a) Procedures are validated against standards considered adequate by the Same as medium. In addition: competent authority and/or in (a) Procedures do not require validation accordance with means of compliance against either a standard or a means of (a) flight tests performed to validate the compliance considered adequate by acceptable to that authority. procedures cover the complete flight

text: the competent authority. envelope or are proven to be Criterion #1 (b) Adequacy of the procedures is proven (Procedures) through: conservative; and (b) The adequacy of the procedures and checklists is declared. (b) the procedures, flight tests and (1) dedicated flight tests; or simulations are validated by a (2) simulation, provided the simulation competent third party. is proven valid for the intended

text: OSO #16 Multi

text: purpose with positive results.

text: coordination Comments N/A N/A N/A

text: (a) Training syllabus is available. A competent third party:

text: (a) validates the training syllabus; and Criterion #2 Training is self-declared (with evidence (b) The UAS operator provides (Training) available) competency-based, theoretical and (b) verifies the remote crew practical training. competencies.

text: Comments N/A N/A N/A

text: Criterion #3 (Communication Consider the criteria defined in Section 9

text: devices) Comments N/A N/A N/A

text: Same as low. In addition: — Duty, flight duty and resting times for Same as Medium. In addition: the remote crew are defined by the The applicant has a policy defining how the — The remote crew is medically fit, OSO #17 applicant and adequate for the Criteria remote crew can declare themselves fit to — A fatigue risk management system Remote crew is operation. operate before conducting any operation. (FRMS) is in place to manage any fit to operate — The UAS operator defines escalation in duty/flight duty times. requirements appropriate for the remote crew to operate the UAS.

text: Comments N/A N/A N/A

text: Same as Low. In addition: Same as Medium. In addition: OSO #17  The policy to define how the remote crew — Medical standards considered — Remote crew duty, flight duty and the Remote crew is Criteria declares themselves fit to operate (before adequate by the competent authority resting times policy are documented. fit to operate an operation) is documented. and/or means of compliance — Remote crew duty cycles are logged acceptable to that authority are and cover at a minimum:

text:  The remote crew declaration of fit to — when the remote crew member’s established and a competent third operate (before an operation) is based on duty day commences, party verifies that the remote crew is policy defined by the applicant. — when the remote crew members medically fit. are free from duties, and — A competent third party validates the — resting times within the duty duty/flight duty times. cycle. — If an FRMS is used, it is validated and — There is evidence that the remote monitored by a competent third crew is fit to operate the UAS. party.

text: Comments N/A N/A N/A

text: LEVEL of INTEGRITY HUMAN ERROR Low Medium High

text: The UAS flight control system incorporates automatic protection of the flight envelope OSO #18 to prevent the remote pilot from making The UAS flight control system incorporates automatic protection of the flight envelope to

text: Criteria any single input under normal operating ensure the UA remains within the flight envelope or ensures a timely recovery to the protection of the 1 conditions that would cause the UA to designed operational flight envelope following remote pilot error(s).

text: flight envelope

text: exceed its flight envelope or prevent it

text: from human

text: from recovering in a timely fashion.

text: The distinction between a medium and a high level of robustness for this criterion is

text: Comments N/A

text: achieved through the level of assurance (see table below).

text: The automatic protection of the flight

text: OSO #18

text: The automatic protection of the flight Automatic envelope has been developed to standards Same as Medium. In addition, evidence is Criteria envelope has been developed in-house or protection of considered adequate by the competent validated by EASA. out of the box (e.g. using commercial the flight authority and/or in accordance with a

text: envelope from off-the-shelf elements), without following means of compliance acceptable to that human errors specific standards. authority.

text: Comments N/A N/A N/A

text: Procedures and checklists that mitigate the risk of potential human errors from any person involved with the mission are defined Criterion #1 and used. (Procedures and Procedures provide at a minimum: checklists) — a clear distribution and assignment of tasks, and

text: OSO #19

text: — an internal checklist to ensure staff are adequately performing their assigned tasks.

text: Safe recovery

text: from Human N/A

text: Comments N/A N/A

text: Criterion #2 — The remote crew is trained to use procedures and checklists. 1 2 3 (Training) — The remote crew receives CRM training. In the context of SORA, the term ‘remote crew’ refers to any person involved in the mission. Comments CRM training focuses on the effective use of all the remote crew to ensure a safe and efficient operation, reducing error, avoiding stress and increasing efficiency.

text: The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see table below). Systems detecting and/or recovering from human errors are developed to standards Systems detecting and/or recovering from Criterion #3 considered adequate by the competent human errors are developed according to Same as medium. (UAS design) authority and/or in accordance with a industry best practices. means of compliance acceptable to that authority.

text: Comments N/A N/A N/A

text: — Procedures and checklists are validated against standards considered adequate by the — Procedures and checklists do not competent authority and/or in Same as Medium. In addition: require validation against either a accordance with a means of standard or a means of compliance compliance acceptable to that — Flight tests performed to validate the Criterion #1 considered adequate by the authority. procedures and checklists cover the (Procedures and competent authority. complete flight envelope or are checklists) — The adequacy of the procedures and — Adequacy of the procedures and proven to be conservative. OSO #19 checklists is proven through: — checklists is declared. The procedures, checklists, flight tests Safe recovery — Dedicated flight tests, or and simulations are validated by a from Human — competent third party. Simulation, provided the

text: simulation is proven valid for the intended purpose with positive results.

text: Comments N/A N/A N/A

text: Criterion #2 Consider the criteria defined for the level of assurance of the generic remote crew training OSO (i.e. OSO #09, OSO #15 and OSO #22) (Training) corresponding to the SAIL of the operation

text: Comments N/A N/A N/A

text: Criterion #3

text: Consider the criteria defined in Section 9 (UAS design)

text: Comments N/A N/A N/A

text: The UAS information and control interfaces are clearly and succinctly presented and do not confuse, cause unreasonable fatigue, or OSO #20 Criteria contribute to remote crew errors that could adversely affect the safety of the operation.

text: A Human Factors If an electronic means is used to support potential VOs in their role to maintain awareness of the position of the unmanned aircraft, its

text: evaluation has HMI: been performed — is sufficient to allow the VOs to determine the position of the UA during operation; and and the HMI Comments — does not degrade the VO’s ability to:

text: — scan the airspace visually where the unmanned aircraft is operating for any potential collision hazard; and

text: appropriate for

text: — maintain effective communication with the remote pilot at all times.

text: the mission

text: OSO #20 The applicant conducts a human factors Same as Medium. In addition, EASA A Human Factors evaluation of the UAS to determine witnesses the HMI evaluation of the UAS Same as Low but the HMI evaluation is evaluation has Criteria whether the HMI is appropriate for the 1 and a competent third party witnesses based on demonstrations or simulations. mission. The HMI evaluation is based on the HMI evaluation of the possible

text: been performed

text: inspection or analyses. electronic means used by the VO.

text: and the HMI

text: found When simulation is used, the validity of

text: Comments N/A the targeted environment used in the N/A

text: appropriate for

text: simulation needs to be justified.

text: the mission

text: LEVEL of INTEGRITY ADVERSE OPERATING CONDITIONS Low Medium High

text: Criterion #1 1 The environmental conditions for safe operations are defined and reflected in the flight manual or equivalent document. (Definition)

text: OSO #23 1 The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see Environmental Comments table below).

text: conditions for

text: Criterion #2 Procedures to evaluate environmental conditions before and during the mission (i.e. real-time evaluation) are available and include safe operations 2 (Procedures) assessment of meteorological conditions (METAR, TAFOR, etc.) with a simple recording system.

text: are defined,

text: The distinction between a low, a medium and a high level of robustness for this criterion is achieved through the level of assurance (see measurable and Comments table below).

text: adhered to

text: Criterion #3 3 Training covers assessment of meteorological conditions.

text: table below).

text: LEVEL of ASSURANCE ADVERSE OPERATING CONDITIONS Low Medium High

text: Criterion #1 Consider the criteria defined in Section 9 (Definition)

text: OSO #23

text: Environmental Comments N/A

text: conditions for — Procedures are validated against — Procedures do not require validation Same as Medium. In addition: safe operations standards considered adequate by the against either a standard or a means defined, competent authority and/or in Criterion #2 of compliance considered adequate by — Flight tests performed to validate the accordance with a means of measurable and (Procedures) the competent authority. procedures cover the complete flight compliance acceptable to that adhered to — The adequacy of the procedures and envelope or are proven to be authority. checklists is declared. conservative.

text: — The adequacy of the procedures is — The procedures, flight tests and proved through: simulations are validated by a — Dedicated flight tests, or competent third party. — Simulation, provided the simulation is proven valid for the intended purpose with positive results.

text: Comments N/A N/A N/A

text: — Training syllabus is available. A competent third party: Criterion #3 Training is self-declared (with evidence — The UAS operator provides — Validates the training syllabus. (Training) available). competency-based, theoretical and — Verifies the remote crew practical training competencies

text: Comments N/A N/A N/A

text: LEVEL of INTEGRITY ADVERSE OPERATING CONDITIONS N/A Medium High

text: The UAS is designed using environmental standards considered adequate by the The UAS is designed to limit the effect of OSO #24 Criteria N/A competent authority and/or in accordance environmental conditions. UAS is designed with a means of compliance acceptable to and qualified for that authority.

text: adverse environmental conditions

text: Comments N/A N/A N/A

text: LEVEL of ASSURANCE ADVERSE OPERATING CONDITIONS N/A Medium High OSO #24

text: Criteria N/A Consider the criteria defined in Section 9

text: UAS is designed and qualified for adverse

text: Comments N/A N/A

text: environmental conditions

text: LEVEL of ASSURANCE Low Medium High

text: The applicant declares that the required The applicant has supporting evidence EASA validates the claimed level of level of integrity has been achieved . that the required level of integrity is integrity. achieved. This is typically done by testing, Criteria 2 analysis, simulation , inspection, design TECHNICAL OSO review or through operational experience.

text: When simulation is used, the validity of Supporting evidence may or may not be Comments the targeted environment used in the N/A

text: available. simulation needs to be justified.

text: General 6.1 Means to monitor critical parameters for a safe flight should be available, in particular the: 6.1.1 UA position, height or altitude, ground speed or airspeed, attitude and trajectory; 6.1.2 UAS energy status (fuel, battery charge, etc.); and the 6.1.3 status of critical functions and systems; as a minimum, for services based on RF signals (e.g. C2 Link, GNSS, etc.), means should be provided to monitor the adequate performance and trigger an alert if the level becomes too low. 6.2 The UA should have the performance capability to descend safely from its operating altitude to a ‘safe altitude’ in less than a minute, or have a descent rate of at least 2.5 m/s (500 fpm).

text: Table PDRA-01.1 — Main limitations and provisions for PDRA-01

text: Figure PDRA-01.1 — Graphical representation of the SORA semantic model

text: Regulation (EU) 2016/679

text: of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive

text: (General Data Protection Regulation).

text: Regulation (EU) 2018/1139

text: of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations

text: (EC) No 2111/2005

text: (EC) No 1008/2008

text: (EU) No 996/2010

text: (EU) No 376/2014

text: and Directives

text: and

text: of the European Parliament and of the Council, and repealing Regulations

text: (EC) No 552/2004

text: and

text: (EC) No 216/2008

text: of the European Parliament and of the Council and

text: Council Regulation (EEC) No 3922/91

text: Regulation (EC) No 765/2008

text: of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing

text: Regulation (EEC) No 339/93

text: (OJ L 218, 13.8.2008, p. 30).

identifier: AMC & GM to Commission Implementing Regulation (EU) 2019-947 — Issue 1

amnesord: AMC & GM to Commission Implementing Regulation (EU) 2019/947

beslut: ED Decision 2019/021/R

title: AMC & GM to Commission Implementing Regulation (EU) 2019-947 — Issue 1

text: Annex I to ED Decision 2019/021/R

text: European Union Aviation Safety Agency

text: Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Commission Implementing

text: Regulation (EU) 2019/947

text: Issue 1 9 October 2019

text: Annex I to ED Decision 2019/021/R

text: LIST OF ABBREVIATIONS

text: AEC airspace encounter category AEH airborne electronic hardware ANSP air navigation service provider ARC air risk class AGL above ground level AMC acceptable means of compliance ATC air traffic control BVLOS beyond visual line of sight C2 command and control C3 command, control and communication ConOps concept of operations DAA detect and avoid EASA European Union Aviation Safety Agency ERP emergency response plan EU European Union FHSS frequency-hopping spread spectrum GRC ground risk class GM guidance material GNSS Global Navigation Satellite System HMI human machine interface ISM industrial, scientific and medical JARUS Joint Authorities for Rulemaking on Unmanned Systems METAR aviation routine weather report (in (aeronautical) meteorological code) MCC multi-crew cooperation MTOM maximum take-off mass NAA national aviation authority OM operations manual OSO operational safety objective PDRA predefined risk assessment RBO risk-based oversight RCP required communication performance RF radio frequency RLP required C2 link performance RPS remote pilot station SAIL specific assurance and integrity level SORA specific operations risk assessment STS standard scenario SW software TAF terminal area forecast

text: Annex I to ED Decision 2019/021/R

text: Article 1

text: Subject matter

text: AREAS OF APPLICABILITY OF THE UAS REGULATION For the purposes of the UAS Regulation, the term ‘operation of unmanned aircraft systems’ does not include indoor UAS operations. Indoor operations are operations that occur in or into a house or a building (dictionary definition) or, more generally, in or into a closed space such as a fuel tank, a silo, a cave or a mine where the likelihood of a UA escaping into the outside airspace is very low.

text: DEFINITION OF ‘ASSEMBLIES OF PEOPLE’ Assemblies of people have been defined by an objective criterion related to the possibility for an individual to move around in order to limit the consequences of an out-of-control UA. It was indeed difficult to propose a number of people above which this group of people would turn into an assembly of people: numbers were indeed proposed, but they showed quite a large variation. Qualitative examples of assemblies of people are: (a) sport, cultural, religious or political events; (b) beaches or parks on a sunny day; (c) commercial streets during the opening hours of the shops; and (d) ski resorts/tracks/lanes.

text: DEFINITION OF ‘DANGEROUS GOOD’ Under the definition of dangerous goods, blood may be considered to be capable of posing a hazard to health when it is contaminated or unchecked (potentially contaminated). In consideration of

text: Article 5(1)

text: (b)(iii): (a) medical samples such as uncontaminated blood can be transported in the ‘open’, ‘specific’ or ‘certified’ categories; (b) unchecked or contaminated blood must be transported in the ‘specific’ or the ‘certified’ categories. If the transport may result in a high risk for third parties, the UAS operation belongs to the ‘certified’ category (see

text: Article 6

text: 1.(b) (iii) of the UAS Regulation). If the blood is enclosed

text: Annex I to ED Decision 2019/021/R

text: in a container such that in case of an accident, the blood will not be spilled, the UAS operation may belong to the ‘specific’ category, if there are no other causes of high risk for third parties.

text: DEFINITION OF ‘AUTONOMOUS OPERATION’ Flight phases during which the remote pilot has no ability to intervene in the course of the aircraft, either following the implementation of emergency procedures, or due to a loss of the command-andcontrol connection, are not considered autonomous operations. An autonomous operation should not be confused with an automatic operation, which refers to an operation following pre-programmed instructions that the UAS executes while the remote pilot is able to intervene at any time.

text: DEFINITION OF ‘UNINVOLVED PERSONS’ Due to the huge variety of possible circumstances, this GM only provides general guidelines. An uninvolved person is a person that does not take part in the UAS operation, either directly or indirectly. A person may be considered to be ‘involved’ when they have: (a) given explicit consent to the UAS operator or to the remote pilot to be part of the UAS operation (even indirectly as a spectator or just accepting to be overflown by the UAS); and (b) received from the UAS operator or from the remote pilot clear instructions and safety precautions to follow in case the UAS exhibits any unplanned behaviour. In principle, in order to be considered a ‘person involved’, one: (a) is able to decide whether or not to participate in the UAS operation; (b) broadly understands the risks involved; (c) has reasonable safeguards during the UAS operations, introduced by the site manager and the aircraft operator; and (d) is not restricted from taking part in the event or activity if they decide not to participate in the UAS operation. The person involved is expected to follow the directions and safety precautions provided, and the UAS operator or remote pilot should check by asking simple questions to make sure that the directions and safety precautions have been properly understood. Spectators or any other people gathered for sport activities or other mass public events for which the UAS operation is not the primary focus are generally considered to be ‘uninvolved persons’. People sitting at a beach or in a park or walking on a street or on a road are also generally considered to be uninvolved persons. An example: when filming with a UAS at a large music festival or public event, it is not sufficient to inform the audience or anyone present via a public address system, or via a statement on the ticket,

text: Annex I to ED Decision 2019/021/R

text: or in advance by email or text message. Those types of communication channels do not satisfy the points above. In order to be considered a person involved, each person should be asked for their permission and be made aware of the possible risk(s). This type of operation does not fall into the ‘open’ category and may be classified as ‘specific’ or ‘certified’, according to the risk.

text: DEFINITION OF ‘MAXIMUM TAKE-OFF MASS (MTOM)’ This MTOM is the maximum mass defined by the manufacturer or the builder, in the case of privately built UAS, which ensures the controllability and mechanical resistance of the UA when flying within the operational limits. The MTOM should include all the elements on board the UA: (a) all the structural elements of the UA; (b) the motors; (c) the propellers, if installed; (d) all the electronic equipment and antennas; (e) the batteries and the maximum capacity of fuel, oil and all fluids; and (f) the heaviest payload allowed by the manufacturer, including sensors and their ancillary equipment.

text: Article 3

text: Categories of UAS operations

text: BOUNDARIES BETWEEN THE CATEGORIES OF UAS OPERATIONS (a) Boundary between ‘open’ and ‘specific’ A UAS operation does not belong to the ‘open’ category when at least one of the general criteria listed in Article 4 of the UAS Regulation is not met (e.g. when operating beyond visual line of sight (BVLOS)) or when the detailed criteria for a subcategory are not met (e.g. operating a 10 kg UA close to people when subcategory A2 is limited to 4 kg UA). (b) Boundary between ‘specific’ and ‘certified’ Article 6 of the UAS Regulation and

text: Article 40 of Regulation (EU) 2019/945

text: define the boundary between the ‘specific’ and the ‘certified’ category. The first article defines the boundary from an operational perspective, while the second one defines the technical characteristics of the UA, and they should be read together. A UAS operation belongs to the ‘certified’ category when, based on the risk assessment, the competent authority considers that the risk cannot be mitigated adequately without the: — certification of the airworthiness of the UAS; — certification of the UAS operator; and — licensing of the remote pilot, unless the UAS is fully autonomous. UAS operations are always considered to be in the ‘certified’ category when they:

text: Annex I to ED Decision 2019/021/R

text: — are conducted over assemblies of people with a UA that has characteristic dimensions of 3 m or more; or — involve the transport of people; or — involve the carriage of dangerous goods that may result in a high risk for third parties in the event of an accident.

text: Article 6

text: ‘Certified’ category of UAS operations

text: UAS OPERATIONS IN THE ‘CERTIFIED’ CATEGORY Article 6 of the UAS Regulation should be read together with

text: Article 40 of Regulation (EU) 2019/945

text: Article 6

text: addresses UAS operations and

text: Article 40

text: addresses the UAS. This construction was necessary to respect the EU legal order reflected in

text: Regulation (EU) 2018/1139

text: , which foresees that the requirements for UAS operations and registration are in the implementing act, and that the technical requirements for UAS are in the delegated act. The reading of the two articles results in the following: (a) the transport of people is always in the ‘certified’ category. Indeed, the UAS must be certified in accordance with

text: Article 40

text: and the transport of people is one of the UAS operations identified in

text: Article 6

text: as being in the ‘certified’ category; (b) flying over assemblies of people with a UAS that has a characteristic dimension of less than 3 m may be in the ‘specific’ category unless the risk assessment concludes that it is in the ‘certified’ category; and (c) the transport of dangerous goods is in the ‘certified’ category if the payload is not in a crash-protected container, such that there is a high risk for third parties in the case of an accident.

text: Article 9

text: Minimum age for remote pilots

text: SUPERVISOR A person may act as a remote pilot even if he or she has not reached the minimum age defined in Article 9(1) of the UAS Regulation, provided that the person is supervised. The supervising remote pilot must, in any case, comply with the age requirement specified in that Article. The possibility to lower the minimum age applies only to remote pilots (and not to supervisors). Since the supervisor and the young remote pilot must both demonstrate competency to act as a remote pilot, no minimum age is defined to conduct the training and pass the test to demonstrate the minimum competency to act as a remote pilot in the ‘open’ category.

text: GM1 to AMC1

text: Article 11

text: Rules for conducting an operational risk assessment

text: GENERAL The operational risk assessment required by Article 11 of the UAS Regulation may be conducted using the methodology described in AMC1 to

text: Article 11

text: . This methodology is basically the specific operations

text: Annex I to ED Decision 2019/021/R

text: risk assessment (SORA) developed by JARUS. Other methodologies might be used by the UAS operator as alternative means of compliance. Aspects other than safety, such as security, privacy, environmental protection, the use of the radio frequency (RF) spectrum, etc. should be assessed in accordance with the applicable requirements established by the Member State in which the operation is intended to take place, or by other EU regulations. For some UAS operations that are classified as being in the ‘specific’ category, alternatives to carrying out a full risk assessment are offered to UAS operators: (a) for UAS operations with lower intrinsic risks, a declaration may be submitted when the operations comply with the standard scenarios (STSs) listed in Appendix 1 to the UAS Regulation. Table 1 provides a summary of the STSs; and (b) for other UAS operations, a request for authorisation may be submitted based on the mitigations and provisions described in the predefined risk assessment (PDRA) when the UAS operation meets the operational characterisation described in AMC2 et seq. to

text: Article 11

text: to the UAS Regulation. Table 2 below provides a summary of the PDRA. While the STSs are described in a detailed way, the provisions and mitigations in the PDRA are described in a rather generic way to provide flexibility to UAS operators and the competent authorities to establish more prescriptive limitations and provisions that are adapted to the particularities of the intended operations. In accordance with Article 11 of the UAS Regulation, the applicant must collect and provide the relevant technical, operational and system information needed to assess the risk associated with the intended operation of the UAS, and the SORA (AMC1 to Article 11 of the UAS Regulation) provides a detailed framework for such data collection and presentation. The concept of operations (ConOps) description is the foundation for all other activities, and should be as accurate and detailed as possible. The ConOps should not only describe the operation, but also provide insight into the UAS operator’s operational safety culture. It should also include how and when to interact with the air navigation service provider (ANSP) when applicable. PDRAs only address safety risks; consequently, additional limitations and provisions might need to be included after the consideration of other risks (e.g. security, privacy, etc.).

text: Annex I to ED Decision 2019/021/R

text: Table 1 — List of STSs published as Appendix 1 to the UAS Regulation

text: up to 3 m and a typical kinetic energy populated areas 1 km up to 34 kJ

text: Table 2 — List of PDRAs published as AMC to

text: Article 11

text: to the UAS Regulation

text: Annex I to ED Decision 2019/021/R

text: Article 11

text: SPECIFIC OPERATIONS RISK ASSESSMENT (SOURCE JARUS SORA V2.0) EDITION September 2019

text: 1. Introduction 1.1 Preface (a) This SORA is based on the document developed by JARUS, providing a vision on how to safely create, evaluate and conduct an unmanned aircraft system (UAS) operation. The SORA provides a methodology to guide both the UAS operator and the competent authority in determining whether a UAS operation can be conducted in a safe manner. The document should not be used as a checklist, nor be expected to provide answers to all the challenges related to the integration of the UAS in the airspace. The SORA is a tailoring guide that allows a UAS operator to find a best fit mitigation means, and hence reduce the risk to an acceptable level. For this reason, it does not contain prescriptive requirements, but rather safety objectives to be met at various levels of robustness, commensurate with the risk. (b) The SORA is meant to inspire UAS operators and competent authorities and highlight the benefits of a harmonised risk assessment methodology. The feedback collected from real-life UAS operations will form the backbone of the updates in the upcoming revisions of the document. 1.2 Purpose of the document (a) The purpose of the SORA is to propose a methodology to be used as an acceptable means to demonstrate compliance with Article 11 of the UAS Regulation, that is to evaluate the risks and determine the acceptability of a proposed operation of a UAS within the ‘specific’ category. (b) Due to the operational differences and the expanded level of risk, the ‘specific’ category cannot automatically take credit for the safety and performance data demonstrated with the large number of UA operating in the ‘open ’ category. Therefore, the SORA provides a consistent approach to assess the additional risks associated with the expanded and new UAS operations that are not covered by the ‘open’ category. (c) The SORA is not intended as a one-stop-shop for the full integration of all types of UAS in all classes of airspace. (d) This methodology may be applied where the traditional approach to aircraft certification (approving the design, issuing an airworthiness approval and type certificate) may not be appropriate due to an applicant’s desire to operate a UAS in a limited or restricted manner. This methodology may also support the activities necessary to determine the associated airworthiness requirements. This assumes that the safety objectives set forth in, or derived from, those applicable for the ‘certified’ category, are consistent with the

text: Annex I to ED Decision 2019/021/R

text: ones set forth or derived for the ‘specific’ category. (e) The methodology is based on the principle of a holistic/total system safety risk-based assessment model used to evaluate the risks related to a given UAS operation. The model considers the nature of all the threats associated with a specified hazard, the relevant design, and the proposed operational mitigations for a specific UAS operation. The SORA then helps to evaluate the risks systematically, and determine the boundaries required for a safe operation. This method allows the applicant to determine the acceptable risk levels, and to validate that those levels are complied with by the proposed operations. The competent authority may also apply this methodology to gain confidence that the UAS operator can conduct the operation safely. (f) To avoid repetitive individual approvals, EASA will apply the methodology to define ‘standard scenarios’ or ‘predefined risk assessments’ for the identified types of ConOps with known hazards and acceptable risk mitigations. (g) The methodology, related processes, and values proposed in this document are intended to guide the UAS operator when performing a risk assessment in accordance with Article 11 of the UAS Regulation. 1.3 Applicability (a) The methodology presented in this document is aimed at evaluating the safety risks involved with the operation of UAS of any class, size or type of operation (including military, experimental, research and development and prototyping). It is particularly suited, but not limited to, ‘specific’ operations for which a hazard and a risk assessment are required. (b) The safety risks associated with collisions between UA and manned aircraft are in the scope of the methodology. The risk of a collision between two UA or between a UA and a UA carrying people will be addressed in future revisions of the document. (c) In the event of a mishap, the carriage of people or payloads on board the UAS (e.g. weapons) that present additional hazards is explicitly excluded from the scope of this methodology. (d) Security aspects are excluded from the applicability of this methodology when they are not limited to those confined by the airworthiness of the systems (e.g. the aspects relevant to protection from unlawful electromagnetic interference.) (e) Privacy and financial aspects are excluded from the applicability of this methodology. (f) The SORA can be used to support waiving the regulatory requirements applicable to the operation if it can be demonstrated that the operation can be conducted with an acceptable level of safety. (g) In addition to performing a SORA in accordance with the UAS Regulation, the UAS operator must also ensure compliance with all the other regulatory requirements applicable to the operation that are not necessarily addressed by the SORA. 1.4 Key concepts and definitions 1.4.1 Semantic model

text: Annex I to ED Decision 2019/021/R

text: (a) To facilitate effective communication of all aspects of the SORA, the methodology requires the standardised use of terminology for the phases of operation, procedures, and operational volumes. The semantic model shown in Figure 1 provides a consistent use of the terms for all SORA users. Figure 2 provides a graphical representation of the model and a visual reference to further aid the reader in understanding the SORA terminology.

text: Annex I to ED Decision 2019/021/R

text: 1.4.2 Introduction to robustness (a) To properly understand the SORA process, it is important to introduce the key concept of robustness. Any given risk mitigation or operational safety objective (OSO) can be demonstrated at differing levels of robustness. The SORA process proposes three different levels of robustness: low, medium and high, commensurate with the risk. (b) The robustness designation is achieved using both the level of integrity (i.e. safety gain)

text: provided by each mitigation, and the level of assurance (i.e. method of proof) that the

text: claimed safety gain has been achieved. These are both risk-based. (c) The activities used to substantiate the level of integrity are detailed in Annexes B, C, D and E. Those annexes provide either guidance material or reference industry standards and practices where applicable. (d) General guidance for the level of assurance is provided below: (1) A low level of assurance is where the applicant simply declares that the required level of integrity has been achieved. (2) A medium level of assurance is where the applicant provides supporting evidence that the required level of integrity has been achieved. This is typically achieved by means of testing (e.g. for technical mitigations) or by proof of experience (e.g. for human-related mitigations). (3) A high level of assurance is where the achieved integrity has been found to be acceptable by a competent third party. (e) The specific criteria defined in the Annexes take precedence over the criteria defined in paragraph d.

text: Annex I to ED Decision 2019/021/R

text: (f) Table 1 provides guidance to determine the level of robustness based on the level of integrity and the level of assurance: Low assurance Medium High assurance assurance Low integrity Low robustness Low robustness Low robustness Medium integrity Low robustness Medium Medium robustness robustness High integrity Low robustness Medium High robustness robustness

text: (g) For example, if an applicant demonstrates a medium level of integrity with a low level of assurance, the overall robustness will be considered to be low. In other words, the robustness will always be equal to the lowest level of either the integrity or the assurance. 1.5 Roles and responsibilities (a) While performing a SORA process and assessment, several key actors might be required to interact in different phases of the process. The main actors applicable to the SORA are described in this section. (b) UAS operator — The UAS operator is responsible for the safe operation of the UAS, and hence the safety risk analysis. In accordance with Article 5 of the UAS Regulation, the UAS operator must substantiate the safety of the operation by performing the specific operational and risk assessment, except for the cases defined by the same

text: Article 5

text: . Supporting material for the assessment may be provided by third parties (e.g. the manufacturer of the UAS or equipment, U-space service providers, etc.). The UAS operator obtains an operational authorisation from the competent authority/ANSP. (c) Applicant — The applicant is the party seeking operational approval. The applicant becomes the UAS operator once the operation has been approved. (d) UAS manufacturer — For the purposes of the SORA, the UAS manufacturer is the party that designs and/or produces the UAS. The UAS manufacturer has unique design evidence (e.g. for the system performance, the system architecture, software/hardware development documentation, test/analysis documentation, etc.) that they may choose to make available to one or many UAS operator(s) or to the competent authority to help to substantiate the UAS operator’s safety case. Alternatively, a potential UAS manufacturer may utilise the SORA to target design objectives for specific or generalised operations. To obtain airworthiness approval(s), these design objectives could be complemented by the use of certification specifications (CS) or industry consensus standards if they are found to be acceptable by the competent authority. (e) Component manufacturer — The component manufacturer is the party that designs and/or produces components for use in UAS operations. The component manufacturer has unique design evidence (e.g. for the system performance, the system architecture, software/hardware development documentation, test/analysis documentation, etc.) that they may choose to make available to one or many UAS operator(s) to substantiate a safety case.

text: Annex I to ED Decision 2019/021/R

text: (f) Competent authority — The competent authority is the recognised national authority for approving the safety case of UAS operations, according to Article 12 of the UAS Regulation. The competent authority may accept an applicant’s SORA submission in whole or in part. Through the SORA process, the applicant may need to consult with the competent authority to ensure the consistent application or interpretation of individual steps. The competent authority must perform oversight of the UAS operator according to paragraphs (i) and (j) of Article 18 of the UAS Regulation. EASA may perform oversight of the UAS design and/or production organisation, and, when considered necessary, of the component design and/or production organisation, and may approve the design and/or the production of each. The competent authority also provides the operational approval to the UAS operator. (g) ANSP — The ANSP is the designated provider of air traffic service in a specific area of operation (airspace). The ANSP assesses whether the proposed flight can be safely conducted in the particular airspace that it covers, and if so, authorises the flight. (h) U-space service provider — U-space service providers are entities that provide services to support the safe and efficient use of airspace. (i) Remote pilot — The remote pilot is designated by the UAS operator, or, in the case of general aviation, the aircraft owner, as being charged with safely conducting the flight.

text: 2. The SORA process 2.1 Introduction to risk (a) Many definitions of the word ‘risk’ exist in the literature. One of the easiest and most understandable definitions is provided in SAE ARP 4754A / EUROCAE ED-79A: ‘the combination of the frequency (probability) of an occurrence and its associated level of severity’. This definition of ‘risk’ is retained in this document. (b) The consequence of an occurrence will be designated as harm of some type. (c) Many different categories of harm arise from any given occurrence. Various authors on this topic have collated these categories of harm as supported by the literature. This document will focus on occurrences of harm (e.g. a UAS crash) that are short-lived and usually give rise to a near loss of life. Chronic events (e.g. toxic emissions over a period of time) are explicitly excluded from this assessment. The categories of harm in this document are the potential for: (1) fatal injuries to third parties on the ground; (2) fatal injuries to third parties in the air; or (3) damage to critical infrastructure. (d) It is acknowledged that the competent authorities, when appropriate, may consider additional categories of harm (e.g. the disruption of a community, environmental damage, financial loss, etc.). This methodology could also be used for those categories of harm. (e) Several studies have shown that the amount of energy needed to cause fatal injuries, in the case of a direct hit, is extremely low (i.e. in the region of few dozen Joules.) The energy

text: Annex I to ED Decision 2019/021/R

text: levels of operations addressed within this document are likely to be significantly higher, and therefore the retained harm is the potential for fatal injuries. By application of the methodology, the applicant has the opportunity to claim lower lethality either on a case-by-case basis, or systematically if allowed by the competent authorities (e.g. in the ‘open’ category). (f) Fatal injury is a well-defined condition and, in most countries, is known by the authorities. Therefore, the risk of under-reporting fatalities is almost non-existent. The quantification of the associated risk of fatality is straightforward. The usual means to measure fatalities is by the number of deaths within a particular time interval (e.g. the fatal accident rate per million flying hours), or the number of deaths for a specified circumstance (e.g. the fatal accident rate per number of take-offs). (g) Damage to critical infrastructure is a more complex condition. Therefore, the quantification of the associated risks may be difficult and subject to cooperation with the organisation responsible for the infrastructure. 2.2 SORA process outline (a) The SORA methodology provides a logical process to analyse the proposed ConOps and establish an adequate level of confidence that the operation can be conducted with an acceptable level of risk. There are ten steps that support the SORA methodology and each of these steps is described in the following paragraphs and further detailed, when necessary, in the relevant annexes. (b) The SORA focuses on the assessment of air and ground risks. In addition to air and ground risks, an additional risk assessment of critical infrastructure should also be performed. This should be done in cooperation with the organisation responsible for the infrastructure, as they are most knowledgeable of those threats. Figure 3 outlines the ten steps of the risk model, while Figure 4 provides an overall understanding of how to arrive at an air risk class (ARC) for a given operation.

text: Annex I to ED Decision 2019/021/R

text: Note: If operations are conducted across different environments, some steps may need to be repeated for each particular environment.

text: 2.2.1 Pre-application evaluation

text: (a) Before starting the SORA process, the applicant should verify that the proposed operation is feasible (i.e. not subject to specific exclusions from the competent authority or subject to an STS). Things to verify before beginning the SORA process are whether:

text: Annex I to ED Decision 2019/021/R

text: (1) the operation falls under the ‘open’ category; (2) the operation is covered by a ‘standard scenario’ included in the appendix to the UAS Regulation or by a ‘predefined risk assessment’ published by EASA; (3) the operation falls under the ‘certified’ category; or (4) the operation is subject to a specific NO-GO from the competent authority. If none of the above cases applies, the SORA process should be applied. 2.2.2 Step #1 — ConOps description (a) The first step of the SORA requires the applicant to collect and provide the relevant technical, operational and system information needed to assess the risk associated with the intended operation of the UAS. Annex A to this document provides a detailed framework for data collection and presentation. The ConOps description is the foundation for all other activities, and it should be as accurate and detailed as possible. The ConOps should not only describe the operation, but also provide insight into the UAS operator’s operational safety culture. It should also include how and when to interact with the ANSP. Therefore, when defining the ConOps, the UAS operator should give due consideration to all the steps, mitigations and OSOs provided in Figures 3 and 4. (b) Developing the ConOps can be an iterative process; therefore, as the SORA process is applied, additional mitigations and limitations may be identified, requiring additional associated technical details, procedures, and other information to be provided/updated in the ConOps. This should culminate in a comprehensive ConOps that fully and accurately describes the proposed operation as envisioned. 2.3 The ground risk process 2.3.1 Step #2 – Determination of the intrinsic UAS ground risk class (GRC) (a) The intrinsic UAS ground risk relates to the risk of a person being struck by the UAS (in the case of a loss of UAS control with a reasonable assumption of safety). (b) To establish the intrinsic GRC, the applicant needs the maximum UA characteristic dimension (e.g. the wingspan for a fixed-wing UAS, the blade diameter for rotorcraft, the maximum dimension for multi-copters, etc.) and the knowledge of the intended operational scenario. (c) The applicant needs to have defined the area at risk when conducting the operation including: (1) the operational volume, which is composed of the flight geography and the contingency volume. To determine the operational volume, the applicant should consider the position-keeping capabilities of the UAS in 4D space (latitude, longitude, height and time). In particular, the accuracy of the navigation solution, the flight technical error of the UAS and the path definition error (e.g. map errors),

text: Annex I to ED Decision 2019/021/R

text: and latencies should be considered and addressed in this determination;

text: (2) whether or not the area is a controlled ground area; and

text: (3) the associated ground risk buffer with at least a 1:1 rule , or for rotary wing UA, defined using a ballistic methodology approach acceptable to the competent authority.

text: (d) Table 2 illustrates how to determine the intrinsic ground risk class (GRC). The intrinsic GRC is found at the intersection of the applicable operational scenario and the maximum UA characteristic dimension that drives the UAS lethal area. In case of a mismatch between the maximum UAS characteristic dimension and the typical kinetic energy expected, the applicant should provide substantiation for the chosen column.

text: (e) The operational scenarios described attempt to provide discrete categorisations of

text: operations with increasing numbers of people at risk.

text: (f) Reserved.

text: (g) EVLOS operations are to be considered to be BVLOS for the intrinsic GRC determination.

text: Annex I to ED Decision 2019/021/R

text: (h) Controlled ground areas are a way to strategically mitigate the risk on ground (similar to flying in segregated airspace); the assurance that there will be uninvolved persons in the area of operation is under the full responsibility of the UAS operator. (i) An operation occurring in a populated environment cannot be intrinsically classified as being in a sparsely populated environment, even in cases where the footprint of the operation is completely within special risk areas (e.g. rivers, railways, and industrial estates). The applicant can make the claim for a lower density and/or shelter with Step #3 of the SORA process. (j) Operations that do not have a corresponding intrinsic GRC (i.e. grey cells on the table) are not supported by the SORA methodology. (k) When evaluating the typical kinetic energy expected for a given operation, the applicant should generally use the airspeed, in particular Vcruise for fixed-wing aircraft and the terminal velocity for other aircraft. Specific designs (e.g. gyrocopters) might need additional considerations. Guidance useful in determining the terminal velocity can be found at https://www.grc.nasa.gov/WWW/K-12/airplane/termv.html. (l) The nominal size of the crash area for most UAS can be anticipated by considering both the size and the energy used in the ground risk determination. There are certain cases or design aspects that are non-typical and will have a significant effect on the lethal area of the UAS, such as the amount of fuel, high-energy rotors/props, frangibility, material, etc. These may not have been considered in the intrinsic GRC determination table. These considerations may lead to a decrease/increase in the intrinsic GRC. The use of industry standards or dedicated research might provide a simplified path for this assessment. 2.3.2 Step #3 – Final GRC determination (a) The intrinsic risk of a person being struck by the UAS (in case of a loss of control of the operation) can be controlled and reduced by means of mitigation. (b) The mitigations used to modify the intrinsic GRC have a direct effect on the safety objectives associated with a particular operation, and therefore it is important to ensure their robustness. This has particular relevance for technical mitigations associated with the ground risk (e.g. an emergency parachute). (c) The final GRC determination (step #three) is based on the availability of these mitigations to the operation. Table 3 provides a list of potential mitigations and the associated relative correction factor. A positive number denotes an increase in the GRC, while a negative number results in a decrease in the GRC. All the mitigations should be applied in numeric sequence to perform the assessment. Annex B provides additional details on how to estimate the robustness of each mitigation. Competent authorities may define additional mitigations and the relative correction factors.

text: Annex I to ED Decision 2019/021/R

text: Mitigation Mitigations for ground risk

text: (d) When applying mitigation M1, the GRC cannot be reduced to a value lower than the lowest value in the applicable column in Table 2. This is because it is not possible to reduce the number of people at risk below that of a controlled area. (e) For example, in the case of a 2.5 m UAS (second column in Table 2) flying in visual lineof-sight (VLOS) over a sparsely populated area, the intrinsic GRC is 3. Upon analysis of the ConOps, the applicant claims to reduce the ground risk by first applying M1 at medium robustness (a GRC reduction of 2). In this case, the result of applying M1 is a GRC of 2, because the GRC cannot be reduced any lower than the lowest value for that column. The applicant then applies M2 using a parachute system, resulting in a further reduction of 1 (i.e. a GRC of 1). Finally, M3 (the ERP) has been developed to medium robustness with no further reduction as per Table 3. (f) The final GRC is established by adding all the correction factors (i.e. -1-1-0=-2) and adapting the GRC by the resulting number (3-2=1). (g) If the final GRC is greater than 7, the operation is not supported by the SORA process. 2.4 The air risk process 2.4.1 Air risk process overview (a) The SORA uses the operational airspace defined in the ConOps as the baseline to evaluate the intrinsic risk of a mid-air collision, and by determining the air risk category (ARC). The ARC may be modified/lowered by applying strategic and tactical mitigation means. The application of strategic mitigations may lower the ARC level. An example of strategic mitigations to reduce the risk of a collision may be by operating during certain time periods or within certain boundaries. After applying the strategic mitigations, any residual risk of a mid-air collision is addressed by means of tactical mitigations. (b) Tactical mitigations take the form of detect and avoid (DAA) systems or alternate means, such as ADS-B, FLARM, U-space services or operational procedures. Depending on the residual risk of a mid-air collision, the tactical mitigation performance requirement(s) (TMPR(s)) may vary.

text: Annex I to ED Decision 2019/021/R

text: (c) As part of the SORA process, the UAS operator should cooperate with the relevant service provider for the airspace (e.g. the ANSP or U-space service provider) and obtain the necessary authorisations. Additionally, generic local authorisations or local procedures allowing access to a certain portion of controlled airspace may be used if available (e.g. the Low Altitude Authorization and Notification Capability – LAANC – system in the United States). (d) Irrespective of the results of the risk assessment, the UAS operator should pay particular attention to all the features that may increase the detectability of the UA in the airspace. Therefore, technical solutions that improve the electronic conspicuousness or detectability of the UAS are recommended. 2.4.2 Step #4 - Determination of the initial air risk class (ARC) (a) The competent authority, ANSP, or U-space service provider, may elect to directly map the airspace collision risks using airspace characterisation studies. These maps would directly show the initial ARC for a particular volume of airspace. If the competent authority, ANSP, or U-space service provides an air collision risk map (static or dynamic), the applicant should use that service to determine the initial ARC, and go directly to Section 2.4.3 ‘Application of strategic mitigations’ to reduce the initial ARC. (b) As seen in Figure 4, the airspace is categorised into 13 aggregated collision risk categories. These categories were characterised by the altitude, controlled versus uncontrolled airspace, airport/heliport versus non-airport/non-heliport environments, airspace over urban versus rural environments, and lastly atypical (e.g. segregated) versus typical airspace. (c) To assign the proper ARC for the type of UAS operation, the applicant should use the decision tree found in Figure 4.

text: Annex I to ED Decision 2019/021/R

text: (d) The ARC is a qualitative classification of the rate at which a UAS would encounter a manned aircraft in typical generalised civil airspace. The ARC is an initial assignment of the aggregated collision risk for the airspace, before mitigations are applied. The actual collision risk of a specific local operational volume could be much different, and can be addressed with the application of strategic mitigations to reduce the ARC (this step is optional, see Section 2.4.3, Step #5). (e) Although the static generalised risk put forward by the ARC is conservative (i.e. it stays on the safe side), there may be situations where that conservative assessment may not suffice. It is important for both the competent authority and the UAS operator to take great care to understand the operational volume and under which circumstances the definitions in Figure 4 could be invalidated. In some situations, the competent authority may raise the operational volume ARC to a level which is greater than that advocated by Figure 4. The ANSP should be consulted to ensure that the assumptions related to the operational volume are accurate. (f) ARC-a is generally defined as airspace where the risk of a collision between a UAS and a manned aircraft is acceptable without the addition of any tactical mitigation.

text: Annex I to ED Decision 2019/021/R

text: (g) ARC-b, ARC-c, ARC-d generally define volumes of airspace with increasing risk of a collision between a UAS and a manned aircraft. (h) During the UAS operation, the operational volume may span many different airspace environments. The applicant needs to perform an air risk assessment for the entire range of the operational volume. An example scenario of operations in multiple airspace environments is provided at the end of Annex C. 2.4.3 Step #5 — Application of strategic mitigations to determine the residual ARC (optional) (a) As stated before, the ARC is a generalised qualitative classification of the rate at which a UAS would encounter a manned aircraft in the specific airspace environment. However, it is recognised that the UAS operational volume may have a different collision risk from the one that the generalised initial ARC assigned. (b) If an applicant considers that the generalised initial ARC assigned is too high for the condition in the local operational volume, then they should refer to Annex C for the ARC reduction process. (c) If the applicant considers that the generalised initial ARC assignment is correct for the condition in the local operational volume, then that ARC becomes the residual ARC. 2.4.4 Step #6 — TMPR and robustness levels Tactical mitigations are applied to mitigate any residual risk of a mid-air collision that is needed to achieve the applicable airspace safety objective. Tactical mitigations will take the form of either ‘see and avoid’ (i.e. operations under VLOS), or they may require a system which provides an alternate means of achieving the applicable airspace safety objective (operation using a DAA, or multiple DAA systems). Annex D provides the method for applying tactical mitigations. 2.4.4.1 Operations under VLOS/EVLOS (a) VLOS is considered to be an acceptable tactical mitigation for collision risk for all ARC levels. Notwithstanding the above, the UAS operator is advised to consider additional means to increase the situational awareness with regard to air traffic operating in the vicinity of the operational volume. (b) Operational UAS flights under VLOS do not need to meet the TMPR, nor the TMPR robustness requirements. In the case of multiple segments of the flight, those segments conducted under VLOS do not have to meet the TMPR, nor the TMPR robustness requirements, whereas those conducted under BVLOS do need to meet the TMPR and the TMPR robustness requirements. (c) In general, all VLOS requirements are applicable to EVLOS. EVLOS may have additional requirements over and above those of VLOS. The EVLOS verification and communication latency between the remote pilot and the observers should be less than 15 seconds. (d) Notwithstanding the above, the applicant should have a documented VLOS de-confliction scheme, in which the applicant explains which methods will be used for detection, and defines the associated criteria applied for the decision to avoid incoming traffic. If the remote pilot relies on detection by observers, the use of phraseology will have to be described as well.

text: Annex I to ED Decision 2019/021/R

text: (e) For VLOS operations, it is assumed that an observer is not able to detect traffic beyond 2 NM. (Note that the 2 NM range is not a fixed value and it may largely depend on the atmospheric conditions, aircraft size, geometry, closing rate, etc.). Therefore, the UAS operator may have to adjust the operation and/or the procedures accordingly. 2.4.4.2 Operations under a DAA system — TMPR (a) For operations other than VLOS, the applicant will use the residual ARC and Table 4 below to determine the TMPR.

text: (b) High TMPR (ARC-d): This is airspace where either the manned aircraft encounter rate is high, and/or the available strategic mitigations are low. Therefore, the resulting residual collision risk is high, and the TMPR is also high. In this airspace, the UAS may be operating in integrated airspace and will have to comply with the operating rules and procedures applicable to that airspace, without reducing the existing capacity, decreasing safety, negatively impacting current operations with manned aircraft, or increasing the risk to airspace users or persons and property on the ground. This is no different from the requirements for the integration of comparable new and novel technologies in manned aviation. The performance level(s) of those tactical mitigations and/or the required variety of tactical mitigations are generally higher than for the other ARCs. If operations in this airspace are conducted more routinely, the competent authority is expected to require the UAS operator to comply with the recognised DAA system standards (e.g. those developed by RTCA SC-228 and/or EUROCAE WG-105). (c) Medium TMPR (ARC-c): A medium TMPR will be required for operations in airspace where the chance of encountering manned aircraft is reasonable, and/or the strategic mitigations available are medium. Operations with a medium TMPR will likely be supported by the systems currently used in aviation to aid the remote pilot in the detection of other manned aircraft, or by systems designed to support aviation that are built to a corresponding level of robustness. Traffic avoidance manoeuvres could be more advanced than for a low TMPR. (d) Low TMPR (ARC-b): A low TMPR will be required for operations in airspace where the probability of encountering another manned aircraft is low, but not negligible, and/or where strategic mitigations address most of the risk, and the resulting residual collision risk is low. Operations with a low TMPR are supported by technology that is designed to aid the remote pilot in detecting other traffic, but which may be built to lower standards. For example, for operations below 120 m, the traffic avoidance manoeuvres are expected to mostly be based on a rapid descent to an altitude where manned aircraft are not expected to ever operate. (e) No performance requirement (ARC-a): This is airspace where the manned aircraft

text: Annex I to ED Decision 2019/021/R

text: encounter rate is expected to be extremely low, and therefore there is no requirement for a TMPR. It is generally defined as airspace where the risk of a collision between a UAS and a manned aircraft is acceptable without the addition of any tactical mitigation. An example of this may be UAS flight operations in some parts of Alaska or northern Sweden, where the manned aircraft density is so low that the airspace safety threshold could be met without any tactical mitigation. (f) Annex D provides information on how to satisfy the TMPR based on the available tactical mitigations and the TMPR level of robustness. 2.4.4.3 Consideration of additional airspace/operational requirements (a) Modifications to the initial and subsequent approvals may be required by the competent authority or the ANSP as safety and operational issues arise. (b) The UAS operator and the competent authority need to be cognisant that the ARCs are a generalised qualitative classification of the collision risk. Local circumstances could invalidate the aircraft density assumptions of the SORA, for example, due to special events. It is important for both the competent authority and the UAS operator to fully understand the airspace and air-traffic flows, and develop a system which can alert UAS operators to changes to the airspace on a local level. This will allow the UAS operator to safely address the increased risks associated with these events. (c) There are many airspace, operational and equipment requirements which have a direct impact on the collision risk of all aircraft in the airspace. Some of these requirements are general and apply to all volumes of airspace, while some are local and are required only for a particular volume of airspace. The SORA cannot possibly cover all the possible requirements for all the conditions in which the UAS operator may wish to operate. The applicant and the competent authority need to work closely together to define and address these additional requirements. (d) The SORA process should not be used to support operations of a UAS in a given airspace without the UAS being equipped with the required equipment for operations in that airspace (e.g. the equipment required to ensure interoperability with other airspace users). In these cases, specific exemptions may be granted by the competent authority. Those exemptions are outside the scope of the SORA. (e) Operations in controlled airspace, an airport/heliport environment or a Mode-C Veil/transponder mandatory zone (TMZ) will likely require prior approval from the ANSP. The applicant should ensure that they involve the ANSP/authority prior to commencing operations in these environments. 2.5 Final assignment of specific assurance and integrity level (SAIL) and OSO 2.5.1 Step #7 SAIL determination (a) The SAIL parameter consolidates the ground and air risk analyses, and drives the required activities. The SAIL represents the level of confidence that the UAS operation will remain under control. (b) After determining the final GRC and the residual ARC, it is then possible to derive the SAIL associated with the proposed ConOps.

text: Annex I to ED Decision 2019/021/R

text: (c) The level of confidence that the operation will remain under control is represented by the SAIL. The SAIL is not quantitative, but instead corresponds to: (1) the OSO to be complied with (see Table 6); (2) the description of the activities that might support compliance with those objectives; and (3) the evidence that indicates that the objectives have been satisfied. (d) The SAIL assigned to a particular ConOps is determined using Table 5: SAIL determination Residual ARC Final GRC a b c d ≤2 I II IV VI 3 II II IV VI 4 III III IV VI 5 IV IV IV VI 6 V V V VI 7 VI VI VI VI >7 Category C operation

text: 2.5.2 Step #8 — Identification of the operational safety objectives (OSOs) (a) The last step of the SORA process is to use the SAIL to evaluate the defences within the operation in the form of OSOs, and to determine the associated level of robustness. Table 6 provides a qualitative methodology to make this determination. In this table, O is optional, L is recommended with low robustness, M is recommended with medium robustness, and H is recommended with high robustness. The various OSOs are grouped based on the threat they help to mitigate; hence, some OSOs may be repeated in the table. (b) Table 6 is a consolidated list of the common OSOs that historically have been used to ensure safe UAS operations. It represents the collected experience of many experts, and is therefore a solid starting point to determine the required safety objectives for a specific operation. The competent authorities may define additional OSOs for a given SAIL and the associated level of robustness. OSO number (in

text: Technical issue with the UAS

text: OSO#01 Ensure the UAS operator is competent O L M H H H and/or proven OSO#02 UAS manufactured by competent O O L M H H and/or proven entity OSO#03 UAS maintained by competent and/or L L M M H H proven entity

text: Annex I to ED Decision 2019/021/R

text: OSO#04 UAS developed to authority 12 O O O L M H recognised design standards OSO#05 UAS is designed considering system O O L M H H safety and reliability OSO#06 C3 link performance is appropriate for O L L M H H the operation OSO#07 Inspection of the UAS (product inspection) to ensure consistency with L L M M H H the ConOps OSO#08 Operational procedures are defined, L M H H H H validated and adhered to OSO#09 Remote crew trained and current and L L M M H H able to control the abnormal situation OSO#10 Safe recovery from a technical issue L L M M H H

text: Deterioration of external systems supporting UAS operations

text: OSO#11 Procedures are in-place to handle the deterioration of external systems L M H H H H supporting UAS operations OSO#12 The UAS is designed to manage the deterioration of external systems L L M M H H supporting UAS operations OSO#13 External services supporting UAS operations are adequate for the L L M H H H operation

text: Human error

text: OSO#14 Operational procedures are defined, L M H H H H validated and adhered to OSO#15 Remote crew trained and current and L L M M H H able to control the abnormal situation OSO#16 Multi-crew coordination L L M M H H OSO#17 Remote crew is fit to operate L L M M H H OSO#18 Automatic protection of the flight O O L M H H envelope from human error OSO#19 Safe recovery from human error O O L M M H

text: Annex I to ED Decision 2019/021/R

text: OSO#20 A human factors evaluation has been performed and the human machine O L L M M H interface (HMI) found appropriate for the mission

text: Adverse operating conditions

text: OSO#21 Operational procedures are defined, L M H H H H validated and adhered to OSO#22 The remote crew is trained to identify critical environmental conditions and L L M M M H to avoid them OSO#23 Environmental conditions for safe operations are defined, measurable L L M M H H and adhered to OSO#24 UAS is designed and qualified for O O M H H H adverse environmental conditions

text: 2.5.3 Step #9 – Adjacent area/airspace considerations (a) The objective of this section is to address the risk posed by a loss of control of the operation, resulting in an infringement of the adjacent areas on the ground and/or adjacent airspace. These areas may vary with different flight phases. (b) Safety requirements for containment are: 13 14 1. No probable failure of the UAS or any external system supporting the operation should lead to operation outside the operational volume. Compliance with the requirement above shall be substantiated by a design and installation appraisal and shall include at least:  the design and installation features (independence, separation and redundancy);  any relevant particular risk (e.g. hail, ice, snow, electro-magnetic interference, etc.) associated with the ConOps. (c) The following three safety requirements apply for operations conducted: (1) either where the adjacent areas:

text: Annex I to ED Decision 2019/021/R

text: (i) contain assemblies of people unless the UAS is already approved for operations over assemblies of people; or (ii) are ARC-d unless the residual ARC of the airspace area intended to be flown within the operational volume is already ARC-d; (2) Or in populated environments where: (i) M1 mitigation has been applied to lower the GRC; or (ii) operating in a controlled ground area. -4 1. The probability of leaving the operational volume should be less than 10 /FH. 2. No single failure of the UAS or any external system supporting the operation should lead to its operation outside the ground risk buffer. Compliance with the requirements above should be substantiated by analysis and/or test data with supporting evidence.

text: Annex I to ED Decision 2019/021/R

text: (1) mitigations used to modify the intrinsic GRC; (2) strategic mitigations for the initial ARC; (3) tactical mitigations for the residual ARC; (4) adjacent area/airspace considerations; and (5) OSOs. (b) The satisfactory substantiation of the mitigations and objectives required by the SORA process provides a sufficient level of confidence that the proposed operation can be safely conducted. (c) The UAS operator should be sure to address any additional requirements that were not identified by the SORA process (e.g. for security, environmental protection, etc.) and identify the relevant stakeholders (e.g. environmental protection agencies, national security bodies, etc.). The activities performed within the SORA process will likely address those additional needs, but they may not be considered to be sufficient at all times. (d) The UAS operator should ensure the consistency between the SORA safety case and the actual operational conditions (i.e. at the time of the flight).

text: ANNEX A TO AMC1 TO ARTICLE 11

text: CONOPS: GUIDELINES ON COLLECTING AND PRESENTING SYSTEM AND OPERATIONAL INFORMATION FOR SPECIFIC UAS OPERATIONS

text: A.0 General guidelines

text: This document must be original work completed and understood by the applicant (operator). Applicants must take responsibility for their own safety cases, whether the material originates from this template or otherwise.

text: A.0.1 Document control

text: Applicants should include an amendment record at the beginning of the document to record changes and show how that the document is controlled.

text: Amendment/ Date Amended by Signed Revision/ Issue Number

text: a, b, c or 1, 2, 3 etc. DDMMYYYY Name of the person Signature of person carrying carrying out the out the amendment/ amendment/ revision/ revision/ issue number issue number

text: This section is critical to ensure appropriate document control. Any significant changes to the ConOps may require further assessment and approval by the competent authority prior to further operations being conducted.

text: Annex I to ED Decision 2019/021/R

text: A.0.2 References

text: (a) List all references (documents, URL, manuals, appendices) mentioned in the ConOps:

text: # Title Description Amendment/ Revision/ Issue Number

text: A.1 Guidance for the collection and presentation of operationally relevant information

text: The template below provides section headings detailing the subject areas that should be addressed when producing the ConOps, for the purposes of demonstrating that a UAS operation can be conducted safely. The template layouts as presented are not prescriptive, but the subject areas detailed should be included in the ConOps documentation as required for the particular operation(s), in order to provide the minimum required information and evidence to perform the SORA.

text: A.1.1 Reserved

text: A.1.2 Organisation overview

text: (a) This section describes how the organisation is defined, to support safe operations. It should include: (1) the structure of the organisation and its management, and (2) the responsibilities and duties of the UAS operator.

text: A.1.2.1 Safety

text: (a) The ‘specific’ category covers operations where the operational risks are higher and therefore the management of safety is particularly important. The applicant should describe how safety is integrated in the organisation, and the safety management system that is in place, if applicable. (b) Any additional safety-related information should be provided.

text: A.1.2.2 Design and production

text: (a) If the organisation is responsible for the design and/or production of the UAS, this section should describe the design and/or the production organisation. (b) It should provide information on the manufacturer of the UAS to be used if the UAS is not manufactured or produced by the operator, i.e. by a third-party manufacturer. (c) If required, information on the production organisation of the third-party organisation should be provided as evidence.

text: A.1.2.3 Training of staff involved in operations

text: This section should describe the training organisation or entity that qualifies all the staff involved in operations with respect to the ConOps.

text: A.1.2.4 Maintenance

text: Annex I to ED Decision 2019/021/R

text: This section should describe: (a) the general maintenance philosophy of the UAS; (b) the maintenance procedures for the UAS; and (c) the maintenance organisation, if required.

text: A.1.2.5 Crew

text: This section should describe: (a) the responsibilities and duties of personnel, including all the positions and people involved, for functions such as: (1) the remote pilot (including the composition of the flight team according to the nature of the operation, its complexity, the type of UAS, etc.); and (2) support personnel (e.g. visual observers (VOs), launch crew, and recovery crew); (b) the procedure for multi-crew coordination if more than one person is directly involved in the flight operations; (c) the operation of different types of UAS, including details of any limitations to the types of UAS that a remote pilot may operate, if appropriate; and (d) details of the operator’s policy on crew health requirements, including any procedures, guidance or references to ensure that the flight team are appropriately fit, capable and able to conduct the planned operations.

text: A.1.2.6 UAS configuration management

text: This section should describe how the operator manages changes to the UAS configuration.

text: A.1.2.7 Other position(s) and other information

text: Any other position defined in the organisation, or any other relevant information, should be provided.

text: A.1.3 Operations

text: A.1.3.1 Type of operations

text: (a) Detailed description of the ConOps: the applicant should describe what types of operations the UAS operator intends to carry out. The detailed description should contain all the information needed to obtain a detailed understanding of how, where and under which limitations or conditions the operations shall be performed. The operational volume, including the ground and air risk buffers, needs to be clearly defined. Relevant charts/diagrams, and any other information helpful to visualise and understand the intended operation(s) should be included in this section. (b) The applicant should provide specific details on the type of operations (e.g. VLOS, BVLOS), the population density to be overflown (e.g. away from people, sparsely populated, assemblies of people) and the type of airspace to be used (e.g. a segregated area, fully integrated).

text: Annex I to ED Decision 2019/021/R

text: (c) The applicant should describe the level of involvement (LoI) of the crew and any automated or autonomous systems during each phase of the flight.

text: A.1.3.2 Normal operation strategy

text: (a) The normal operation strategy should contain all the safety measures, such as technical or procedural measures, crew training, etc. that are put in place to ensure that the UAS can fulfil the operation within the approved limitations, and so that the operation remains in control. (b) Within this section, it should be assumed that all systems are working normally and as intended. (c) The intent of this chapter is to provide a clear understanding of how the operation takes place within the approved technical, environmental, and procedural limitations.

text: A.1.3.3 Standard operating procedures

text: This section should describe the standard operating procedures (SOP) applicable to all operations for which an approval is requested. A reference to the applicable operations manual (OM) is acceptable. Note: Checklists and SOP templates may be provided by the local competent authority or a qualified entity.

text: A.1.3.3.1 Normal operating procedures

text: This section should describe the normal operating procedures in place for the intended operations.

text: A.1.3.3.2 Contingency and emergency procedures

text: This section should describe the contingency procedures in place for any malfunction or abnormal operation, as well as an emergency.

text: A.1.3.3.3 Occurrence reporting procedures

text: UAS, like all aircraft, are subject to accident investigations and occurrence reporting schemes. Mandatory or voluntary reporting should be carried out using the reporting processes provided by the competent authorities. As a minimum, the SOP should contain: (a) reporting procedures in case of: (1) damage to property; (2) a collision with another aircraft; or (3) a serious or fatal injury (third parties and own personnel); and (b) documentation and data logging procedures: describe how records and information are stored and made available, if required, to the accident investigation body, competent authority, and other government entities (e.g. police) as applicable.

text: A.1.3.4 Operational limits

text: This section should detail the specific operating limitations and conditions appropriate to the proposed operation(s); for example, operating heights, horizontal distances, weather

text: Annex I to ED Decision 2019/021/R

text: conditions, the applicable flight performance envelope, times of operations (day and/or night) and any limitations for operating within the applicable class(es) of airspace, etc.

text: A.1.3.5 Emergency response plan (ERP)

text: The applicant should: (a) define a response plan for use in the event of a loss of control of the operation; (b) describe the procedures to limit the escalating effects of a crash; and (c) describe the procedures for use in the event of a loss of containment.

text: A.1.4 Remote crew training

text: A.1.4.1 General information

text: This section describes the processes and procedures that the UAS operator uses to develop and maintain the necessary competence for the remote crew (i.e. any person involved in the UAS operation).

text: A.1.4.2 Initial training and qualification

text: This section describes the processes and procedures that the UAS operator uses to ensure that the remote crew is suitably competent, and how the qualification of the remote crew is carried out.

text: A.1.4.3 Procedures for maintenance of currency

text: This section describes the processes and procedures that the UAS operator uses to ensure that the remote crew acquire and maintain the required currency to execute the various types of duties.

text: A.1.4.4 Flight simulation training devices (FSTDs)

text: This section: (a) describes the use of FSTDs for acquiring and maintaining the practical skills of the remote pilots (if applicable); and (b) describes the conditions and restrictions in connection with such training (if applicable).

text: A.1.4.5 Training programme

text: This section provides a reference to the applicable training programme(s) for the remote crew.

text: A2 Guidance for the collection and presentation of technical relevant information

text: The aim of this section is to collect all the necessary technical information about the UAS and its supporting systems. This information needs to be sufficient to address the required robustness levels of the mitigations and the OSOs of the SORA. The list below is suggested guidance for items which may be relevant for this assessment, but the items may differ, depending on the specific UAS utilised in this ConOps.

text: A.2.1 Reserved

text: A.2.2 UAS description

text: A.2.2.1 Unmanned aircraft (UA) segment

text: Annex I to ED Decision 2019/021/R

text: A.2.2.1.1 Airframe

text: This section should include the following: (a) A detailed description of the physical characteristics of the UA (mass, centre-of-mass, dimensions, etc.), including photos, diagrams and schematics, if appropriate to support the description of the UA. (1) Dimensions: for fixed-wing UA, the wingspan, fuselage length, body diameter etc.; for a rotorcraft, the length, width and height, propeller diameter, etc.; (2) Mass: all the relevant masses such as the empty mass, MTOM, etc.; and (3) Centre of gravity: the centre of gravity and limits if necessary. (b) Materials: the main materials used and where they are used in the UA, highlighting in particular any new materials (new metal alloys or composites) or combinations of materials (composites ‘tailored’ to designs). (c) Load limits: the capability of the airframe structure to withstand expected flight load limits. (d) Sub-systems: any sub-systems such as a hydraulic system, environmental control system, parachute, brakes, etc.

text: A.2.2.1.2 UA performance characteristics

text: This section should include the following: (a) the performance of the UA within the proposed flight envelope, specifically addressing at least the following items: (1) Performance: the (i) maximum altitude; (ii) maximum endurance; (iii) maximum range; (iv) maximum rate of climb; (v) maximum rate of descent; (vi) maximum bank angle; and (vii) turn rate limits. (2) Airspeeds: the (i) slowest speed attainable; (ii) stall speed (if applicable); (iii) nominal cruise speed; (iv) max cruise speed; and (v) never-exceed airspeed.

text: Annex I to ED Decision 2019/021/R

text: (b) Any performance limitations due to environmental and meteorological conditions, specifically addressing the following items: (1) wind speed limitations (headwind, crosswind, gusts); (2) turbulence restrictions; (3) rain, hail, snow, ash resistance or sensitivities; (4) the minimum visibility conditions, if applicable; (5) outside air temperature (OAT) limits; and (6) in-flight icing: (i) whether the proposed operating environment includes operations in icing conditions; (ii) whether the system has an icing detection capability, and if so, what indications, if any, the system provides to the remote pilot, and/or how the system responds; and (iii) any icing protection capability of the UA, including any test data that demonstrates the performance of the icing protection system.

text: A.2.2.1.3 Propulsion system

text: This section should include the following: (a) Principle A description of the propulsion system and its ability to provide reliable and sufficient power to take off, climb, and maintain flight at the expected mission altitudes. (b) Fuel-powered propulsion systems (1) The type (manufacturer organisation and model) of engine that is used; (2) How many engines are installed; (3) The type and the capacity of fuel that is used; (4) How the engine performance is monitored; (5) The status indicators, alerts (such as warning, caution and advisory), messages that are provided to the remote pilot; (6) A description of the most critical propulsion-related failure modes/conditions and their impact on the operation of the system; (7) How the UA responds, and the safeguards that are in place to mitigate the risk of a loss of engine power for each of the following: (i) fuel starvation; (ii) fuel contamination; (iii) failed signal input from the remote pilot station (RPS); and (iv) engine controller failure;

text: Annex I to ED Decision 2019/021/R

text: (8) The in-flight restart capabilities of the engine, if applicable, and if so, a description of the manual and/or automatic features of this capability; (9) The fuel system and how it allows for adequate control of the fuel delivery to the engine, and provides for aircrew determination of the fuel remaining. This includes a system level diagram showing the location of the system in the UA and the fuel flow path; and (10) How the fuel system is designed in terms of safety (fire detection and extinguishing, reduction of risk in case of impact, leak prevention, etc.). (c) Electric-powered propulsion systems (1) A high-level description of the electrical distribution architecture, including items such as regulators, switches, buses, and converters, as necessary; (2) The type of motor that is used; (3) The number of motors that are installed; (4) The maximum continuous power output of the motor in watts; (5) The maximum peak power output of the motor in watts; (6) The current range of the motor in amps; (7) Whether the propulsion system has a separate electrical source, and if not, how the power is managed with respect to the other systems of the UA; (8) A description of the electrical system and how it distributes adequate power to meet the requirements of the receiving systems. This should include a system level diagram showing the electrical power distribution throughout the UA; (9) How power is generated on board the UA (for example, generators, alternators, batteries). (10) If a limited life power source such as batteries is used, the useful life of the power source during normal and emergency conditions, and how this was determined; (11) How information on the battery status and the remaining battery capacity is provided to the remote pilot or the watchdog system; (12) If available, a description of the source(s) of backup power for use in the event of a loss of the primary power source. This should include: (i) the systems that are powered during backup power operation; (ii) a description of any automatic or manual load shedding; and (iii) how much operational time the backup power source provides, including the assumptions used to make this determination; (13) How the performance of the propulsion system is monitored; (14) The status indicators and alert (such as warning, caution and advisory) messages that are provided to the remote pilot; (15) A description of the most critical propulsion-related failure modes/conditions and

text: Annex I to ED Decision 2019/021/R

text: their impact on system operation; (16) How the UA responds, and the safeguards that are in place to mitigate the risk of a propulsion system loss for each of the following: (i) Low battery charge; (ii) A failed signal input from the RPS; and (iii) A motor controller failure; (17) If the motor has in-flight reset capabilities, a description of the manual and/or automatic features of this capability. (d) Other propulsion systems A description of these systems to a level of detail equivalent to the fuel and electrical propulsions sections above.

text: A.2.2.1.4 Flight control surfaces and actuators

text: This section should include the following: (a) A description of the design and operation of the flight control surfaces and servos/actuators, including a diagram showing the location of the control surfaces and the servos/actuators; (b) A description of any potential failure modes and the corresponding mitigations; (c) How the system responds to a servo/actuator failure; and (d) How the remote-pilot or watchdog system is alerted of a servo/actuator malfunction.

text: A.2.2.1.5 Sensors

text: This section should describe the non-payload sensor equipment on board the UA and its role.

text: A.2.2.1.6 Payloads

text: This section should describe the payload equipment on board the UA, including all the payload configurations that significantly change the weight and balance, electrical loads, or flight dynamics.

text: A.2.3 UAS control segment

text: This section should include the following:

text: A.2.3.1 General

text: An overall system architecture diagram of the avionics architecture, including the location of all air data sensors, antennas, radios, and navigation equipment. A description of any redundant systems, if available.

text: A.2.3.2 Navigation

text: (a) How the UAS determines its location; (b) How the UAS navigates to its intended destination; (c) How the remote pilot responds to instructions from:

text: Annex I to ED Decision 2019/021/R

text: (1) air traffic control; (2) UA observers or VOs (if applicable); and (3) other crew members (if applicable); (d) The procedures to test the altimeter navigation system (position, altitude); (e) How the system identifies and responds to a loss of the primary means of navigation; (f) A description of any backup means of navigation; and (g) How the system responds to a loss of the secondary means of navigation, if available.

text: A.2.3.3 Autopilot

text: (a) How the autopilot system was developed, and the industry or regulatory standards that were used in the development process. (b) If the autopilot is a commercial off-the-shelf (COTS) product, the type/design and the production organisation, with the criteria that were used in selecting the COTS autopilot. (c) The procedures used to install the autopilot and how its correct installation is verified, with references to any documents or procedures provided by the manufacturer’s organisation and/or developed by the UAS operator’s organisation. (d) If the autopilot employs input limit parameters to keep the aircraft within defined limits (structural, performance, flight envelope, etc.), a list of those limits and a description of how these limits were defined and validated. (e) The type of testing and validation that was performed (software-in-the-loop (SITL) and hardware-in-the-loop (HITL) simulations).

text: A.2.3.4 Flight control system

text: (a) How the control surfaces (if any) respond to commands from the flight control computer/autopilot. (b) A description of the flight modes (i.e. manual, artificial-stability, automatic, autonomous). (c) Flight control computer/autopilot: (1) If there are any auxiliary controls, how the flight control computer interfaces with the auxiliary controls, and how they are protected against unintended activation. (2) A description of the flight control computer interfaces required to determine the flight status and to issue appropriate commands. (3) The operating system on which the flight controls are based.

text: A.2.3.5 Remote pilot station (RPS)

text: (a) A description or a diagram of the RPS configuration, including screen captures of the control station displays. (b) How accurately the remote pilot can determine the attitude, altitude (or height) and position of the UA. (c) The accuracy of the transmission of critical parameters to other airspace users/air traffic

text: Annex I to ED Decision 2019/021/R

text: control (ATC). (d) The critical commands that are safeguarded from inadvertent activation and how that is achieved (for example, is there a two-step process to command ‘switch the engine off’). The kinds of inadvertent input that the remote pilot could enter to cause an undesirable outcome (for example, accidentally hitting the ‘kill engine’ control in flight). (e) Any other programmes that run concurrently on the ground control computer, and if there are any, the precautionary measures that are used to ensure that flight-critical processing will not be adversely affected. (f) The provisions that are made against an RPS display or interface lock-up. (g) The alerts (such as warning, caution and advisory) that the system provides to the remote pilot (e.g. low fuel or battery level, failure of critical systems, or operation out of control). (h) A description of the means to provide power to the RPS, and redundancies, if any.

text: A.2.3.6 Detect and avoid (DAA) system

text: (a) Aircraft conflict avoidance (1) A description of the system/equipment that is installed for collaborative conflict avoidance (e.g. SSR, TCAS, ADS-B, FLARM, etc.). (2) If the equipment is qualified, details of the detailed qualification to the respective standard. (3) If the equipment is not qualified, the criteria that were used in selecting the system. (b) Non-collaborative conflict avoidance: A description of the equipment that is installed (e.g. vision-based, PSR data, LIDAR, etc.). (c) Obstacle conflict avoidance A description of the system/equipment that is installed, if any, for obstacle collision avoidance. (d) Avoidance of adverse weather conditions A description of the system/equipment that is installed, if any, for the avoidance of adverse weather conditions. (e) Standard (1) If the equipment is qualified, a list of the detailed qualification to the respective standard. (2) If the equipment is not qualified, the criteria that were used in selecting the system. (f) A description of any interface between the conflict avoidance system and the flight control computer. (g) A description of the principles that govern the installed DAA system

text: Annex I to ED Decision 2019/021/R

text: (h) A description of the role of the remote pilot or any other remote crew in the DAA system. (i) A description of the known limitations of the DAA system.

text: A.2.4 Containment system

text: (a) A description of the principles of the system/equipment used to perform containment functions for: (1) avoidance of specific area(s) or volume(s); or (2) confinement in a given area or volume. (b) The system information and, if applicable, supporting evidence that demonstrates the reliability of the containment system.

text: A.2.5 Ground support equipment (GSE) segment

text: (a) A description of all the support equipment that is used on the ground, such as launch or recovery systems, generators, and power supplies. (b) A description of the standard equipment available, and the backup or emergency equipment. (c) A description of how the UAS is transported on the ground.

text: A.2.6 Command and control (C2) link segment

text: (a) The standard(s) with which the system is compliant. (b) A detailed diagram that shows the system architecture of the C2 link, including informational or data flows and the performance of the subsystem, and values for the data rates and latencies, if known. (c) A description of the control link(s) connecting the UA to the RPS and any other ground systems or infrastructures, if applicable, specifically addressing the following items: (1) The spectrum that will be used for the control link and how the use of this spectrum has been coordinated. If approval of the spectrum is not required, the regulation that was used to authorise the frequency. (2) The type of signal processing and/or link security (i.e. encryption) that is employed. (3) The datalink margin in terms of the overall link bandwidth at the maximum anticipated distance from the RPS, and how it was determined. (4) If there is a radio signal strength and/or health indicator or similar display to the remote pilot, how the signal strength and health values were determined, and the threshold values that represent a critically degraded signal. (5) If the system employs redundant and/or independent control links, how different the design is, and the likely common failure modes. (6) For satellite links, an estimate of the latencies associated with using the satellite link for aircraft control and for air traffic control communications. (7) The design characteristics that prevent or mitigate the loss of the datalink due to the following:

text: Annex I to ED Decision 2019/021/R

text: (i) RF or other interference; (ii) flight beyond the communications range; (iii) antenna masking (during turns and/or at high attitude angles); (iv) a loss of functionality of the RPS; (v) a loss of functionality of the UA; and (vi) atmospheric attenuation, including precipitation.

text: A.2.7 C2 link degradation

text: A description of the system functions in case of a C2 link degradation: (a) Whether the C2 link degradation status is available and in what form (e.g. degraded, critical, automatic messages). (b) How the status of the C2 link degradation is announced to the remote pilot (e.g. visual, haptic, or sound). A description of the associated contingency procedures. (c) Other.

text: A.2.8 C2 link loss

text: (a) The conditions that could lead to a loss of the C2 link. (b) The measures in case of a loss of the C2 link. (c) A description of the clear and distinct aural and visual alerts to the remote pilot for any case of a lost link. (d) A description of the established lost link strategy presented in the UAS operating manual, taking into account the emergency recovery capability. (e) A description of how the geo-awareness or geo-fencing system is used in this case, if available. (f) The lost link strategy, and, if incorporated, the re-acquisition process in order to try to reestablish the link in a reasonably short time.

text: A.2.9. Safety features

text: (a) A description of the single failure modes and their recovery mode(s), if any. (b) A description of the emergency recovery capability to prevent risks to third-parties. This typically consists of: (1) a flight termination system (FTS), procedure or function that aims to immediately end the flight; or (2) an automatic recovery system (ARS) that is implemented through UAS crew command or by the on board systems. This may include an automatic pre-programmed course of action to reach a predefined and unpopulated forced landing area; or (3) any combination of the above, or other methods.

text: Annex I to ED Decision 2019/021/R

text: (c) The applicant should provide both a functional and physical diagram of the global UA system with a clear depiction of its constituent components, and, where applicable, an indication of its peculiar features (e.g. independent power supplies, redundancies, etc.)

text: ANNEX B TO AMC1 TO ARTICLE 11

text: INTEGRITY AND ASSURANCE LEVELS FOR THE MITIGATIONS USED TO REDUCE THE INTRINSIC GROUND RISK CLASS (GRC)

text: B.1 How to use Annex B

text: The following Table B-1 provides the basic principles to consider when using SORA Annex B.

text: #1 Annex B provides assessment criteria for the The identification of mitigations is the responsibility integrity (i.e. safety gain) and assurance (i.e. of the applicant. method of proof) of the applicant’s proposed mitigations. The proposed mitigations are intended to reduce the intrinsic ground risk class (GRC) associated with a given operation. #2 Annex B does not cover the LoI of the competent authority. The Lol is based on the competent authority’s assessment of the applicant’s ability to perform the given operation. #3 A proposed mitigation may or may not have a positive effect in reducing the ground risk associated with a given operation. In the case where a mitigation is available but does not reduce the risk on the ground, its level of integrity should be considered equivalent to ‘None’. #4 To achieve a given level of integrity/assurance, when more than one criterion exists for that level of integrity/assurance, all the applicable criteria need to be met. #5 Annex B intentionally uses non-prescriptive terms (e.g. suitable, reasonably practicable) to provide flexibility to both the applicant and the competent authorities. This does not constrain the applicant in proposing mitigations, nor the competent authority in evaluating what is needed on a case-by-case basis. #6 This annex in its entirety also applies to single-person organisations.

text: Table B.1 – Basic principles

text: Annex I to ED Decision 2019/021/R

text: B.2 M1 – Strategic mitigations for ground risk

text: M1 mitigations are ‘strategic mitigations’ intended to reduce the number of people at risk on the ground. To assess the integrity levels of M1 mitigations, the following need to be considered:

text: (a) the definition of the ground risk buffer and the resulting ground footprint; and

text: (b) the evaluation of the people at risk.

text: With the exception of the specific case of a ‘tether’ provided in the following paragraph (2), the generic criteria to assess the level of integrity (Table B.2) and level of assurance (Table B.3) of the M1 type ground risk mitigations are provided in following paragraph (1).

text: (1) Generic criteria

text: Level of integrity Low Medium High

text: The ground risk buffer takes into 3 Same as medium consideration: (a) improbable single malfunctions or failures (including the projection of high energy parts A ground risk buffer such as rotors and propellers) with at least a 1:1 which would lead to an operation rule or for rotary outside the operational volume; Criterion #1 wing UA defined using (Definition of (b)meteorological conditions (e.g. a ballistic the ground risk wind); methodology buffer) approach acceptable (c) UAS latencies (e.g. latencies that to the competent affect the timely manoeuvrability authority. of the UA); (d)UA behaviour when activating a technical containment measure; M1 — Strategic and

text: mitigations for

text: (e) UA performance.

text: ground risk

text: For the purpose of this assessment, the term ‘improbable’

text: 1 should be interpreted in a qualitative way as ‘Unlikely to If the UA is planned occur in each UAS during its total life, but which may occur to operate at an

text: altitude of 150 m, the several times when considering the total operational life of

text: Comments

text: ground risk buffer a number of UAS of this type’. should be a minimum The distinction between a medium and a high level of of 150 m. robustness for this criterion is achieved through the level of assurance (Table 3 below).

text: The applicant The applicant evaluates the area of evaluates the area of Criterion #2 operations by use of authoritative operations by means (Evaluation of density data (e.g. data from the Same as medium. of on-site inspections people at risk) U-space data service provider) or appropriate appraisals to justify relevant for the proposed area and lowering the density

text: Annex I to ED Decision 2019/021/R

text: Level of integrity Low Medium High

text: of the people at risk time of operation to substantiate a (e.g. a residential lower density of people at risk. area during daytime If the applicant claims a reduction, when some people due to a sheltered operational may not be present environment, the applicant: or an industrial area (a) uses a UA of less than 25 kg and at night time for the not flying above 174 knots , and same reason). (b)demonstrates that although the operation is conducted in a populated environment, it is reasonable to consider that most of the non-involved persons will be located within a building .

text: as per MITRE presentation given during the UAS Technical Analysis and Applications Center (TAAC) conference in 2016 titled ‘UAS EXCOM Science and Research Panel Comments N/A N/A (SARP) 2016 TAAC Update’ - PR 16-3979 The consideration of this mitigation may vary based on the local

text: conditions.

text: Annex I to ED Decision 2019/021/R

text: Level of assurance Low Medium High

text: The applicant declares The applicant has supporting evidence The claimed level that the required level to claim that the required level of of integrity is Criterion #1 of integrity is integrity has been achieved. This is validated by a (Definition of 1 achieved . typically done by means of testing, competent third the ground 2 analysis, simulation , inspection, design party. risk buffer) review or through operational experience.

text: Supporting evidence When simulation is used, the validity of

text: Comments may or may not be the targeted environment used in the N/A available. simulation needs to be justified.

text: The applicant declares The density data used for the claim of Same as medium; M1 — that the required level risk reduction is an average density map however, the

text: Strategic

text: of integrity has been for the date/time of the operation from density data used mitigations 3 achieved . a static sourcing (e.g. census data for for the claim of

text: for ground

text: night time ops). risk reduction is a

text: risk

text: near-real time Criterion #2 In addition, for localised operations (e.g. density map from (Evaluation of intra-city delivery or infrastructure a dynamic people at risk) inspection), the applicant submits the sourcing (e.g. proposed route/area of operation to the cellular user data) applicable authority (e.g. city police, and applicable for office of civil protection, infrastructure the date/time of owner etc.) to verify the claim of a the operation. reduced number of people at risk.

text: Supporting evidence Comments may or may not be N/A N/A available

text: Table B.3 — Level of assurance assessment criteria for ground risk of non-tethered M1 mitigations

text: Annex I to ED Decision 2019/021/R

text: (2) Specific criteria in case of use of a tether to reduce people at risk

text: When an applicant wants to take credit for a tether to justify a reduction in the number of people at risk:

text: (a) the tether needs to be considered part of the UAS and assessed based on the criteria below, and

text: (b) potential hazards created by the tether itself should be addressed through the OSOs defined in Annex E.

text: The level of integrity criteria for a tethered mitigation is found in Table B.4. The level of assurance for a tethered mitigation is found in Table B.5.

text: Level of integrity Low Medium High

text: (a) The length of the line is 2 Does not meet the Same as medium adequate to contain the UA ‘medium’ level criteria in the operational volume and reduce the number of people at risk. (b) The strength of the line is compatible with the Criterion #1 ultimate loads expected (Technical during the operation. design) (c) The strength of the attachment points is compatible with the ultimate loads expected during the operation. (d) The tether cannot be cut by

text: M1 — Tethered

text: the rotating propellers.

text: operation

text: Ultimate loads are identified as the maximum loads to be expected in service, including all the possible nominal and

text: failure scenarios multiplied by a 1.5 safety factor.

text: Comments N/A The distinction between a medium and a high level of

text: robustness for this criterion is achieved through the level of assurance (Table B.5 below). The applicant has procedures 3 Does not meet the Same as medium Criterion #2 to install and periodically ‘medium’ level criteria (Procedures) inspect the condition of the tether.

text: The distinction between a medium and a high level of

text: Comments N/A robustness for this criterion is achieved through the level of assurance (Table B.5 below).

text: Table B.4 — Level of integrity assessment criteria for ground risk tethered M1 mitigations

text: Level of assurance

text: Annex I to ED Decision 2019/021/R

text: Low Medium High

text: The applicant has supporting Does not meet the The claimed level of evidence (including the ‘medium’ level criteria integrity is validated by specifications of the tether EASA. material) to claim that the

text: required level of integrity is

text: achieved.

text: (a) This is typically achieved Criterion #1 through testing or (Technical operational experience. design)

text: (b)Tests can be based on

text: simulations; however, the

text: validity of the target

text: environment used in the

text: simulation needs to be

text: justified.

text: Comments N/A N/A N/A

text: (a) Procedures are validated

text: against standards

text: M1 —

text: considered adequate by

text: Tethered

text: the competent authority operation (a) Procedures do not and/or in accordance with Same as medium. In require validation a means of compliance addition: against either a acceptable to that standard or a (a) Flight tests performed authority. means of to validate the

text: compliance (b)Adequacy of the procedures cover the considered procedures is proven Criterion #2 complete flight adequate by the through: (Procedures) envelope or are proven competent to be conservative. (1) dedicated flight authority. tests; or (b) The procedures, flight

text: (b) The adequacy of tests and simulations (2) simulation, the procedures and provided the are validated by a checklists is simulation is proven competent third party. declared. valid for the

text: intended purpose

text: with positive

text: results.

text: Comments N/A N/A N/A

text: Table B.5 — Level of assurance assessment criteria for ground risk tethered M1 mitigations B.3 M2 — Effects of ground impact are reduced

text: M2 mitigations are intended to reduce the effect of ground impact once the control of the operation is lost.

text: This is done by reducing the effect of the UA impact dynamics (i.e. the area, energy, impulse, transfer energy,

text: etc.). One example would be the use of a parachute.

text: Level of integrity

text: Annex I to ED Decision 2019/021/R

text: Low/None Medium High

text: (a) Effects of impact Same as medium. In addition: dynamics and post impact hazards are (a) When applicable, the significantly reduced activation of the mitigation is although it can be automated . assumed that a fatality (b) The effects of impact may still occur. dynamics and post impact (b) When applicable, in case hazards are reduced to a of malfunctions, failures level where it can be Criterion #1 or any combinations reasonably assumed that a Does not meet the 3 (Technical thereof that may lead to a fatality will not occur . ‘medium’ level criterion design) crash, the UAS contains all the elements required for the activation of the mitigation. (c) When applicable, any failure or malfunction of

text: M2 —

text: the proposed mitigation

text: Effects of

text: itself (e.g. inadvertent

text: UA impact

text: activation) does not

text: dynamics

text: adversely affect the

text: are

text: safety of the operation.

text: reduced

text: (e.g. The applicant retains the parachute) discretion to implement an

text: additional manual activation

text: 1 function.

text: Examples of post impact Comments N/A hazards include fires and the 3 Emerging research and

text: release of high-energy parts.

text: upcoming industry standards will help applicants to substantiate compliance with

text: this integrity criterion. Criterion #2 Any equipment used to reduce the effect of the UA impact dynamics is installed and (Procedures, 4 maintained in accordance with the manufacturer’s instructions.

text: if applicable)

text: Comments / The distinction between a low, a medium and a high level of robustness for this criterion is Notes achieved through the level of assurance (Table B.7 below). Criterion #3 Personnel responsible for the installation and maintenance of the measures proposed to (Training, if 5 reduce the effect of the UA impact dynamics are identified and trained by the applicant.

text: applicable)

text: Comments / The distinction between a low, a medium and a high level of robustness for this criterion is Notes achieved through the level of assurance (Table B.7 below).

text: Table B.6 — Level of integrity assessment criteria for M2 mitigations

text: Level of assurance M2 — Effects of Low/None Medium High

text: Annex I to ED Decision 2019/021/R

text: UA impact The applicant declares that The applicant has The claimed level of integrity is

text: dynamics the required level of supporting evidence to validated by EASA against a

text: are integrity has been claim that the required standard considered adequate

text: reduced achieved . level of integrity is by EASA and/or in accordance Criterion #1 2 (e.g. achieved. This is typically with means of compliance (Technical parachute) done by means of testing, acceptable to EASA (when design) 3 analysis, simulation , applicable).

text: inspection, design review

text: or through operational

text: experience.

text: The use of industry standards is encouraged when developing mitigations used to reduce

text: 1 the effect of ground Supporting evidence may

text: Comments impact.

text: or may not be available. 3

text: When simulation is used,

text: the validity of the targeted environment used in the simulation needs to be

text: justified.

text: (a) Procedures are

text: validated against

text: standards considered

text: adequate by the

text: competent authority

text: and/or in accordance

text: with means of (a) Procedures do not compliance acceptable Same as medium. In addition: require validation to that authority. against either a (a) Flight tests performed to standard or a means (b) The adequacy of the validate the procedures of compliance procedures is proven Criterion #2 cover the complete flight considered adequate through: (Procedures, envelope or are proven to be by the competent if applicable) (1) dedicated flight conservative. authority. tests; or (b) The procedures, flight tests (b) The adequacy of the (2) simulation, and simulations are validated procedures and provided that the by a competent third party. checklists is declared. representativenes

text: s of the

text: simulation means

text: is proven for the

text: intended purpose

text: with positive

text: results.

text: Comments N/A N/A

text: Criterion #3 (a) Training syllabus is (a) Training syllabus is validated Training is self-declared (Training, if available. by a competent third party.

text: (with evidence available) applicable)

text: Annex I to ED Decision 2019/021/R

text: (b) The UAS operator (b) Remote crew competencies provides are verified by a competent competency-based, third party. theoretical and practical training.

text: Comments N/A N/A N/A

text: Table B.7 - Level of assurance assessment criteria for M2 mitigations B.4 M3 — An ERP is in place, UAS operator validated and effective

text: An ERP should be defined by the applicant in the event of a loss of control of the operation (*). These are emergency situations where the operation is in an unrecoverable state and in which:

text: (a) the outcome of the situation relies highly on providence; or

text: (b) it could not be handled by a contingency procedure; or

text: (c) when there is a grave and imminent danger of fatalities.

text: The ERP proposed by an applicant is different from the emergency procedures. The ERP is expected to cover:

text: (1) a plan to limit the escalating effect of a crash (e.g. to notify first responders), and

text: (2) the conditions to alert ATM.

text: (*) Refer to the SORA semantic model (Figure 1) in the main body.

text: Level of integrity Low/None Medium High

text: The ERP: Same as medium. In (a) is suitable for the situation; addition, in case of a loss M3 — An No ERP is available, or (b)limits the escalating effects; of control of the ERP is in the ERP does not cover operation, the ERP is (c) defines criteria to identify an place, UAS Criteria the elements identified shown to significantly emergency situation; operator to meet a ‘medium’ or reduce the number of validated ‘high’ level of integrity (d)is practical to use; people at risk, although it and can be assumed that a (e) clearly delineates the duties effective fatality may still occur. of remote crew member(s).

text: Comments N/A N/A N/A

text: Table B.8 — Level of integrity assessment criteria for M3 mitigations

text: Level of assurance Low/None Medium High

text: (a) Procedures do not (a) The ERP is developed to M3 — An Same as medium. In addition: require validation standards considered ERP is in (a) The ERP and the Criterion #1 against either a adequate by the place, UAS effectiveness of the plan (Procedures) standard or a means competent authority operator with respect to limiting the of compliance and/or in accordance with validated number of people at risk considered adequate means of compliance

text: Annex I to ED Decision 2019/021/R

text: Level of assurance Low/None Medium High

text: and by the competent acceptable to that are validated by a effective authority. authority. competent third party. (b) The adequacy of the (b)The ERP is validated (b)The applicant has procedures and through a representative coordinated and agreed checklists is declared. tabletop exercise the ERP with all third consistent with the ERP parties identified in the training syllabus. plan. (c) The representativeness of the tabletop exercise is validated by a competent third party.

text: The tabletop exercise may or Comments N/A may not involve all third N/A

text: parties identified in the ERP. (a) An ERP training syllabus is available. Same as medium. In addition, (b)A record of the ERP Criterion #2 Does not meet the competencies of the relevant training completed by the (Training) ‘medium’ level criterion staff are verified by a relevant staff is competent third party. established and kept up to date.

text: Comments N/A N/A N/A

text: Table B.9 — Level of assurance assessment criteria for M3 mitigations

text: Annex I to ED Decision 2019/021/R

text: ANNEX C TO AMC1 TO ARTICLE 11

text: STRATEGIC MITIGATION — COLLISION RISK ASSESSMENT

text: C.1 Introduction — air risk strategic mitigations

text: The target audience for Annex C is the UAS operator who wishes to demonstrate to the competent authority that the risk of a mid-air collision in the operational volume is acceptably safe, and to obtain, with concurrence from the ANSP, approval to operate in the particular airspace. More particularly, this Annex C covers the process of how the UAS operator justifies lowering the initial assessment of the ARC. The air risk model provides a holistic means to assess the risk of an encounter with manned aircraft. This provides guidance to both the UAS operator and the competent authority on determining whether an operation can be conducted in a safe manner. The model does not provide answers to all the air risk challenges, and should not be used as a checklist. This guidance provides the UAS operator with suitable mitigation means and thereby reduces the air risk to an acceptable level. This guidance does not contain prescriptive requirements, but rather a set of objectives at various levels of robustness.

text: C.2 Principles

text: The SORA is only used to establish an initial ARC for an operational volume when the competent authority has not already established one. The initial ARC is a generalised qualitative classification of the rate at which a UAS would encounter a manned aircraft in the operational volume. A residual ARC is the classification after mitigations are applied. The UAS operational volume may have collision risk levels that differ from the generalised initial ARC level. If this is assumed to be the case, this Annex provides a process to help the UAS operator and the competent authority work to lower the initial ARC through the application of strategic mitigations.

text: C.3 Air risk scope and assumptions

text: The scope of this air risk assessment is designed to help the UAS operator and the competent authority in determining the risk of a collision with manned aircraft which are operated under the ‘specific’ category. The scope of the air risk assessment does not include: (a) the probability of UAS on UAS encounters; or (b) risks due to wake turbulence, adverse weather, controlled flight into terrain, return-tocourse functions, a lost link, or an automatic response.

text: C.3.1 SORA qualitative vs quantitative approach

text: This air risk assessment is qualitative in nature. Where possible, this assessment will use quantitative data to back up and support the qualitative assumptions. The SORA approach in general provides a balance between qualitative and quantitative approaches, as well as between known prescriptive and non-traditional methodologies.

text: Annex I to ED Decision 2019/021/R

text: C.3.2 SORA U-space assumptions

text: The SORA has used U-space mitigations to a limited extent, because U-space is in the early stages of development. When U-space provides adequate mitigations to limit the risk of UAS encounters with manned aircraft, a UAS operator can apply for, and obtain credit for these mitigations, whether they are tactical or strategic.

text: C.3.3 SORA flight rules assumptions

text: Today, UAS flight operations under the ‘specific’ category cannot fully comply with the IFR and VFR rules as written. Although IFR infrastructures and mitigations are designed for manned aircraft operations (e.g. minimal safe altitudes, equipage requirements, operational restrictions, etc.), it may be possible for a UAS to comply with the IFR requirements. UAS operating at very low levels (e.g. 400 ft AGL and below) may technically comply with the IFR rules, but the IFR infrastructure was not designed with that airspace in mind; therefore, mitigations for this airspace would be derived, and highly impractical and inefficient. When operating BVLOS, a UAS cannot comply with VFR . Given the above, for the purposes of this risk assessment, it is assumed that the competent authority will address these shortcomings. All aircraft must adhere to specific flight rules to mitigate the collision risk, in accordance with

text: Regulation (EU) No 923/2012

text: (the standardised European rules of the air (SERA) Regulation). The implementation of procedures and guidelines appropriate to the airspace structure reduces the collision risk for all aircraft. For instance, there are equipment requirements established for the airspace requested and requirements associated with day-night operations, pilot training, airworthiness, lighting requirements, altimetry requirements, airspace restrictions, altitude restrictions, etc. These rules must still be addressed by the competent authority. The Member State is responsible for defining the airspace structures in accordance with

text: Regulation (EU) 2017/373

text: ; in addition, as required in Article 15 of the UAS Regulation, the Member State will define the geographical zones for UAS operators. The Member State, when defining the airspace structure, considers the traffic type and complexity and defines the airspace classes and services being provided in accordance with the SERA. This information, which can be published either in the aeronautical information publication (AIP) or any other aeronautical publication, can be used by the UAS operator to identify the initial air risk. The SORA air risk model is a tool to assess the risks associated with UAS operations in a particular volume of airspace, and a method to determine whether those risks are within acceptable safety limits.

text: C.3.4 Regulatory requirements, safety requirements, and waivers

text: The SERA Regulation requires all aircraft, manned and UAS, to ‘remain well clear from and avoid collisions with’ other manned aircraft. The UAS is unable to ‘see and avoid’, therefore, it must

text: Annex I to ED Decision 2019/021/R

text: employ an alternate means of compliance to meet the intent of ‘see and avoid’, which will have to be defined in terms of safety and performance for the UAS operation. When the risk of an encounter with manned aircraft is extremely low (i.e. in atypical/segregated airspace), an alternate means of compliance may not be required. For example, in areas where the manned airspace density is so low, (e.g. in the case of low-level operations in remote parts of Alaska or northern Sweden), the airspace safety threshold could be met with no additional mitigation. UAS operators need to understand that although the airspace may be technically safe to fly in from an air collision risk standpoint, it does not fulfil point SERA.3201 of the SERARegulation, or the ICAO Annex 2, Section 3.2 ’See and Avoid’ requirements. To operate a UAS in manned airspace, two requirements must be met: (a) A safety requirement that ensures that the operation is safe to conduct in the operational volume; and (b) A requirement for compliance with point SERA.3201 of the SERA Regulation to ‘see and avoid’. These requirements must be addressed to the competent authority through either: (1) demonstration of compliance with both requirements; (2) demonstration of an alternate means of compliance with the requirements; or (3) a waiver of the requirement(s) by the competent authority. The SORA provides a means to assess whether the air risks associated with UAS operations is within acceptable limits.

text: C.3.5 SORA assumptions on threat aircraft

text: This air risk assessment does not consider the ability of the threat aircraft to remain well clear from or to avoid collisions with the UAS in any part of the safety assessment.

text: C.3.6 SORA assumptions on people-carrying UAS

text: This air risk model does not consider the notion of UAS carrying people, or urban mobility operations. The model and the assessment criteria are limited to the risk of an encounter with manned aircraft, i.e. an aircraft piloted by a human on board.

text: C.3.7 SORA assumptions on UAS lethality

text: This air risk assessment assumes that a mid-air collision between a UAS and manned aircraft is catastrophic. Frangibility is not considered.

text: C.3.8 SORA assertion on tactical mitigations

text: The SORA model makes no distinction between separation provision and collision avoidance but treats them as one dependent system performing a continuous function, whose goals and objectives change over time. This continuum starts with an encounter and progresses to a near mid-air collision objective as the pilot and/or the detect and avoid system of the UA negotiate(s) the encounter. The use of the term ‘tactical mitigation’ should therefore not be confused with the provisioning of (tactical) separation services referred to in ICAO Doc 9854.

text: Annex I to ED Decision 2019/021/R

text: C.4 General air-SORA mitigation overview

text: SORA classification of mitigations The SORA classifies mitigations to suit the operational needs of a UAS in the ‘specific’ class. These mitigations are classified as: (a) strategic mitigations by the application of operational restrictions; (b) strategic mitigations by the application of common structures and rules; and (c) tactical mitigations.

text: Figure C.5 shows the alignment of the mitigation definitions between ICAO and the SORA.

text: Annex I to ED Decision 2019/021/R

text: C.5 Air risk strategic mitigation

text: Strategic mitigation consists of procedures and operational restrictions intended to reduce the UAS encounter rates or the time of exposure, prior to take-off. Strategic mitigations are further divided into: (a) mitigations by operational restrictions which are mitigations that are controlled by the UAS operator; and (b) mitigations by common structures and rules which are mitigations which cannot be controlled by the UAS operator.

text: C.5.1 Strategic mitigation by operational restrictions

text: Operational restrictions are controlled by the UAS operator and are intended to mitigate the risk of a collision prior to take-off. This section provides details on operational restrictions, and examples of how these can be applied to UAS operations. Operational restrictions are the primary means that a UAS operator can apply to reduce the risk of collision using strategic mitigation(s). The most common mitigations by operational restriction are: (a) mitigation(s) that bound the geographical volume in which the UAS operates (e.g. certain boundaries or airspace volumes); and (b) mitigation(s) that bound the operational time frame (e.g. restricted to certain times of day, such as flying only at night). In addition to the above, another approach to limit exposure to risk is to limit the exposure time. This is called ‘mitigation by exposure’. Mitigation by exposure simply limits the time of exposure to the operational risk. Mitigations that limit the flight time or the exposure time to risk may be more difficult to apply. With this said, there is some precedence for this mitigation, which has (in some cases) been accepted by the competent authority. Therefore, even though it is considered to be difficult, this mitigation strategy may be considered. One example is the minimum equipment list (MEL) system, which allows, in certain situations, a commercial airline to fly for three to ten days with an inoperative traffic collision avoidance system (TCAS). The safety argument is that three days is a very short exposure time compared with the total life-time risk exposure of the aircraft. This short time of elevated risk exposure is justified to allow the aircraft to return to a location where proper equipment maintenance can take place. While appreciating that this may be a difficult argument for the UAS operation to make, the UAS operator is still free to pursue this line of reasoning for a reduction in the risk of collision by applying a time of exposure argument.

text: C.5.1.1. Example of operational restriction by geographical boundary

text: Annex I to ED Decision 2019/021/R

text: The UAS operator intends to fly in a Class B airport airspace. The Class B airspace, as a whole, has a very high encounter rate. However, the UAS operator wishes to operate at a very low altitude and at the very outer reaches of the Class B airspace where manned aircraft do not routinely fly. The UAS operator draws up a new operational volume at the outer edge of the class B airspace and demonstrates that operations within the new Class B volume have very low encounter rates. The UAS operator may approach this scenario by requesting the competent authority to more precisely define the airport environment from the SORA perspective. The UAS operator then considers the newly defined airport environment, and provides an operational restriction that allows the UAS operation to safely remain inside the class B airspace, but outside the newly defined SORA airport environment.

text: C.5.1.2 Example of operational restriction by time limitations

text: The UAS operator wishes to fly in a Class B airport airspace. The Class B airspace, as a whole, has a very high encounter rate. However, the UAS operator wishes to operate at a time of day when manned aircraft do not routinely fly. The UAS operator then restricts the time schedule of the UAS operation and demonstrates that the new time (e.g. 03:00 / 3 AM and still within Class B) has very low encounter rates and is safe for operation.

text: C.5.1.3 Example of operational restriction by time of exposure

text: The UAS operator wishes to cut the corner of a Class B airspace for flight efficiency. The UAS operator demonstrates that even though the Class B airspace has a high encounter rate, the UAS is only exposed to that higher rate for a very short amount of time as it transitions the corner.

text: C.5.2 Strategic mitigation by common structures and rules

text: Strategic mitigation by common structures and rules requires all aircraft within a certain class of airspace to follow the same structures and rules; these structures and rules work to lower the risk of collision within the airspace. In accordance with the SERA Regulation, all aircraft in that airspace must participate, and only the competent authorities have the authority to set requirements for those aircraft, while the ANSP and ATCO provide instructions. The UAS operator does not have control over the existence or level of participation of the airspace structure or the application of the flight rules. Therefore, strategic mitigation by common structures and rules is applied by the competent authorities. These should be made available to the UAS operator through the geographical zones, defined in accordance with Article 15 of the UAS Regulation. For example, imagine the situation if individual drivers could create their own driving rules to cover their direction, lanes, boundaries and speed. If the driving rules were different from one driver to another, no safety benefit would be gained, even though they were all following rules (their own), and total chaos would ensue. However, if all drivers were compelled to follow the

text: Annex I to ED Decision 2019/021/R

text: same set of rules, then the traffic flow would be orderly, with increased safety for all drivers. This is why a UAS operator cannot propose a mitigation schema requiring participation from other airspace users that differs from that required by the competent authority. Most strategic mitigations by common structures and rules will take the form of: (a) common flight rules; and (b) common airspace structures. Strategic mitigations by common flight rules is accomplished by setting a common set of rules which all airspace users must comply with. These rules reduce air conflicts and/or make conflict resolution easier. Examples of common flight rules that reduce the collision risk include right of way rules, implicit and explicit coordination schemes, conspicuity requirements, cooperative identification system, etc. Strategic mitigation by using a common airspace structure is accomplished by controlling the airspace infrastructure through physical characteristics, procedures, and techniques that reduce conflicts or make conflict resolution easier. Examples of common flight airspace structures which reduce the risk of collision are airways, departure and approach procedures, airflow management, etc. In the future, as U-space structures and rules become more readily defined and adopted, they will provide a source for the strategic mitigation of UAS operations by common structures and rules that UAS operators could more easily apply.

text: C.5.2.1 Example of mitigation by common flight rules

text: The UAS operator intends to fly in a volume of airspace in which the competent authority requires all UAS to be equipped with an electronic cooperative system and anti-collision lighting. The rules further require the UAS operator to file a flight plan with the designated ANSP/U-space service providers, and check for potential hazards along the whole flight route. The operator complies with these requirements and installs anti-collision lights and a Mode-S Transponder. The operator further agrees to file a flight plan prior to each flight. These rules enhance the safety of the flight in the same way as a notice to airmen (NOTAM). The UAS operator should also have a system in place to check for high airspace usage in the intended operational volume (e.g. a glider competition or a fly-in). In those situations where the UAS operator does not own the airspace in which the operational volume exists, the rules require the UAS operator to request permission prior to entering that airspace.

text: C.5.2.2. Examples of mitigation by common airspace structure

text: Example 1: The competent authority establishes a transit corridor through Class B airspace that keeps the UAS separated from other non-UAS airport traffic, and safely separates the corridor traffic in one direction from the traffic in the other direction. The UAS operator intends to fly

text: Annex I to ED Decision 2019/021/R

text: through this Class B airport airspace, and hence must stay within the established transit corridor and adhere to the transit corridor rules. Example 2: The UAS operator intends to fly a UAS from one location to another, and files a flight plan with a U-space service provider or the procedural separation system. As the UAS takes off, the U-space service provider then guarantees separation by procedural control of all the aircraft in the airspace. Procedural controls are the take-off windows, reporting points, assigned airways and altitudes, route clearances, etc. required for safe operation.

text: C.6 Reducing the initial air risk class (ARC) assignment (optional)

text: This section is intended for an applicant that intends to use strategic mitigations to reduce the collision risk (i.e. ARC). There are two types of ARC: (a) the initial ARC, which is a qualitative classification of a UAS operational collision risk within an operational volume before strategic mitigations are applied; and (b) the residual ARC, which is a qualitative classification of a UAS operational collision risk in an operational volume after all strategic mitigations are applied. If a UAS operator agrees that the (generalised) initial ARC applicable to their operation and operational volume is correct, then this step is not necessary, and the assessment should continue at SORA Step #6 (assigning the DAA tactical performance requirement and robustness levels based on the residual collision risk). If mitigations to reduce the ARC are relevant and are proposed, this section provides information and examples of how to use strategic mitigation(s) to lower the collision risk within the operational volume, and demonstrate the strategy to a competent authority. The examples within the SORA may or may not be applicable or acceptable to the competent authority; however, the SORA encourages an open dialogue between the applicant and the competent authority to determine what is acceptable evidence.

text: C.6.1 Lowering the initial ARC to the residual ARC-a in any operational volume (optional)

text: ARC-a is intended for operations in atypical/segregated airspace (see Table C.1). Lowering the initial ARC to residual ARC-a requires a higher level of safety verification because it allows a UAS operator to operate without any tactical mitigation. To demonstrate that an operation could be reduced to a residual ARC-a, the UAS operator should demonstrate: (a) that the operational volume can meet the requirements of SORA atypical/segregated airspace; and (b) compliance with any other requirements mandated by the competent authority for the intended operational volume. A residual ARC-a assessment does necessarily exempt the UAS operator from the requirements to ‘see and avoid’ and to ‘remain well clear from’ other aircraft. If the designated competent authority allows the UAS operator a residual ARC-a assessment for the operational volume, in order to comply with the SERA Regulation, the UAS operator must either provide a valid means and equipment as an alternate means of compliance for the ‘see and avoid’ requirement, or the competent authority must waive the requirement to ‘see and avoid’ and ‘remain well clear.’

text: Annex I to ED Decision 2019/021/R

text: C.6.2 Lowering the initial ARC using operational restrictions (optional)

text: There may be many methods by which a UAS operator may wish to demonstrate a suitable air risk and strategic mitigations. The SORA does not dictate how this is achieved, and instead, allows the applicant to propose and demonstrate the suitability and effectiveness of their strategic mitigations. It is important for both the UAS operator and the competent authority to understand that the assessment may be qualitative in nature, and where possible, augmented with quantitative data to support the qualitative assumptions and decisions. The UAS operator and the competent authority should understand there may not be a clear delineation of the decision points, so common sense and the safety of manned aircraft should be of paramount consideration. The SORA provides a two-step method to reduce the air risk by operational mitigation. The first step is to determine the initial ARC by using the potential air risk encounter rate based on known airspace densities (as per Table C.1). The second step is to reduce the initial risk through UAS operator-provided evidence that demonstrates that the intended operation is more indicative of another airspace volume and an encounter rate that corresponds to a lower risk classification (ARC); hence, reducing the initial ARC to a residual ARC (as per Table C.2). This requires the agreement of the competent authority before the ARC may be reduced. The SORA used expertise from subject matter experts to rate the airspace encounter category (AEC) and the variables that influence the encounter rates (i.e. proximity, geometry, and dynamics). The variables are not interdependent, nor do they influence the encounter outcome in the same manner. A small increase in one encounter rate variable can have major effects on the collision risk; conversely, a small increase in another variable could have limited effect on the collision risk. Hence, lowering the aircraft density of an AEC airspace does not equate to a direct and equal lowering of the ARC risk level. There is no direct correlation between an individual AEC variable and the ARC collision risk levels. In summary: (a) there are three inter-dependent variables that affect the ARC; (b) the contribution of each variable to the total collision risk is not the same; and (c) for simplicity, the SORA only allows the manipulation of one of the variables: the proximity, i.e. the aircraft density. The first step to potentially lowering the ARC is to determine the AEC and the associated density rating using Table C.1. 12 operational/airspace environments were considered for the SORA air risk classification, and they correspond to the 12 scenarios found in Figure 4 of the SORA main body.

text: Annex I to ED Decision 2019/021/R

text: Table C.1 – Initial air risk category assessment

text: After determining the initial risk using Table C.1, an applicant may choose to reduce that risk using Table C.2. To understand Table C.2, the first column shows the AEC in the environment in which the UAS operator wishes to operate. Column A shows the associated airspace density rating for that AEC rated from 5 to 1, with 5 being very high density, and 1 being very low density.

text: Column B shows the corresponding initial ARC.

text: Annex I to ED Decision 2019/021/R

text: Column C is key to lowering the initial ARC. This column shows the relative density ratings that a UAS operator should demonstrate to the competent authority in order to argue and justify that the actual local air density rating of the operational area is lower than the rating associated with the initial AEC (Column A) in Table C.1. If this can be shown and accepted by the competent authority, then the new lower ARC level as shown in column D may be applicable. As stated earlier, the UAS operator is responsible for collecting and analysing the airspace density and for demonstrating the effectiveness of their proposal for strategic mitigations by operational restrictions to the competent authority. In summary, the UAS operator should demonstrate that the restrictions imposed on the UAS operation can lower the risk of a collision by showing that the local airspace encounter rate, under the operational restrictions, is lower than the generalised AEC assessed encounter rate provided in Table C.1. The strategic mitigation reduction case should be modelled after a safety case. The size and complexity of the strategic mitigation reduction depends entirely on what the UAS operator is trying to do, and where/when they want to do it. The strategic mitigation case as a safety case has two advantages. Firstly, it provides the UAS operator with a structured approach to describe and capture the operation, the hazards identified, the risk analysed, and the threat(s) mitigated. Secondly, it provides a safety case structure that a competent authority is familiar with, which, in turn, helps the competent authority to understand the UAS operator's intended operation and their reasoning as to why a reduction in the ARC can be safely justified. As each authority is different, the SORA recommends the applicant to contact the competent authority and/or ANSP to determine the format and presentation of the strategic mitigation reduction case.

text: Annex I to ED Decision 2019/021/R

text: To fully understand the above, the SORA provides three examples.

text: Example 1:

text: A UAS operator is intending to operate in an airport/heliport environment, in class C airspace, which corresponds to AEC 1.

text: The UAS operator enters the initial ARC reduction table at Row AEC 1. Column A shows that the generalised airspace density of this environment is 5. Column B shows the associated initial ARC as ARC-d. Column C indicates that if a UAS operator can demonstrate that the actual, local airspace density corresponds to a generalised density rating of 3 or 4, then the ARC level may be reduced to a residual ARC-c (Column D). If a UAS operator demonstrates that the local airspace density corresponds more to scenarios with a density of 2 or 1, then the ARC level may be lowered to a residual ARC-b (Column D).

text: Example 2:

text: A UAS operator is intending to operate in an airport/heliport environment, in class G airspace, with a corresponding level of AEC 6.

text: The UAS operator enters the initial ARC reduction table at Row AEC 6. Column A shows that the generalised airspace density rating that corresponds with this environment is 3. Column B shows the associated initial ARC as ARC-c. Column C indicates that if a UAS operator can demonstrate that the actual, local, airspace density corresponds more to the reference scenario that has a generalised density rating of 1, namely AEC 10, then the residual ARC level may be reduced to ARC-b (Column D).

text: Example 3:

text: Annex I to ED Decision 2019/021/R

text: A UAS operator is intending to operate below 400 ft AGL, in a class G (uncontrolled) airspace, over an urbanised area, with a corresponding level of AEC 9. The UAS operator enters the initial ARC reduction table at Row AEC 9. Column A indicates that the generalised airspace density rating corresponding with this environment is 2. Column B shows the associated initial ARC is ARC-c. Column C indicates that if a UAS operator demonstrates that the local airspace density corresponds more to a density rating of 1, namely AEC 10, then the residual ARC level may be reduced to ARC-b (Column D).

text: C.6.3 Lowering the initial ARC by common structures and rules (optional)

text: Today, aviation airspace rules and structures mitigate the risk of collision. As the airspace risk increases, more structures and rules are implemented to reduce the risk. In general, the higher the aircraft density, the higher the collision risk, and the more structures and rules are required to reduce the collision risk. In general, manned aircraft do not use very low level (VLL) airspace, as it is below the minimum safe height to perform an emergency procedure, ‘unless at such a height as will permit, in the event of an emergency arising, a landing to be made without undue hazard to persons or property on the surface’ (Ref. point SERA.3105 of the SERA Regulation). Subject to permission from the competent authority, special flights may be granted permission to use this airspace. Every aircraft will cross VLL airspace in an airport environment for take-off and landing. With the advent of UAS operations, VLL airspace is expected to soon become more crowded, requiring more common structures and rules to lower the collision risk. It is anticipated that Uspace services will provide these risk mitigation measures. This will require mandatory participation by all aircraft in that airspace, similar to how the current flight rules apply to all manned aircraft operating in a particular airspace today. The SORA does not allow the initial ARC to be lowered through strategic mitigation by common structures and rules for all operations in AEC 1, 2, 3, 4, 5, and 11. Outside the scope of the SORA, a UAS operator may appeal to the competent authority to lower the ARC by strategic mitigation by using common structures. The determination of acceptability falls under the normal airspace rules, regulations and safety requirements for ATM/ANS providers. Similarly, the SORA does not allow for lowering the initial ARC through strategic mitigation by using common structures and rules for all operations in AEC 10 . The maximum amount of ARC reduction through strategic mitigation by using common structures and rules is by one ARC level.

text: Annex I to ED Decision 2019/021/R

text: The SORA does allow for lowering the initial ARC through strategic mitigation by structures and rules for all operations below 400 ft AGL within VLL airspace (AECs 7, 8, 9 and 10). To claim an ARC reduction, the UAS operator should show the following: (a) the UA is equipped with an electronic cooperative system, and navigation and anticollision lighting ; (b) a procedure has been implemented to verify the presence of other traffic during the UAS flight operation (e.g. checking other aircraft’s filed flight plans, NOTAMs , etc.); (c) a procedure has been implemented to notify other airspace users of the planned UAS operation (e.g. filing of the UAS flight plan, applying for a NOTAM from the service provider for UAS operations, etc.); (d) permission has been obtained from the airspace owner to operate in that airspace (if applicable); (e) compliance with the airspace UAS flight rules, the UAS Regulation, and the policies, etc. applicable to the UAS operational volume and with which all/most aircraft are required to comply (these flight rules, the UAS Regulation, and policies are aimed primarily at UAS operations in VLL airspace); (f) a UAS airspace structure (e.g. U-space) exists in VLL airspace to help keep UAS separated from manned aircraft. This structure must be complied with by all UAS in accordance with the EU or national regulations; (g) a UAS airspace procedural separation service has been implemented for VLL airspace. The use of this service must be mandatory for all UAS to keep UAS separated from manned aircraft in accordance with the SERA Regulation; and (h) all UAS operators can directly communicate with the air traffic controller or flight information services directly or through a U-space service provider in accordance with the SERA Regulation (EU).

text: C.6.3.1 Demonstration of strategic mitigation by structures and rules

text: Annex I to ED Decision 2019/021/R

text: The UAS operator is responsible for collecting and analysing the data required to demonstrate the effectiveness of their strategic mitigations by structures and rules to the competent authority.

text: C.7 Determination of the residual ARC risk level by the competent authority

text: As stated before, the UAS operator is responsible for collecting and analysing the data required to demonstrate the effectiveness of all their strategic mitigations to the competent authority. The competent authority makes the final determination of the airspace residual ARC level. Caution: As the SORA breaks down collision mitigation into strategic and tactical parts, there can be some overlap between all these mitigations. The UAS operator and the competent authority need to be cognisant and to ensure that mitigations are not counted twice. Although the static generalised risk (i.e. ARC) is conservative, there may be situations where that conservative assessment may be insufficient. In those situations, the competent authority may raise the ARC to a level that is higher than that advocated by the SORA. For example, a UAS operator surveys a forest near an airport for beetle infestation, and the airspace was assessed as being ARC-b. The airport is hosting an air show. The competent authority informs the UAS operator that during the week of the air show, the ARC for that local airspace will be ARC-d. The UAS operator can either equip for ARC-d airspace or suspend operations until the air show is over.

text: Annex I to ED Decision 2019/021/R

text: ANNEX D TO APPENDIX A TO AMC1 TO ARTICLE 11

text: TACTICAL MITIGATION COLLISION RISK ASSESSMENT

text: D.1 Introduction-tactical mitigation

text: The target audience for Annex D is the UAS operator who wishes to apply TMPR, robustness, integrity, and assurance levels for their operation. Annex D provides the tactical mitigation(s) used to reduce the risk of a mid-air collision. The TMPR is driven by the residual collision risk of the airspace. Some of these tactical mitigations may also provide means of compliance with point SERA.3201 of the SERA Regulation, and the additional requirements of various states. The air-risk model has been developed to provide a holistic method to assess the risk of an air encounter, and to mitigate the risk that an encounter develops into a mid-air collision. The SORA air-risk model guides the UAS operator, the competent authority, and/or ANSP in determining whether an operation can be conducted in a safe manner. This Annex is not intended to be used as a checklist, nor does it provide answers to all the challenges of DAA. The guidance allows a UAS operator to determine and apply a suitable means of mitigation to reduce the risk of a midair collision to an acceptable level. This guidance does not contain prescriptive requirements, but rather objectives to be met at various levels of robustness.

text: D.2 Principles

text: The mitigation of the risk that an encounter develops into a mid-air collision is a highly dynamic, variable, and complicated process. To simplify the process, the air-risk model takes a more qualitative approach to arrive at an initial aggregated airspace risk assessment. After an assessment of the initial, unmitigated risk of an encounter, and optional application of strategic mitigations, this Annex assigns a performance requirement on the UAS operation to mitigate the remaining collision hazard (i.e. the residual airspace risk).

text: D.3 Scope, assumptions and definitions

text: See Annex C for the scope and assumptions

text: D.4 Knowledge of terms and definitions

text: To understand this section, the following SORA definitions need to be understood: (a) atypical/segregated vs other airspace; (b) AEC (see Annex C); (c) initial ARC (see Annex C); (d) residual ARC (see Annex C); (e) ICAO conflict management (see ICAO Doc 9854, Section 2.7); (f) strategic mitigation (see Annex C); (g) tactical mitigations and feedback loops; and (h) VLOS and BVLOS.

text: Annex I to ED Decision 2019/021/R

text: D.5 TMPR assignment

text: A tactical mitigation is a mitigation applied after take-off, and for the air risk model, it takes the form of a ‘mitigating feedback loop’. This feedback loop is dynamic in that it reduces the rate of collision by modifying the geometry and dynamics of the aircraft in conflict, based on real-time aircraft conflict information. SORA tactical mitigations are applied to cover the gap between the residual risk of an encounter (the residual ARC) and the airspace safety objectives. The residual risk is the remaining collision risk after all strategic mitigations are applied.

text: D.5.1 Two classifications of tactical mitigation

text: There are two classifications of tactical mitigations within the SORA, namely: (a) VLOS, whereby a pilot and/or observer uses (use) human vision to detect aircraft and take action to remain well clear from and avoid collisions with other aircraft. (b) BVLOS, whereby an alternate means of mitigation to human vision, as in machine or machine assistance , is applied to remain well clear from and avoid collisions with other aircraft (e.g. ATC separation services, TCAS, DAA, U-space, etc.).

text: D.5.2 TMPR using VLOS

text: Originally the regulations for ‘see and avoid’ and ‘avoid collisions’, defined in point SERA.3201 of the SERA Regulation, assumed that a pilot was on board the aircraft. With UA, this assumption is no longer valid, as the aircraft is piloted remotely. Under VLOS, the pilot/UAS operator accomplishes ‘see and avoid’ by keeping the UAS within their VLOS. The UAS remains close enough to the remote pilot/observer to allow them to see and avoid another aircraft with human vision unaided by any device other than, perhaps, corrective lenses. VLOS is generally considered an acceptable means of compliance with the ‘remain well clear from’ and ‘avoiding collisions’ requirements of point SERA.3201 of the SERA Regulation. VLOS generally provides sufficient mitigation for cases where the requirements for tactical mitigations are low, medium, and high. Different states may have other rules and restrictions for VLOS operations (e.g. altitudes, horizontal distances, times for relaying critical flight information, UAS operator/observer training, etc.). In some situations, the competent authority may decide that VLOS does not provide sufficient mitigation for the airspace risk, and may require compliance with additional rules and/or requirements. It is the UAS operators’ responsibility to comply with these rules and requirements. The UAS operator should produce a documented VLOS de-confliction scheme, explaining the methods that will be applied for detection and the criteria used to avoid incoming traffic. If the remote pilot relies on detection by observers, the use of communication phraseology, procedures, and protocols should be described. Since the VLOS operation may be sufficiently

text: Annex I to ED Decision 2019/021/R

text: complex, a requirement to document and approve the VLOS strategy is necessary before approval by the competent authority. The use of VLOS as a mitigation does not exempt the UAS operator from performing the full SORA risk analysis.

text: D.5.3 TMPR using BVLOS

text: Since VLOS has operational limitations, there was a concerted effort to find an alternate means of compliance with the human ‘see and avoid’ requirements. This alternate means of mitigation is loosely described as ‘detect and avoid (DAA)’. DAA can be achieved in several ways, e.g. through ground-based DAA systems, air-based DAA systems, or some combination of the two. DAA may incorporate the use of various sensors, architectures, and even involve many different systems, a human in the loop, on the loop, or no human involvement at all. TMPR provides tactical mitigations to assist the pilot in detecting and avoiding traffic under BVLOS conditions. The TMPR is the amount of tactical mitigation required to further mitigate the risks that could not be mitigated through strategic mitigation (the residual risk). The amount of residual risk is dependent on the ARC. Hence, the higher the ARC, the greater the residual risk, and the greater the TMPR. Since the TMPR is the total performance required by all tactical mitigation means, tactical mitigations may be combined. When combining multiple tactical mitigations, it is important to recognise that the mitigation means may interact with each other, depending on the level of interdependency. This may negatively affect the effectiveness of the overall mitigation. Care should be exercised not to underestimate the negative effects of interactions between mitigation systems. Regardless of whether mitigations or systems are dependent or independent, when they act on the same event, unintended consequences may occur.

text: D.5.3.1 TMPR assignment risk ratio

text: The SORA TMPR is based on the findings of several studies. These studies provide performance guidance using risk ratios. Table shows the SORA TMPR risk ratio requirements derived from those studies.

text: Air-Risk TMPR TMPR system risk ratio objectives Class

text: ARC-d high performance system risk ratio ≤ 0.1

text: medium ARC-c system risk ratio ≤ 0.33 performance

text: ARC-b low performance system risk ratio ≤ 0.66

text: No system risk ratio guidance; although the UAS No performance operator/applicant may still need to show some form of ARC-a requirement mitigation as deemed necessary by the competent authority

text: Annex I to ED Decision 2019/021/R

text: Table provides TMPR qualitative criteria as a qualitative means of compliance to help UAS operators translate the risk ratio quantitative values found in Table D.1 into system qualitative functional requirements. Table D.3 provides guidance for the TMPR integrity and assurance objectives for compliance with the objectives of Table C.1. For the purpose of this assessment, the objectives of Table D.1 take precedence over the guidance provided in Tables D.2 and D.3.

text: D.5.3.2 TMPR qualitative criterion table

text: Table D.2, below, shows more qualitative criteria for the different functions and levels of the TMPR. The qualitative criteria are divided into five sub-functions of DAA, namely: detect, decide, command, execute, and the feedback loop. Where reference is made to the detection of a percentage of all aircraft, this should be read as a detection rate of the overall mix of aircraft anticipated to be encountered in the detection volume, and not limited to the detection of just the subset of aircraft in the mix.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: D.5.3.3 Effects of aircraft equipment on tactical system performance

text: The performance of a tactical mitigation is affected by the equipment of both the UAS and threat aircraft, on an encounter-by-encounter basis. A tactical mitigation mitigates the encounter risk by using a set of sub-functions of the DAA routine, namely see/detect, decide, command, execute, and feedback loop. Equipment that aids these sub-functions increases the overall performance of the tactical mitigation system.

text: Annex I to ED Decision 2019/021/R

text: The following example illustrates how the equipment of both the UAS and threat aircraft affects the overall tactical performance. Given a threat aircraft equipped with a transponder, it is easier for other aircraft to detect and track the threat aircraft. In this case, the UAS can be equipped with a system that is able to detect and track transponders. However, a UAS that mitigates the risk by locating the threat aircraft by detecting their transponder (e.g. through ACAS-II V. 7.1) cannot use the same approach to mitigate the risks posed by an aircraft without a transponder. Tactical mitigation equipment is not homogeneous within the airspace. Different classes of airspace have different mixes of equipment. General aviation aircraft tend to be less wellequipped than commercial aircraft. There will be differences in the mix of general aviation/commercial aircraft from one location/airspace to another. Based on the aircraft equipment, a specific tactical system (e.g. FLARM, ACAS, etc.) could mitigate the risk of a collision in some classes of airspace and not in others. Therefore, the UAS operator needs to understand the effectiveness of their tactical mitigation systems within the context of the airspace in which they intend to operate, and select systems used for tactical mitigation accordingly. A TCAS II 7.1/ACAS-II equipped UAS will not mitigate all the encounter risks in an area where sailplanes equipped with FLARM are known to operate.

text: D.5.4. TMPR robustness (integrity and assurance) assignment

text: Table D.3, below, lists the recommended requirements to comply with the TMPR integrity and assurance assignment.

text: Annex I to ED Decision 2019/021/R

text: D.6 Maintenance and continued airworthiness

text: The DAA maintenance and continued airworthiness requirements are addressed in the SAIL requirements; please refer to Annex E.

text: Annex I to ED Decision 2019/021/R

text: ANNEX E TO APPENDIX A TO AMC1 TO ARTICLE 11

text: INTEGRITY AND ASSURANCE LEVELS FOR THE OPERATIONAL SAFETY OBJECTIVES (OSOs)

text: E.1 How to use SORA Annex E

text: The following Table E.1 provides the basic principles to consider when using SORA Annex E.

text: Annex I to ED Decision 2019/021/R

text: E.2 OSOs related to technical issues with the UAS

text: OSO #01 — Ensure that the UAS operator is competent and/or proven

text: OSO #02 — UAS designed and produced by a competent and/or proven entity

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #03 — UAS maintained by competent and/or proven entity

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #04 — UAS developed to authority recognised design standards

text: Annex I to ED Decision 2019/021/R

text: OSO #05 — UAS is designed considering system safety and reliability

text: This OSO complements:

text: (a) the safety requirements for containment defined in the main body; and

text: (b) OSO #10 and OSO #12, which only address the risk of a fatality while operating over populated areas or assemblies of people.

text: Annex I to ED Decision 2019/021/R

text: OSO #06 — C3 link characteristics (e.g. performance, spectrum use) are appropriate for the operation

text: (a) For the purpose of the SORA and this specific OSO, the term ‘C3 link’ encompasses:

text: (1) the C2 link; and

text: (2) any communication link required for the safety of the flight.

text: (b) To correctly assess the integrity of this OSO, the applicant should identify the following:

text: (1) The performance requirements for the C3 links necessary for the intended operation.

text: Annex I to ED Decision 2019/021/R

text: (2) All the C3 links, together with their actual performance and RF spectrum usage. Note: The specification of the performance and RF spectrum for a C2 Link is typically documented by the UAS designer in the UAS manual. Note: The main parameters associated with the performance of a C2 link (RLP) and the performance parameters for other communication links (e.g. RCP for communication with ATC) include, but are not limited to, the following: (i) the transaction expiration time; (ii) the availability; (iii) the continuity; and (iv) the integrity. Refer to the ICAO references for definitions. (3) The RF spectrum usage requirements for the intended operation (including the need for authorisation if required). Note: Usually, countries publish the allocation of RF spectrum bands applicable in their territories. This allocation stems mostly from the International Communication Union (ITU) Radio Regulations. However, the applicant should check the local requirements and request authorisation when needed since there may be national differences and specific allocations (e.g. national sub-divisions of ITU allocations). Some aeronautical bands (e.g. AM(R)S, AMS(R)S 5030-5091MHz) were allocated for potential use in UAS operations under the ICAO scope for UAS operations classified as cat. C (‘certified’), but their use may be authorised for operations under the ‘specific’ category. It is expected that the use of other licensed bands (e.g. those allocated to mobile networks) may also be authorised under the ‘specific’ category. Some un-licensed bands (e.g. industrial, scientific and medical (ISM) or short-range devices (SRDs)) may also be acceptable under the ‘specific’ category; for instance, for operations with lower integrity requirements. (4) Environmental conditions that might affect the performance of C3 links.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #07 — Inspection of the UAS (product inspection) to ensure consistency with the ConOps

text: The intent of this OSO is to ensure that the UAS used for the operation conforms to the UAS data used to support the approval/authorisation of the operation.

text: Annex I to ED Decision 2019/021/R

text: E.3 OSOs related to operational procedures

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: E.4 OSOs related to remote crew training

text: (a) The applicant needs to propose competency-based, theoretical and practical training that:

text: (1) is appropriate for the operation to be approved; and

text: (2) includes proficiency requirements and recurrent training.

text: (b) The entire remote crew (i.e. any person involved in the operation) should undergo competency-based, theoretical and practical training specific to their duties (e.g. pre-flight inspection, ground equipment handling, evaluation of the meteorological conditions, etc.).

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: E.5 OSOs related to safe design

text: (a) The objectives of OSO#10 and OSO#12 are to complement the technical containment safety requirements by addressing the risk of a fatality while operating over populated areas or assemblies of people.

text: (b) In the scope of this assessment, external systems supporting UAS operations are defined as systems that are not already part of the UAS but are used to:

text: (1) launch/take off the UA;

text: (2) make pre-flight checks; or

text: (3) keep the UA within its operational volume (e.g. GNSS, satellite systems, air traffic management, U-space).

text: External systems activated/used after a loss of control of the operation are excluded from this definition.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: E.6 OSOs related to the deterioration of external systems supporting UAS operations

text: For the purpose of the SORA and this specific OSO, the term ‘external services supporting UAS operations’ encompasses any service providers necessary for the safety of the flight, such as communication service providers (CSPs) and U-space service providers.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: E.7 OSOs related to Human Error

text: OSO #16 — Multi-crew coordination

text: This OSO applies only to those personnel directly involved in the flight operation.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #17 — Remote crew is fit to operate

text: (a) For the purpose of this assessment, the expression ‘fit to operate’ should be interpreted as physically and mentally fit to perform their duties and safely discharge their responsibilities.

text: (b) Fatigue and stress are contributory factors to human error. Therefore, to ensure that vigilance is maintained at a satisfactory level of safety, consideration may be given to the following:

text: (1) remote crew duty times;

text: (2) regular breaks;

text: (3) rest periods; and

text: (4) handover/takeover procedures.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #18 — Automatic protection of the flight envelope from human errors

text: (a) Each UA is designed with a flight envelope that describes its safe performance limits with regard to minimum and maximum operating speeds, and its operating structural strength.

text: (b) Automatic protection of the flight envelope is intended to prevent the remote pilot from operating the UA outside its flight envelope. If the applicant demonstrates that the remote-pilot is not in the loop, this OSO is not applicable.

text: (c) A UAS implementing such an automatic protection function will ensure that the UA is operated within an acceptable flight envelope margin even in the case of incorrect remote-pilot control inputs (human errors).

text: (d) UAS without automatic protection functions are susceptible to incorrect remote-pilot control inputs (human errors), which can result in the loss of the UA if the designed performance limits of the aircraft are exceeded.

text: (e) Failures or development errors of the flight envelope protection are addressed in OSOs #5, #10 and #12.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #19 — Safe recovery from human errors

text: (a) This OSO addresses the risk of human errors which may affect the safety of the operation if not prevented or detected and recovered in a timely fashion.

text: i) Errors can be made by anyone involved in the operation.

text: ii) An example could be a human error leading to the incorrect loading of the payload, with the risk of it falling off the UA during the operation.

text: iii) Another example could be a human error not to extend the antenna mast, thus reducing the C2 link coverage.

text: Note: the flight envelope protection is excluded from this OSO since it is specifically covered by OSO #18.

text: (b) This OSO covers:

text: i) procedures and lists,

text: ii) training, and

text: iii) UAS design, i.e. systems detecting and/or recovering from human errors (e.g. safety pins, use of acknowledgment features, fuel or energy consumption monitoring functions …)

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #20 — A Human Factors evaluation has been performed and the HMI found appropriate for the mission

text: Annex I to ED Decision 2019/021/R

text: E.8 OSOs related to Adverse Operating Conditions

text: OSO #23 — Environmental conditions for safe operations are defined, measurable and adhered to

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: OSO #24 — UAS is designed and qualified for adverse environmental conditions (e.g. adequate sensors, DO-160 qualification) (a) To assess the integrity of this OSO, the applicant determines: (1) whether credit can be taken for the equipment environmental qualification tests / declarations, e.g. by answering the following questions: (i) Is there a Declaration of Design and Performance (DDP) available to the applicant stating the environmental qualification levels to which the equipment was tested? (ii) Did the environmental qualification tests follow a standard considered adequate by the competent authority (e.g. DO-160)? (iii) Are the environmental qualification tests appropriate and sufficient to cover all the environmental conditions related to the ConOps? (iv) If the tests were not performed following a recognised standard, were the tests performed by an organisation/entity that is qualified or that has experience in performing DO-160 like tests? (2) Can the suitability of the equipment for the intended/expected UAS environmental conditions be determined from either in-service experience or relevant test results? (3) Any limitations which would affect the suitability of the equipment for the intended/expected UAS environmental conditions. (b) The lowest integrity level should be considered for those cases where a UAS equipment has only a partial environmental qualification and/or a partial demonstration by similarity and/or parts with no qualification at all.

text: Annex I to ED Decision 2019/021/R

text: Annex I to ED Decision 2019/021/R

text: E.9 Assurance level criteria for technical OSO

text: Annex II to ED Decision 2019/021/R

text: Article 11

text: PREDEFINED RISK ASSESSMENT PDRA-01 Version 1.0 EDITION September 2019 (a) Scope This PDRA is the result of applying the methodology described in AMC1 to Article 11 of the UAS Regulation to UAS operations performed in the ‘specific’ category with the following main attributes: (1) UA with maximum characteristic dimensions (e.g. wingspan, rotor diameter/area or maximum distance between rotors in case of multirotor) up to 3 m and typical kinetic energies up to 34 kJ; (2) operated BVLOS of the remote pilot with visual air risk mitigation; (3) over sparsely populated areas; (4) less than 150 m (500 ft) above the overflown surface (or any other altitude reference defined by the state); and (5) in uncontrolled airspace. (b) PDRA characterisation and provisions Characterisation and provisions for this PDRA are summarised in Table PDRA-01.1.

text: PDRA characterisation and provisions

text: 1. Operational characterisation (scope and limitations) 1.1 No autonomous operations: the remote pilot should have the ability to control the UA, Level of human except in case of a lost link. intervention 1.2 The remote pilot should only operate one UA at a time. 1.3 The remote pilot should not operate from a moving vehicle. 1.4 Handover between RPSs should not be performed. 1.5 Launch/recovery: VLOS distance from the remote pilot UA range limit 1.6 In flight: 1.6.1 If no VOs are used: UA is not operated at more than 1 km (or other distance defined by the competent authority) from the remote pilot. Note: The remote pilot’s workload should be adequate to allow him or her to continuously scan the airspace. 1.6.2 If VOs are used: the range is not limited as long as the UA is not operated at more than 1 km (unless a different distance is defined by the competent authority) from the VO who is nearest to the UA. Overflown areas 1.7 Sparsely populated areas. 1.8 Maximum characteristic dimension (e.g. wingspan, rotor diameter/area or maximum UA limitations distance between rotors in the case of a multirotor): 3 m 1.9 Typical kinetic energy (as defined in paragraph 2.3.1(k) of AMC1 to Article 11 of the UAS Regulation up to 34 kJ

text: Annex II to ED Decision 2019/021/R

text: 1.10 The maximum height of the operational volume should not be greater than 150 m Flight height limit (500 ft) above the overflown surface (or any other altitude reference defined by the state). Note: In addition to the vertical limit for the operational volume, an air risk buffer is to be considered (see ‘air risk’ under point 3 of this table). 1.11 Operated: Airspace 1.11.1 in uncontrolled airspace (Class F or G) (corresponding to an air risk that can be classified as ARC-b); or 1.11.2 in a segregated area (corresponding to an air risk that can be classified as ARC-a); or 1.11.3 as otherwise established by the Member States in accordance with

text: Article 15

text: (with an associated air risk that can be classified as not higher than ARC-b) 1.12 The UA should be operated in an area where the minimum flight visibility is more Visibility than 5 km. Note: This flight visibility should be understood as the distance that an aircraft can be visually detected by the remote crew. 1.13 The UA should not be used to drop material or carry dangerous goods, except for Others dropping items in connection with agricultural, horticultural or forestry activities in which the carriage of the items does not contravene any other applicable regulations.

text: 2. Operational risk classification (according to the classification defined in AMC1 to Article 11 of the UAS Regulation)

text: Final GRC 3 Final ARC ARC-b SAIL II

text: 3. Operational mitigations

text: 3.1 To determine the operational volume, the applicant should consider the position- Operational volume keeping capabilities of the UAS in 4D space (latitude, longitude, height and time). (see Figure PDRA- 01.1) 3.2 In particular, the accuracy of the navigation solution, the flight technical error of the UAS and the path definition error (e.g. map error) and latencies should be considered and addressed in this determination. 3.3 If the UA leaves the operational volume, emergency procedures should be activated immediately. 3.4 A ground risk buffer should be established to protect third parties on the ground Ground risk outside the operational volume. 3.4.1 The minimum criterion should be the use of the ‘1:1 rule’ (e.g. if the UA is planned to operate at a height of 150 m, the ground risk buffer should at least be 150 m). 3.5 The operational volume and the ground risk buffer should be all contained in a sparsely populated environment. 3.6 The applicant should evaluate the area of operations typically by means of an on-site inspection or appraisal, and should be able to justify a lower density of people at risk.

text: Annex II to ED Decision 2019/021/R

text: Air risk 3.7 An air risk buffer should be defined. 3.8 This air risk buffer should be contained in the F or G airspace class (uncontrolled airspace) over sparsely populated areas and in UAS geographical zones defined by MSs where the probability of encounter with manned aircraft and other airspace users is not low. 3.9 The operational volume should be outside any geographical zone corresponding to a flight restriction zone of a protected aerodrome or of any other type, as defined by the responsible authority, unless the UAS operator is in receipt of the appropriate permission. 3.10 Prior to flight, the proximity of the planned operation to manned aircraft activity should be assessed. VOs 3.11 The remote pilot should determine the correct placement and number of VOs along the intended flight path. Prior to each flight, the UAS operator should check: 3.11.1 the compliance between the visibility and planned range for VOs; 3.11.2 the presence of potential terrain obstructions for VOs; and 3.11.3 that there are no gaps between the zones covered by each of the VOs. 3.12 The VO(s) necessary to safely conduct the operation should be in place during flight operations. Note: The remote pilot may perform the visual scan of the airspace instead of a VO provided that the workload is adequate to perform his or her duties as the remote pilot.

text: 4. Operator provisions

text: Operator 4.1 The UAS operator should: 4.1.1 have knowledge of the UAS being used; and 4.1.2 develop relevant procedures including at least the following as a minimum: operational procedures (e.g. checklists), maintenance, training, responsibilities, and duties. 4.2 The aforementioned aspects should be addressed in the ConOps (see Annex A to AMC1 to Article 11 of the UAS Regulation).

text: Annex II to ED Decision 2019/021/R

text: UAS operations 4.3 The UAS operator should develop an OM (for the template, refer to GM1 UAS.SPEC.030(3)(e)). 4.4 The operational procedures should be validated against standards recognised by the competent authority and/or in accordance with a means of compliance acceptable to that authority. 4.5 The adequacy of the contingency and emergency procedures should be proved through: 4.5.1 dedicated flight tests; or 4.5.2 simulations, provided that the representativeness of the simulation means is proven for the intended purpose with positive results; or 4.5.3 any other means acceptable to the competent authority. 4.6 The UAS operator should develop an ERP (see GM2 UAS.SPEC.030(3)(e)) 4.7 The remote crew should be competent and be authorised by the UAS operator to carry out the intended operations. 4.8 A list of the remote crew members authorised to carry out UAS operations is established and kept up to date. 4.9 A record of all the relevant qualifications, experience and/or training completed by the remote crew is established and kept up to date. 4.10 The applicant should have a policy that defines how the remote crew can declare themselves fit to operate before conducting any operation. UAS maintenance 4.11 The UAS maintenance instructions should be defined by the UAS operator, documented and cover at least the UAS manufacturer’s instructions and requirements when applicable. 4.12 The maintenance staff should be competent and should have received an authorisation from the UAS operator to carry out maintenance. 4.13 The maintenance staff should use the UAS maintenance instructions while performing maintenance. 4.14 The maintenance instructions should be documented. 4.15 The maintenance conducted on the UAS should be recorded in a maintenance log system. 4.16 A list of the maintenance staff authorised to carry out maintenance should be established and kept up to date. 4.17 A record of all the relevant qualifications, experience and/or training completed by the maintenance staff should be established and kept up to date. 4.18 The maintenance log may be requested for inspection/audit by the approving authority or an authorised representative. External services 4.19 The applicant should ensure that the level of performance for any externally provided service necessary for the safety of the flight is adequate for the intended operation. The applicant should declare that this adequate level of performance is achieved. 4.20 The roles and responsibilities between the applicant and the external service provider should be defined.

text: 5. Provisions for the personnel in charge of duties essential to the UAS operation

text: Annex II to ED Decision 2019/021/R

text: As per Appendix A

text: 6. Technical provisions

text: HMI 6.3 The UAS information and control interfaces should be clearly and succinctly presented and should not confuse, cause unreasonable fatigue, or contribute to causing any disturbance to the personnel in charge of duties essential to the UAS operation such that this could adversely affect the safety of the operation. 6.4 If an electronic means is used to support VOs in their role of maintaining awareness of the position of the unmanned aircraft, its HMI should: 6.4.1 be sufficiently easy to understand to allow the VOs to determine the position of the UA during the operation; and 6.4.2 not degrade the VOs’ ability to: 6.4.2.1 perform unaided visual scanning of the airspace where the UA is operating for any potential collision hazard; and 6.4.2.2 maintain effective communication with the remote pilot at all times. 6.5 The applicant should conduct an evaluation of the UAS considering and addressing human factors to determine whether the HMI is appropriate for the mission.

text: C2 links and 6.6 The UAS should comply with the appropriate requirements for radio equipment and communication the use of the RF spectrum. 6.7 Protection mechanisms against interference should be used, especially if unlicensed bands (e.g. ISM) are used for the C2 Link (mechanisms such as FHSS, technology or frequency de-confliction by procedure). 6.8 Communication between the remote pilot and the VO(s) should allow the remote pilot to manoeuvre the UA with sufficient time to avoid any risk of collision with manned aircraft, in accordance with UAS.SPEC.060(3)(b) of the UAS Regulation.

text: Tactical mitigation 6.9 The UAS design should be adequate to ensure that the time required between a command given by the remote pilot and the UA executing it does not exceed 5 seconds. 6.10 Where an electronic means is used to assist the remote pilot and/or VOs in being aware of the UA position in relation to potential ‘airspace intruders’, the information is provided with a latency and an update rate for intruder data (e.g. position, speed, altitude, track) that support the decision criteria.

text: Annex II to ED Decision 2019/021/R

text: Containment 6.11 To ensure a safe recovery from a technical issue involving the UAS or an external system supporting the operation, the UAS operator should ensure: 6.11.1 that no probable failure of the UAS or any external system supporting the operation should lead to operation outside the operational volume. 6.11.2 that it is reasonably expected that a fatality will not occur from any probable failure of the UAS, or any external system supporting the operation. 6.12 The vertical extension of the operational volume should be 150 m above the surface (or any other altitude reference defined by the state). Note: The term ‘probable’ needs to be understood in its qualitative interpretation, i.e. ‘anticipated to occur one or more times during the entire system/operational

text: life of an item.’

text: 6.13 A design and installation appraisal should be made available and should minimally include: 6.13.1 design and installation features (independence, separation and redundancy); 6.13.2 particular risks (e.g. hail, ice, snow, electro-magnetic interference, etc.) relevant to the ConOps. 6.14 The following additional provisions should apply if the adjacent area includes an assembly of people or if the adjacent airspace is classified as ARC-d (in accordance with AMC1 to Article 11 of the UAS Regulation): 6.141 The probability of leaving the operational volume should be less than 10-4/FH. 6.14.2 No single failure of the UAS or any external system supporting the operation should lead to operation outside the ground risk buffer. Note: The term ‘failure’ needs to be understood as an occurrence, which affects the operation of a component, part, or element such that it can no longer function as intended. Errors may cause failures but are not considered to be failures. Some structural or mechanical failures may be excluded from the criterion if it can be shown that these mechanical parts were designed according to aviation industry best practices. 6.16.3 SW and AEH whose development error(s) could directly lead to operations outside the ground risk buffer should be developed to an industry standard or methodology recognised as adequate by the competent authority. Note 1: The proposed additional safety provisions cover both the integrity and assurance levels. Note 2: The proposed additional safety provisions do not imply a systematic need to develop the SW and AEH according to an industry standard or methodology recognised as adequate by the competent authority. For instance, if the UA design includes an independent engine shutdown function which systematically prevents the UA from exiting the ground risk buffer due to single failures or a SW/AEH error of the flight controls, the intent of provisions 6.16.2 and 6.16.3 could be considered to be met. 6.15 Compliance with provisions 6.16.1 and 2 above should be substantiated by analysis and/or test data with supporting evidence.

text: Annex II to ED Decision 2019/021/R

text: APPENDIX A: The personnel in charge of duties essential to the UAS operation The following are provisions applicable to UAS operators in relation to ensuring the proficiency, competency and clear duty assignment to the personnel in charge of duties essential to the UAS operation. UAS operators may decide to expand these requirements as applicable to its operation. A.1 Training and qualifications for the personnel in charge of duties essential to the UAS operation A.1.1 The UAS operator should ensure that all the personnel in charge of duties essential to the UAS operation (i.e. any people involved in the operation) are provided with competency-based theoretical and practical training specific to their duties that consists of the following elements: A.1.1.2 The basic competencies from the competency framework that are necessary for staff to be adequate for the operation, to ensure safe flight, are as follows: A.1.1.2.1 the UAS regulation, A.1.1.2.2 UAS airspace operating principles, A.1.1.2.3 airmanship and aviation safety, A.1.1.2.4 human performance limitations, A.1.1.2.5 meteorology, A.1.1.2.6 navigation/charts, A.1.1.2.7 UA knowledge, A.1.1.2.8 operating procedures, A.1.1.2.9 assignment of tasks to the crew,

text: Annex II to ED Decision 2019/021/R

text: A.1.1.2.10 establishment of step-by-step communications, and A.1.1.2.11 coordination and handover. A.1.1.3 Familiarisation with the ’specific’ category of operations A.1.1.3.1 The training programme should be documented (at least the training syllabus should be available). A.1.1.3.2 Evidence of training should be presented for inspection upon request from the competent authority or authorised representative. A.2. VOs A.2.1 The VO’s main responsibilities should be to: A.2.1.1 perform unaided visual scanning of the airspace where the UA is operating for any potential hazard in the air; A.2.1.2 maintain awareness of the position of the UA through direct visual observation or through assistance provided by an electronic means; and A.2.1.3 alert the remote pilot if a hazard is detected and assist in avoiding or minimising the potential negative effects. A.3 Remote pilot A.3.1 The remote pilot has the authority to cancel or delay any or all flight operations under the following conditions: A.3.1.1 the safety of persons is threatened; or A.3.1.2 property on the ground is threatened; or A.3.1.3 other airspace users are in jeopardy; or A.3.1.4 there is a violation of the terms of this authorisation. A.3.2 If VOs are used, then the remote pilot should ensure that the necessary VOs are available and correctly placed, and that the communications with them can be adequately performed. A.3.3 The remote pilot should ensure that the UA remains clear of clouds, and that the ability of the remote pilot, or one of the VOs, to perform unaided visual scanning of the airspace where the unmanned aircraft is operating for any potential collision hazard is not hampered by clouds. A.4. Multi-crew cooperation (MCC) A.4.1 In applications where MCC might be required, the UAS operator should: A.4.1.1 include procedures to ensure coordination between the remote crew members with robust and effective communication channels. Those procedures should cover as a minimum: A.4.1.1.1 the assignment of tasks to the remote crew members; and A.4.1.1.2 the establishment of step-by-step communication; and A.4.1.2 ensure that the training of the remote crew covers MCC.

text: Annex II to ED Decision 2019/021/R

text: A.5. The remote crew is fit to operate A.5.1 The UAS operator should have a policy defining how the remote crew can declare themselves fit to operate before conducting any operation. A.5.2 The remote crew shall declare that they are fit to operate before conducting any operation based on the policy defined by the UAS operator. A.6. Maintenance staff A.6.1 Any staff member authorised by the UAS operator to perform maintenance activities should have been duly trained regarding the documented maintenance procedures. A.6.2 Evidence of training should be presented for inspection upon request from the competent authority or authorised representative. A.6.3 The UAS operator may declare that the maintenance team has received training regarding the documented maintenance procedures; however, evidence of this training shall be made available upon request from the competent authority or authorised representative.

text: DECLARATION, VERIFICATION AND ACKNOWLEDGEMENT OF RECEIPT (a) The competent authority should establish an online system for the submission of operational declarations, which provides the submitter with an automatic acknowledgement of receipt when the submission has been successful. (b) For a submission to be considered successful, the online system should check that all the required information has been provided. Otherwise, the system should indicate to the submitter which parts of the information still need to be added to complete the submission of the declaration (e.g. fields to be filled in, compliance with requirements or statements to be accepted or acknowledged, etc.). (c) In order to facilitate cross-border operations, the acknowledgement of receipt should be written at least in English, in addition to the language of the Member State. A formula such as the following may be used: ‘The {name of the competent authority} acknowledges the receipt of the declaration submitted by {name of the UAS operator and UAS operator registration number}, on {date of submission of the declaration} related to the STS {identification of the STS}. The declaration has been found to be complete.’

text: Article 13

text: Cross-border operations or operations outside the state of registration

text: GENERAL The picture below illustrates an example of an authorisation, already provided by the competent authority, to conduct an operation in the Member State of registration, which is used to conduct the same operation in another Member State:

text: Annex II to ED Decision 2019/021/R

text: In the example, the UAS operator receives the authorisation from the competent authority of the Member State of registration where the mitigation measures are listed, and they may be adapted to the characteristics of the area of operation (e.g. the ground risk may be mitigated by flying over a river). When the UAS operator intends to conduct the same operation in another Member State, a copy of the authorisation issued by the competent authority of the Member State of registration needs to be sent to the NAA of the Member State of the UAS operations. A number of elements of the mitigation measures may remain valid, such as the way the operator is organised, the competences of the pilot, or the characteristics of the UAS, for example. Other elements instead need to be adapted to the geography of the area of operation (e.g. the operations cannot be conducted mostly over the river, or it is necessary to identify a flight path meeting the equivalent conditions in terms of the ground risk, the local airspace, terrain and climate). On these points and also on the airspace, terrain and climate, the UAS operators are expected to review and possibly update the mitigation means, but only in relation to those elements. The competent authority of the Member State of operation is not expected to review the full risk assessment, but to limit its activity to checking and providing the UAS operator and the competent authority of the Member State of registration with confirmation that the updated mitigation measures are satisfactory. Upon receipt of the confirmation, the UAS operator may start operating immediately, and the competent authority of registration will update the authorisation. The picture below illustrates an example of the case when an operation complying with one of the STSs listed in Appendix 1 to the UAS Regulation is conducted in a Member State other than the state of registration:

text: Annex II to ED Decision 2019/021/R

text: The UAS operator firstly submits the declaration to the competent authority of the Member State of registration, which, if the declaration complies with the UAS Regulation, issues a confirmation of receipt and completeness. The UAS operator will then provide the competent authority of the Member State of operations with a copy of the declaration and the confirmation of completeness received by the competent authority of the Member State of registration. There is no need for further verification.

text: Article 14

text: Registration of UAS operators and ‘certified’ UAS

text: NATIONAL CONTACT POINT FOR ACCESSING AND EXERCISING THE RIGHTS The competent authority should identify and publish the contact point for accessing and exercising the rights in accordance with

text: Regulation (EU) 2016/679

text: on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.

text: DISPLAY OF REGISTRATION INFORMATION (a) If the UAS operator owns the UAS, it should display on the UA the registration number received at the end of the registration process in a way that this information is readable at least when the UA is on the ground without the need for any devices other than eyeglasses or corrective lenses. (b) A QR code (quick response code) may be used. (c) If the size of the UA does not allow the mark to be displayed in a visible way on the fuselage, or the UA represents a real aircraft where affixing the marking on the UA would spoil the realism

text: Annex II to ED Decision 2019/021/R

text: of the representation, a marking inside the battery compartment is acceptable if the compartment is accessible. (d) If a UAS operator uses a UAS owned by a third party, the UAS operator that operates the UAS should: (1) register itself; (2) display its registration number on the UA; and (3) upload the registration number into the e-identification system, if the UA is equipped with one.

text: Article 16

text: UAS operations in the framework of model aircraft clubs and associations

text: GENERAL Unless differently provided by national regulation, a model aircraft club and association may obtain from the national competent authority an authorisation that is valid for all their members to operate UA according to conditions and limitations tailored for the club or association. The model aircraft club and association will submit to the competent authority the procedures that all members are required to follow. When the competent authority is satisfied with the procedures, organisational structure and management system of the model aircraft club and association, it may provide an authorisation that defines different limitations and conditions from those in the UAS Regulation. The authorisation will be limited to the operations conducted within the authorised club or association and within the territory of the Member State of the authorised competent authority. The authorisation cannot exempt members of the club or association from registering themselves according to Article 14 of the UAS Regulation; however, it may allow a model club or association to register their members on their behalf. The authorisation may also include operations by persons who temporarily join in with the activities of the club or association (e.g. for leisure during holidays or for a contest), as long as the procedures provided by the club or association define conditions acceptable to the competent authority.

text: Article 16

text: OPTIONS TO OPERATE A MODEL AIRCRAFT Model flyers have the following options to conduct their operations: (a) They may operate as members of a model club or association that has received from the competent authority an authorisation, as defined in Article 16 of the UAS Regulation. In this case, they should comply with the procedures of the model club or association in accordance with the authorisation. The authorisation should define all the deviations from the aforementioned Regulation granted to the model club or association’s members. Members must register themselves in accordance with Article 14 of the UAS Regulation, except when the model aircraft clubs and associations have obtained from the Member State the right to register their members in the registration system.

text: Annex II to ED Decision 2019/021/R

text: (b) In accordance with Article 15(2) of the UAS Regulation, Member States may define zones where UAS are exempted from certain technical requirements, and/or where the operational limitations are extended, including mass or height limitations. They may also define different height limitations for those zones. (c) The UAS may be operated in Subcategory A3, in which the following categories of UAS are allowed to fly according to the limitations and conditions defined in UAS.OPEN.040: (1) UAS with a class C0, C1, C2, C3, C4 CE mark; (2) UAS that meet the requirements defined in

text: Article 20

text: (b) of the UAS Regulation; and (3) privately built UAS with MTOMs of less than 25 kg.

text: ACTION IN CASES OF OPERATIONS/FLIGHTS THAT EXCEED THE CONDITIONS AND LIMITATIONS DEFINED IN THE OPERATIONAL AUTHORISATION When a model club or association is informed that a member has exceeded the conditions and limitations defined in the operational authorisation, appropriate measures will be taken, proportionate to the risk posed. Considering the level of risk, the model club or association decides whether the competent authority should be informed. In any case, occurrences that cause an injury to persons or where the safety of other aircraft was compromised, as defined in

text: Article 125 of Regulation (EU) 2018/1139

text: , must be reported by the model club or association to the competent authority.

text: Article 17

text: Designation of the competent authority

text: GENERAL Member States may also designate an entity as a competent authority only for specific tasks. It should be highlighted that in such a case, this entity must comply with

text: Article 62(3) of Regulation (EU) 2018/1139

text: and is the one that will be audited by EASA under

text: Article 85

text: (monitoring of Member State) of the same Regulation.

text: Article 18

text: (a) Tasks of the competent authority

text: ENFORCEMENT Member States are responsible for enforcing the UAS Regulation, and it is their decision to nominate the competent authority. In making this decision, Member States should consider that most of the UAS operations will occur in areas far from aerodromes, and therefore, the selected competent

text: Annex II to ED Decision 2019/021/R

text: authority should employ personnel able to verify that the UAS operations conducted in such areas are safe. In addition, the issues that are likely to occur more often will be related to noise, privacy and security. Taking all this into account, law enforcement authorities may be well-placed to fulfil that role. Law enforcement authorities may take different forms, depending on the Member State’s national legal framework.

text: Article 18

text: (e) Tasks of the competent authority

text: DOCUMENTS, RECORDS AND REPORTS TO BE KEPT (a) The competent authority should keep at least the following documentation: (1) operational authorisations, in accordance with Article 12(2) of the UAS Regulation: (i) the initial application for an authorisation as defined in UAS.SPEC.030(3) of Part-B and the associated documents; (ii) the application(s) for updated operational authorisations; (iii) the final version of the risk assessment performed by the UAS operator, and the supporting material; (iv) the UAS operator’s statement confirming that the intended UAS operation complies with any applicable European Union and national rules relating to it, in particular with regard to privacy, data protection, liability, insurance, security and environmental protection, in accordance with

text: Article 12(2)

text: (c) of the UAS Regulation; (v) the procedures to ensure that all operations comply with

text: Regulation (EU) 2016/679

text: on the protection of natural persons with regard to the processing of personal data and on the free movement of such data; (vi) confirmation by the competent authority of the Member State of operation that the updated mitigation measures are satisfactory for the operation at the intended location in accordance with Article 13(2) of the UAS Regulation; (vii) when applicable, a procedure for coordination with the relevant service provider for the airspace if the entire operation, or part of it, is to be conducted in controlled airspace; and (viii) up-to-date operational authorisation(s) with a table outlining successive changes; (2) declarations in accordance with Article 12(5) of the UAS Regulation: (i) up-to-date declarations with a table outlining successive changes; (ii) up-to-date confirmations of receipt and completeness, provided in accordance with

text: Article 12(5)

text: (b) of the UAS Regulation, with a table outlining successive changes; (3) remote pilots’ competency: (i) proof of competency for remote pilots that have passed the online theoretical knowledge examination in accordance with UAS.SPEC.020(4)(b) of Part-B;

text: Annex II to ED Decision 2019/021/R

text: (ii) certificates of remote pilot competency for remote pilots that have passed the examination in accordance with UAS.SPEC.030(2)(c) of Part-B, with the declaration of completion of the practical self-training provided by the remote pilot; and (iii) proof of competency or other certificates for remote pilots, as required by the STSs as defined in Appendix 1 to the UAS Regulation or the operational authorisations; (4) Light UAS Operator Certificates: (i) initial applications in accordance with UAS.LUC.010(2) of Part-C and associated documents; (ii) applications for amendments to an existing LUC, and the associated documents; and (iii) up-to-date terms of approval in accordance with UAS.LUC.050 of Part-C, with a table outlining the successive changes. (b) The records should be kept for at least for three years after their validity date expires.

text: Article 18

text: (h) Tasks of the competent authority

text: GUIDELINES FOR RISK-BASED OVERSIGHT (RBO) NOTE: The guidelines below are based on the document ‘Practices for risk-based oversight’, which may be found at the address below, and where further information may also be found: https://www.easa.europa.eu/document-library/general-publications/practices-risk-based-oversight That document: — highlights the relationship between RBO and the (safety) management system, the management of change, the overall performance of the organisation and the oversight cycle; — describes the interconnection, availability and exchange of data, which will significantly change the relationship between the authority and their regulated entities, as well as their ongoing management of safety; — does not constitute regulatory material nor means of compliance nor guidance material. It reflects the RBO state of play to date, in an effort to gain a common understanding and to look ahead; and — can be used as guidelines for competent authorities who have to implement RBO.

text: (a) General Definitions: (1) Oversight: the function by means of which a competent authority ensures that the applicable requirements are met by regulated entities. (2) Risk profile: the element of risks that are inherent to the nature and operations of the regulated entity, this includes the: — specific nature of the organisation; — complexity of its activities; and

text: Annex II to ED Decision 2019/021/R

text: — risks stemming from the activities carried out. (3) Safety performance: the demonstration of how effectively a regulated entity can mitigate its risks, substantiated through the proven ability to: — comply with the applicable requirements; — implement and maintain effective safety management; — identify and manage safety risks; and — achieve and maintain safe operations. The results of past certification or oversight also need to be taken into account. (4) RBO: a way of performing oversight, in which: — planning is driven by the combination of the risk profile and safety performance; and — execution focuses on the management of risk, besides ensuring compliance. (b) The RBO scheme is summed-up by the drawing below:

text: (1) the risk profile and oversight are described in paragraph 3 of the ‘Practices for risk-based oversight’; (2) the management of safety information and information sharing with other authorities are described in paragraph 4 of ‘Practices for risk-based oversight’; (3) the training and qualification of inspectors are described in paragraph 4.3 of ‘Practices for risk-based oversight’; (4) conducting risk-based audits is described in paragraph 5 of ‘Practices for risk-based oversight’.

text: Annex II to ED Decision 2019/021/R

text: Article 19

text: Safety information

text: EXCHANGE OF SAFETY INFORMATION Cooperation between competent authorities should be organised pursuant to

text: Article 61 of Regulation (EU) 2018/1139

text: . Cooperation between market surveillance authorities and the exchange of safety-related and non-compliance information should be organised pursuant to

text: Regulation (EC) No 765/2008

text: . Article 19 of the UAS Regulation is intended to help organise the information flow and cooperation between the competent authorities on the one hand, and between the market surveillance authorities on the other. Cooperation should be organised primarily at the Member State level. All the competent authorities concerned should make the best use of the information systems defined in

text: Articles 22

text: ‘Exchange of information — Community Rapid Information System’ and 23 ‘General information support system’ of

text: Regulation (EC) No 765/2008

text: , as well as of the occurrence-reporting system of

text: Regulation (EU) No 376/2014

text: OCCURRENCE REPORT According to

text: Regulation (EU) No 376/2014

text: , occurrences shall be reported when they refer to a condition which endangers, or which, if not corrected or addressed, would endanger an aircraft, its occupants, any other person, equipment or installation affecting aircraft operations. Obligations to report apply in accordance with

text: Regulation (EU) No 376/2014

text: , namely its

text: Article 3(2)

text: , which limits the reporting of events for operations with UA for which a certificate or declaration is not required, to occurrences and other safety-related information involving such UA if the event resulted in a fatal or serious injury to a person, or it involved aircraft other than UA.