Regulation (EU) No 748/2012
This Subpart establishes the procedure for issuing ETSO authorisations and the rules governing the rights and obligations of applicants for, or holders of, such authorisations.
Regulation (EU) No 748/2012
Any natural or legal person that produces or is preparing to produce an ETSO article, and that has demonstrated, or is in the process of demonstrating, its capability under point 21.A.602B shall be eligible as an applicant for an ETSO authorisation.
21.A.602B Demonstration of capability
Regulation (EU) No 748/2012
Any applicant for an ETSO authorisation shall demonstrate its capability as follows:
(a) for production, by holding a production organisation approval, issued in accordance with Subpart G, or through compliance with Subpart F procedures; and
(b) for design:
1. for an Auxiliary Power Unit, by holding a design organisation approval, issued by the Agency in accordance with Subpart J;
2. for all other articles, by using procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Annex I (Part 21).
AMC 21.A.602B(b)(2) Procedures for ETSO authorisations
ED Decision 2012/020/R
1. Scope
1.1 A manual of procedures must set out specific design practices, resources and sequence of activities relevant for the specific projects, taking account of Part 21 requirements.
1.2 These procedures must be concise and limited to the information needed for quality and proper control of activities by the applicant/holder, and by the Agency.
2. Management of the ETSO authorisation process
A procedure explaining how the application to the Agency and certification process to obtain an ETSOA will be made, must be established.
3. Management of design changes
3.1 A procedure taking into account 21.A.611, must be established for the classification and approval of design changes on articles under ETSO authorisation
3.2 Procedure for the classification and approval of repairs and unintentional deviations from the approved design data occurring in production (concessions or non-conformance's) must be established.
4. Obligations addressed in 21.A.609
The applicant should establish the necessary procedures to show to the Agency how it will fulfil the obligations under 21.A.609.
For issue of information and instructions, a procedure following the principles of AMC 21.A.14(b), paragraph 4 must be established.
5. Control of design sub-contractors
The applicant must establish the necessary procedures to show to the Agency how it will control design sub-contractors.
Regulation (EU) No 748/2012
(a) An application for an ETSO authorisation shall be made in a form and manner established by the Agency and shall include an outline of the information required by point 21.A.605.
(b) When a series of minor changes in accordance with point 21.A.611 is anticipated, the applicant shall set forth in its application the basic model number of the article and the associated part numbers with open brackets after it to denote that suffix change letters or numbers (or combinations of them) will be added from time to time.
21.A.604 ETSO authorisation for an auxiliary power unit (APU)
Regulation (EU) 2022/201
With regard to an ETSO authorisation for an APU:
(a) by way of derogation from points 21.A.9, 21.A.603, 21.A.610 and 21.A.621, the following points shall apply: points 21.A.15, 21.A.20, 21.A.21, 21.A.31, 21.A.33, 21.A.44, 21.A.47, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of the type-certificate;
(b) by way of derogation from point 21.A.611, the requirements of Subpart D shall apply to the approval of design changes by the APU ETSO authorisation holder and design changes from other applicants classified as a minor change, and the requirements of Subpart E shall apply to the approval of design changes by other applicants classified as a major change. Where the requirements of Subpart E apply, a separate ETSO authorisation shall be issued instead of a supplemental type certificate; and
(c) the requirements of Subpart M shall apply to the approval of repair designs.
Regulation (EU) 2019/897
(a) The applicant shall submit to the Agency the following documents:
1. a certification programme for the ETSO authorisation, setting out the means to demonstrate compliance with point 21.A.606(b);
2. a statement of compliance certifying that the applicant has met the requirements of this Subpart;
3. a declaration of design and performance (DDP), stating that the applicant has demonstrated that the article complies with the applicable ETSO in accordance with the certification programme;
4. a copy of the technical data required in the applicable ETSO;
5. the exposition, or a reference to the exposition, referred to in point 21.A.143 for the purpose of obtaining an appropriate production organisation approval under Subpart G or the manual, or a reference to the manual, referred to in point 21.A.125A(b) for the purpose of manufacturing under Subpart F without production organisation approval;
6. for an APU, the handbook, or a reference to the handbook, referred to in point 21.A.243 for the purpose of obtaining an appropriate design organisation approval under Subpart J;
7. for all other articles, the procedures, or a reference to the procedures, referred to in point 21.A.602B(b)(2);
(b) The applicant shall report to the Agency any difficulty or event encountered during the approval process that may significantly impact the ETSO authorisation.
AMC 21.A.605(a)(1) Certification programme
ED Decision 2019/018/R
(a) For the purpose of the compliance demonstration in accordance with point 21.A.606(b), the applicant should:
(1) establish a certification programme;
(2) submit the certification programme to EASA; and
(3) keep the certification programme updated during the authorisation process.
(b) The certification programme should contain the following information:
(1) a detailed description of the relevant European technical standard order (ETSO) article, including all of its configurations to be certified, and the identification of ETSO and non-ETSO functions, if any;
(2) the applicable CS-ETSO, in case of different minimum performance standard (MPS) available, the selected MPS, the other requirements and any optional aspects (applicable standards, applicable requirements, choice of classes (if applicable)) as well as the expected deviations;
(3) the operating characteristics and the expected limitations;
(4) the intended use of the article and the kind of operations for which the approval is requested;
(5) the proposed means of compliance, including the list of documents and deliverables for EASA;
(6) an overview of the safety assessment for the functions supported by the article, including the main failure conditions, their classification, the associated assumptions, and architectural features supporting the safety aspects;
(7) the way in which the applicant will record the justifications of compliance; and
(8) a project schedule, including major milestones.
GM 21.A.605(b) Reporting from the compliance demonstration process and updates to the certification programme
ED Decision 2019/018/R
The applicant should report to EASA any unexpected difficulty or event encountered during the compliance demonstration which invalidates or appreciably affects the assumptions previously made, e.g.:
— an increase in the severity of the consequences of a certain condition (e.g. a failure mode) of the article;
— one or more significantly reduced margins on the ‘pass–fail’ criteria of the compliance demonstration;
— an unusual interpretation of the results of the compliance demonstration;
— a deviation from the agreed means as defined in the certification programme;
— a change to the conditions set out in the AMC No 2 to 21.B.100(b); and
— any potential deviations discovered by the applicant.
The applicant should also evaluate whether the unexpected difficulty or event encountered will impact on the certification programme and, if necessary, they should amend the certification programme as per point 21.A.603.
21.A.606 Requirements for the issuance of an ETSO authorisation
Regulation (EU) 2019/897
In order to be issued an ETSO authorisation, the applicant shall:
(a) demonstrate its capability in accordance with point 21.A.602B;
(b) demonstrate that the article complies with the technical conditions of the applicable ETSO or with deviations therefrom approved in accordance with point 21.A.610, if any;
(c) comply with the requirements of this Subpart; and
(d) declare that no feature or characteristic has been identified that may make the article unsafe for the uses for which certification is requested.
ED Decision 2019/018/R
The related declaration should confirm that compliance with the applicable ETSO is successfully demonstrated and that all the assumptions, constraints, deviations, limitations, and open problem reports that are relevant for the approval of the installation are defined for both the ETSO and the non-ETSO functions.
Additionally, the applicant should demonstrate and declare that the non-ETSO functions do not interfere with the ETSO functions.
21.A.607 ETSO authorisation privileges
Regulation (EU) No 748/2012
The holder of an ETSO authorisation is entitled to produce and to mark the article with the appropriate ETSO marking.
21.A.608 Declaration of Design and Performance (DDP)
Regulation (EU) No 748/2012
(a) The DDP shall contain at least the following information:
1. information corresponding to point 21.A.31(a) and (b), identifying the article and its design and testing standard;
2. the rated performance of the article, where appropriate, either directly or by reference to other supplementary documents;
3. a statement of compliance certifying that the article has met the appropriate ETSO;
4. reference to relevant test reports;
5. reference to the appropriate Maintenance, Overhaul and Repair Manuals;
6. the levels of compliance, where various levels of compliance are allowed by the ETSO;
7. list of deviations accepted in accordance with point 21.A.610.
(b) The DDP shall be endorsed with the date and signature of the holder of the ETSO authorisation, or its authorised representative.
AMC 21.A.608 Declaration of Design and Performance
ED Decision 2012/020/R
STANDARD FORM
DDP No. ………………………………………………………………
ISSUE No. ……………………………………………………….
1. Name and address of manufacturer.
2. Description and identification of article including:
Type No
Modification Standard
Master drawing record
Weight and overall dimensions
3. Specification reference, i.e., ETSO No. and Manufacturer’s design specification.
4. The rated performance of the article directly or by reference to other documents.
5. Particulars of approvals held for the equipment.
6. Reference to qualification test report.
7. Service and Instruction Manual reference number.
8. Statement of compliance with the appropriate ETSO and any deviations therefrom.
9. A statement of the level of compliance with the ETSO in respect of the ability of the article to withstand various ambient conditions or to exhibit various properties.
The following are examples of information to be given under this heading depending on the nature of the article and the specifications of the ETSO.
(a) Environmental Qualification
i. Temperature and Altitude
ii. Temperature Variation
iii. Humidity
iv. Operational Shocks and Crash Safety
v. Vibration
vi. Explosion Proofness
vii. Waterproofness
viii. Fluids Susceptibility
ix. Sand and Dust
x. Fungus Resistance
xi. Salt Spray
xii. Magnetic Effect
xiii. Power Input
xiv. Voltage Spike
xv. Audio Frequency Conducted Susceptibility - Power Inputs
xvi. Induced Signal Susceptibility
xvii. Radio Frequency Susceptibility (Radiated and Conducted)
xviii. Emission of Radio Frequency Energy
xix. Lightning Induced Transient Susceptibility
xx. Lightning Direct Effects
xxi. Icing
xxii. Electrostatic Discharge
xxiii. Fire, Flammability
(Note: The manufacturer should list environmental categories for each of the sections of the issue of EUROCAE ED-14/RTCA DO-160 that was used to qualify the article.)
(b) For radio transmitters the transmitting frequency band, maximum transmitting power, and emission designator.
(c) Working and ultimate pressure or loads.
(d) Time rating (e.g., continuous, intermittent) or duty cycle.
(e) Limits of accuracy of measuring instruments.
(f) Any other known limitations which may limit the application in the aircraft e.g., restrictions in mounting attitude.
10. A statement of the software level(s) used or ‘None’ if not applicable.
(Note: Software levels (software development assurance levels (DAL)) are those defined in the industry document referred in the latest edition of AMC 20-115)
11. A statement of design assurance level for complex hardware or a statement indicating whether complex hardware is embedded or not in the product.
(Note: Complex hardware design assurance levels are those defined in the applicable issue of EUROCAE ED–80/RTCA DO-254.)
12. The declaration in this document is made under the authority of
…………………………………………………………………………………………..(name of manufacturer)
(Manufacturer’s name) cannot accept responsibility for equipment used outside the limiting conditions stated above without their agreement.
Date: ………….Signed………………………………………….....(Manufacturer’s authorised representative)
21.A.609 Obligations of holders of ETSO authorisations
Regulation (EU) 2022/201
The holder of an ETSO authorisation under this Subpart shall:
(a) manufacture each article in accordance with Subpart G or Subpart F that ensures that each completed article conforms to its design data and is safe for installation;
(b) prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, an updated set of complete technical data and records in accordance with point 21.A.5;
(c) prepare, maintain and update master copies of all manuals required by the applicable airworthiness specifications for the article;
(d) make available to users of the article and to the Agency on request those maintenance, overhaul and repair manuals necessary for the usage and maintenance of the article, and changes to those manuals;
(e) mark each article in accordance with point 21.A.807;
(f) comply with points 21.A.3A, 21.A.3B, 21.A.4 and 21.A.9;
(g) continue to meet the qualification requirements of point 21.A.602B.
AMC1 21.A.609(c) and (d) Obligations of holders of ETSO authorisations
ED Decision 2021/007/R
In CS-ETSO, there is no specification related to ICA, neither in Subpart A, nor in each specific ETSO.
Although an ETSO article itself typically does not require ICA, the applicable airworthiness standards may require the design approval holder (DAH) or the design approval applicant (DAA) who install an ETSO article into their product to develop ICA that describe an ETSO article’s installation requirements, within the context of the product, to the extent necessary to ensure the product’s continued airworthiness.
In addition, if the DAH or the DAA who install an ETSO article into their product explicitly uses ETSO provisions to demonstrate compliance with an installation requirement, they should review all the maintenance and inspection instructions for the particular ETSO article when defining the ICA of the product.
It may be necessary for the DAH or the DAA to incorporate these instructions into the ICA of the product to ensure that the ETSO article continues to satisfy the terms of its ETSO authorisation after installation.
Any DAH or DAA who wishes to install an ETSO article should comply with point 21.A.303.
For this, the applicant for an ETSO authorisation may provide by the time of the application and before the authorisation is issued (in accordance with point 21.A.605) the following:
— instructions that cover periodic maintenance, calibration, and repair for the continued airworthiness of the article, including specific guidance on the limits of wear and damage that would warrant replacement;
— the recommended inspection intervals, which may be affected by storage and operating conditions (i.e. temperature, humidity, etc.).
21.A.610 Approval for deviation
Regulation (EU) No 748/2012
(a) Each manufacturer who requests approval to deviate from any performance standard of an ETSO shall demonstrate that the standards from which a deviation is requested are compensated for by factors or design features providing an equivalent level of safety.
(b) The request for approval to deviate, together with all pertinent data, shall be submitted to the Agency.
Regulation (EU) No 748/2012
(a) The holder of the ETSO authorisation may make minor design changes (any change other than a major change) without further authorisation by the Agency. In this case, the changed article keeps the original model number (part number changes or amendments shall be used to identify minor changes) and the holder shall forward to the Agency any revised data that are necessary for compliance with point 21.A.603(b).
(b) Any design change by the holder of the ETSO authorisation that is extensive enough to require a substantially complete investigation to determine compliance with an ETSO is a major change. Before making such a change, the holder shall assign a new type or model designation to the article and apply for a new authorisation under point 21.A.603.
(c) No design change by any natural or legal person other than the holder of the ETSO authorisation who submitted the statement of compliance for the article is eligible for approval under this Subpart O unless the person seeking the approval applies under point 21.A.603 for a separate ETSO authorisation.
ED Decision 2012/020/R
A change to an ETSO article can either be seen:
— under this 21.A.611 in the context of an ETSO authorisation, i.e., when an article as such is specifically approved under Subpart O, with dedicated rules that give specific rights and obligations to the designer of the article, irrespective of any product type design or change to the type design. For a change to such an article, irrespective of installation on any aircraft, Subpart O, and this 21.A.611 in particular, should be followed; or
— when an airline or a maintenance organisation is designing a change (based on data not published in the TC holder or Original Equipment Manufacturer documentation) on an article installed on an aircraft, such a change can be considered as a change to the product in which the article is installed, not to the article taken in isolation. Therefore Subpart D can be used for the approval of this change that will be identified as ‘change to product x affecting article y’, but not ‘change to article y’.
21.A.619 Duration and continued validity
Regulation (EU) 2022/201
(a) An ETSO authorisation shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:
1. the conditions set when the ETSO authorisation was granted continue to be observed by the applicant;
2. the obligations specified in point 21.A.609 continue to be discharged by the ETSO authorisation holder;
3. the holder of the ETSO authorisation or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;
4. it has been proved that the ETSO article does not give rise to unacceptable hazards in service;
5. the ETSO authorisation has not been revoked by the Agency under point 21.B.65, or surrendered by its holder.
(b) Upon surrender or revocation, the ETSO authorisation shall be returned to the Agency.