Source: https://www.easa.europa.eu/node/19008
Timestamp: 2018-07-21 07:51:28
Document Index: 793371747

Matched Legal Cases: ['art-21', 'art 21', 'art 21', 'art 21', 'art 21', 'art-21', 'art 21', 'art 145', 'art 21', 'art 145']

Initial Airworthiness | EASA
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First of all it should be clear that the definition of "parts and appliances" (Refer to article 3 of the Basic Regulation) includes software. This is software that is installed in an aircraft and used in operating or controlling that aircraft. The rest of this response only refers to this type of software.
Marking of this Field Loadable Software must be in accordance with Subpart Q of Part-21. For practical reasons the marking could be on the software "container" (e.g. the CD carrying the software).
The term "critical part" or "critical component" is used in various EASA requirements, certification specifications and also in the EU-US bilateral, however it is not always defined.
A general definition does not exist. There are currently basically three different definitions:
CS 27-29-VLR.602(a): A critical part is a part, the failure of which could have a catastrophic effect upon the rotorcraft, and for which critical characteristics have been identified which must be controlled to ensure the required level of integrity.
for engines, propellers and APUs:
CS-E.510(c) It is recognised that the probability of Primary Failures of certain single elements cannot be sensibly estimated in numerical terms. If the Failure of such elements is likely to result in Hazardous Engine Effects, reliance must be placed on meeting the prescribed integrity specifications of CS-E 515 (Engine critical parts) in order to support the objective of an Extremely Remote probability of Failure.
(similar for CS-P.150(c) and CS-P.160 and also for CS-APU.210(c) and CS-APU.150)
in the EU-US bilateral:
A "Critical component" means a part identified as critical by the design approval holder during the product type validation process, or otherwise by the exporting authority. Typically, such components include parts for which a replacement time, inspection interval, or related procedure is specified in the Airworthiness Limitations section or certification maintenance requirements of the manufacturer's maintenance manual or Instructions for Continued Airworthiness.
Each of the above definitions should be used only within their own context and for their own purpose i.e. the definition of the bilateral is only relevant for the automatic acceptance of PMA parts and repair design from the US. Where the term "critical part" is not defined the dictionary meaning of "critical" should be used i.e. crucial, decisive, important, etc.
For the application of Part 21A.805 critical parts are those identified as such by the design approval holder, which for rotorcraft, engines, propellers and APUs as a minimum should be those using the definitions of the relevant CS.
Article 6 of the Basic Regulation transposes into Community law the International standards of the International Civil Aviation Organisation (ICAO) related to the environmental certification of aeronautical products. The Agency is involved, together with the Commission, in the further development of such standards to ensure that they do take into account Community objectives in this field. Another important task of the Agency is to verify that the design of products comply with environmental requirements. The Agency shall therefore establish and notify the appropriate environmental requirements for each product for which environmental certification is required and issue the appropriate environmental certificates.
Such powers are established by articles 20(d) and (h) respectively of the Basic Regulation and further detailed in Part 21.A.18 "Designation of applicable environmental protection requirements and certification specifications" of Commission Regulation (EC) No 1702/2003.
Can manufacturers of raw materials obtain a Production Organisation Approval (POA) under Part 21 Subpart G? (19/11/2004)
The Agency has concluded after a thorough review that the current Basic Regulation and Part 21 do not provide for the approval of manufacturers of raw materials. Only organisations responsible for the manufacturing and subsequent release of a 'product' and 'parts and appliances' as defined in the Basic Regulation Article 3 (c) and (d) are required to hold a POA and are therefore eligible to apply for such an approval. ED Decision 2007/012/R introduced an amendment to AMC/GM to Part-21 bringing all AMC and GM to Part 21 back into line with the EC Regulations regarding this issue and thus removing any ambiguity.
Should parts fabricated under a maintenance approval (Part 145) be marked with an EPA (European Part Approval) marking in accordance with Part 21A.804(a)(3)?
A Part 145 approved organisation can only fabricate parts for its own use in accordance with approved design data (145.A.42(c)). If that data comes from the Type Certificate holder; 21A.804(a)(3) would not be applicable and those parts will not need EPA marking. If the data comes from a Supplemental Type Certificate holder, minor change approval holder or repair approval holder, the parts will have to be marked as prescribed in the applicable data which should include an EPA marking since 28/3/2004.
EASA STC’s being presented for approval when the pre-mod configuration is not EASA approved. What are EASA changes embedded in Non-EASA approved design?
21.A.101 and 21.A.103 require that the changed product meets the applicable certification basis. Therefore the change for which EASA has received an application needs to be demonstrated compliant to the EASA certification basis on product level. It is not sufficient to demonstrate compliance on change level only.
The change, applied for EASA approval, must include all affected parts of the non-approved change that builds the interface to the EASA approved product and all affected compliance demonstration (influences on the product and the non-approved interface change).
A limitation is likely to be necessary that the STC cannot be installed on an EASA registered product as long as the interface change is not yet EASA approved.