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Regulation 12(2)(c) and 16(1)
1. The technical documentation shall comprise all relevant data and means used by the manufacturer to ensure that equipment complies with the applicable international standards. The documentation shall make it possible to understand the design, manufacture and operation of the product, and to assess compliance with the applicable international standards.
2. The technical documentation shall, so far as relevant to the particular assessment, include:
(1) a general description of the specimen;
(2) conceptual design, build standard and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
(3) descriptions and explanations necessary for the understanding of the drawings and schemes referred to in (2) above, including any necessary descriptions and explanations of the equipment;
(4) the results of design calculations made, impartial examinations carried out, etc.;
(5) impartial test reports;
(6) manuals for installation, use and maintenance.
3. Where appropriate, the design documentation shall contain the following:
(1) attestations relating to other items of equipment incorporated into the specimen;
(2) attestations and certificates relating to the methods of manufacture or inspection or monitoring of the specimen;
(3) any other document that makes it possible for the notified body to better perform its assessment.
4. A specimen may cover several versions of the equipment provided that the differences between the versions do not affect the level of safety or the other applicable international standards.
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