Sch 3A Pt 6 para 2 Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements: (a) a general description of the product, (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, (d) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied, (e) results of design calculations made, examinations carried out, etc., and (f) test reports.