Paragraph 2 Technical documentationF1

make it possible to assess the product's conformity with the essential requirements that apply to it;

include an adequate analysis and assessment of any risks;

specify the essential requirements that apply to the product; and

cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

a general description of the product;

conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

results of design calculations made and examinations carried out;

test reports.