The technical documentation must render the design, manufacture and operation of the product intelligible and enable an assessment to be made of its conformity with the requirements of the Directive.

The documentation shall include in so far as relevant for assessment:

• general description of the type,

• conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits etc.,

• descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,

• results of design calculations made and of examinations, etc.,

• test reports,

• the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.