A4.2 Technical file
The technical file must demonstrate that the equipment complies with the requirements of the relevant directive(s). It must cover the design, manufacture and operation of the equipment to the extent necessary for assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions apply and are described in the relevant directive(s).
The technical file shall comprise a construction file including:
- A general description of the equipment;
- The overall drawing of the equipment and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the equipment;
- Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment;
- Full detailed drawings, accompanied by any calculation notes, test results, certificates, etc, required to check the conformity of the equipment with the essential health and safety requirements.
- The documentation on risk assessment demonstrating the procedure followed.
This documentation shall include:
- A list of the essential health and safety requirements which apply to the equipment;
- The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the equipment;
- The standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards;
- Any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative;
- A copy of the instructions for the equipment;
- Where appropriate, the declaration of incorporation for included partly completed equipment and the relevant assembly instructions for such equipment;
- Where appropriate, copies of the EC declaration of conformity of equipment or other products incorporated into the equipment;
- Where appropriate, for pressure systems, documentation relating to compliance with the materials specifications by using materials which comply with harmonised standards, by using materials covered by a European approval of pressure equipment materials or by a particular material appraisal;
- A copy of the EC declaration of conformity;
- Results of design calculations made, examinations carried out, etc;
- Test reports.
For series manufacture, the internal measures that will be implemented to ensure that the equipment remains in conformity with the provisions of the relevant directive(s).
The manufacturer must carry out necessary research and tests on components, fittings or the completed equipment to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
The technical file must be made available to the competent authorities of the member states for at least 10 years following the date of manufacture of the equipment or, in the case of series manufacture, of the last unit produced. The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the equipment, unless knowledge of them is essential for verification of conformity with the essential health and safety requirements.