Machinery Directive 2006/42/EC
Technical File Contents
The Contents of a Technical File are detailed in ANNEX VII of the Machinery Directive 2006/42/EC;
The technical file shall comprise the following (This is for a completed machine):
(a) a construction file including:
- a general description of the machinery,
- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,
- the documentation on risk assessment demonstrating the procedure followed, including: (i) a list of the essential health and safety requirements which apply to the machinery, (ii) 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 machinery,
- 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 machinery,
- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
- where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,
- a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.
The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery 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.