The Technical File is the set of documentation which demonstrate the conformity of the machinery to the E.S.R. essential standard requirements.
This documents allows the market surveillance appointed authorities to easily checl the conformity of the machinery considered.
The obligation to compile a technical file applies to the manufacturer. If the machinery is imported from an extra EC country, areas in which the manufacturer has no obligation to draft the file, this obligation is passed on to the importer or agent.
The technical file must be compiled in one or more official Community languages and must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery.
DOCUMENTATION IN THE TECHNICAL FILE
As defined in annex VII of the machinery Directive2006/42/EC, the technical file comprises the following documentation:
- a general description of the machinery;
- the overall drawing of the machinery and drawings of the control circuits, aswell 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:
- a list of the essential health and safety requirements which apply to the machinery
- 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.
