What is a Technical Construction File?
Annex 7 of Machinery Directive 2006/42/EC, details the requirements of a Technical File. It states that the Technical File "must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment."
The Technical File should contain the following information:
(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:
- 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;
(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.
For partly completed machinery, the Technical File should contain the following information:
(a) a construction file including:
- the overall drawing of the partly completed machinery and drawings of the control circuits,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,
- the risk assessment documentation showing the procedure followed, including:
- a list of the essential health and safety requirements applied and fulfilled,
- the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,
- 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 assembly instructions for the partly completed machinery;
(b) for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.
In both instances, 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.
Laidler Services
Laidler Associates can assist companies with the production of their technical Files, and for companies based outside of the European Union, they can act as the person authorised to hold the technical file within the European Union.
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