Principles, Standards and Implementation

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Regulations

Technical File

The manufacturer or his authorized representative must prepare a Technical File to provide evidence of conformity with the EHSRs. This file should include all relevant information such as test results, drawings, specifications, etc.

It is not essential that all the information is permanently available as hard copy but it must be possible to make the entire Technical File available for inspection on request from a competent authority (a body appointed by an EU country to monitor the conformity of machinery).

At the minimum, the following documentation must be included in a Technical File:

Figure 3: Document Assessment Results

1.	Overall drawings of the equipment including control circuit drawings.
2.	Detailed drawings, calculation notes, test results, etc. required for checking the conformity of the machinery with the EHSRs.
3.	Risk assessment documentation, including a list of the essential health and safety requirements which apply to the machinery and a description of the protective measures implemented.
4.	A list of the standards and other technical specifications used, indicating the essential health and safety requirements covered.
5.	A description of methods adopted to eliminate hazards presented by the machinery.
6.	If relevant, any technical reports or certificates obtained from a test facility or other body.
7.	If conformity is declared with a Harmonized European Standard, any technical report giving test results for it.
8.	A copy of the instructions for the machinery.
9.	Where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery.
10.	Where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery.
11.	A copy of the EC declaration of conformity.

For series manufacture, details of internal measures (quality systems, for example) to ensure all machinery produced remains in conformity:

• The manufacturer must carry out necessary research or tests on components, fittings or the completed machinery to determine whether by its design and construction it is capable of being erected and put into service safely.
  
• The technical file need not exist as a permanent single file, but it must be possible to assemble it to make it available in a reasonable time. It must be available for ten years following production of the last unit.
  

The technical file does not need to include detailed plans or any other specific information regarding sub-assemblies used for the manufacture of the machinery, unless they are essential to verify conformity with the EHSRs.