Tuesday, July 31, 2012

The Seven Steps to a CE Mark: Step 5, Compile the Technical Documentation

In accordance with the Machinery Directive, technical documentation specifically comprises:

• An overall drawing of the machinery and drawings of the control circuits
• Full, detailed drawings (accompanied by any calculation notes, test results, etc.) required to check the conformity of the machinery with the essential health and safety requirements
• A list of the essential requirements of this directive, standards and other technical specifications used in the design of the machinery, a description of the protective measures implemented to eliminate hazards presented by the machinery (generally covered by the risk analysis)
• Technical reports or certificates; reports or test results showing conformity
• The machine’s operating instructions
• A general machine description
• Declaration of conformity or declaration of incorporation plus the assembly instructions
• Declarations of conformity for the machines or devices incorporated into the machinery

This documentation does not have to be permanently available in material form. However, it must be possible to assemble it and make it available within a period of time commensurate with its importance. It must be retained for at least ten years following the date of manufacture and be available to present to the relevant national authorities. In the case of series manufacture, that period shall start on the date that the last machine is produced.


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