Assembly instructions

Special technical documents for incomplete machines

Establishment of the specific technical documents: on the basis of these documents, it must be possible to identify the requirements of this directive that apply and to check compliance with them. They must cover the design, construction, and operation of the incomplete machine to the extent necessary for assessing conformity with the essential health and safety requirements applied.

The documents must be drawn up in one or more community languages.

They include:

1. a) a technical documentation containing the following information or documents:

• a general arrangement drawing of the incomplete machine and the circuit diagrams of the control circuits,
• full detailed drawings, including, where appropriate, calculations, test results, certificates, etc., required to check the conformity of the incomplete machine with the essential health and safety requirements applied
• the risk assessment documents indicating which procedure has been followed; this includes:
  
  
  
  • a list of the essential health and safety requirements which have been applied and are being complied with,
  • a description of the protective measures taken to eliminate identified hazards or to reduce risks and, where appropriate, an indication of the residual risks
  • the standards and other technical specifications applied, indicating the essential health and safety requirements covered by these standards,
  • any technical report giving the results of the tests carried out by the manufacturer themselves or by a body chosen by the manufacturer or their authorized representative
  • a copy of the assembly instructions for the incomplete machine;

1. b) in the case of series manufacture, a statement of the internal measures taken to ensure that all incomplete machines are in conformity with the essential health and safety requirements.

The manufacturer must carry out the necessary inspections and tests on the components, accessories or incomplete machine to check that the incomplete machine can be assembled and used safely by virtue of its design or construction. The relevant reports and results shall be included in the technical file.

The special technical file must be kept at the disposal of the competent authorities of the Member States for at least 10 years from the date of manufacture of the incomplete machine or, in the case of series production, from the date of completion of the last unit, and must be made available to the competent authorities of the Member States on request. It does not necessarily have to be located in community territory, nor does it have to be permanently available in physical form. However, the person designated in the declaration of installation must be able to compile the documentation and submit it to the competent authority.

Failure to submit the special technical file to the competent national authorities on reasoned request may constitute sufficient grounds for doubting the conformity of the incomplete machine with the applied and certified essential health and safety requirements.