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The documentation referred to in Article 8(1) must comprise all relevant data on the means used by the manufacturer to ensure that PPE complies with the basic requirements relating to it.
In the case of PPE models referred to in Article 8(2), the documentation must comprise in particular:
1. the manufacturer’s technical file consisting of:
(a)overall and detailed plans of the PPE accompanied, where appropriate, by calculation notes and the results of prototype tests in so far as necessary for the verification of compliance with the basic requirements;
(b)an exhaustive list of the basic safety requirements and of the harmonised standards or other technical specifications referred to in Articles 3 and 5, taken into account in the design of the model;
2. a description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production PPE with the harmonised standards or other technical specifications and to maintain quality level;
3. a copy of the information notice referred to in Annex II, 1.4.
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