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13.—(1) In the case of relevant machinery which is not Schedule 4 machinery the responsible person must draw up a technical file which comprises—
(a)an overall drawing of the machinery together with drawings of the control circuits;
(b)full detailed drawings, accompanied by any calculation notes, test results and such other data as may be required to check the conformity of the machinery with the essential health and safety requirements;
(c)a list of:
(i)the essential health and safety requirements;
(ii)transposed harmonised standards;
(iii)standards; and
(iv)other technical specifications,
which were used when the machinery was designed;
(d)a description of methods adopted to eliminate hazards presented by the machinery;
(e)if he so desires, any technical report or certificate obtained from a competent body or laboratory(1);
(f)if he declares conformity with a transposed harmonised standard which provides therefor, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory; and
(g)a copy of the instructions for the machinery drawn up in accordance with paragraph 1.7.4 of Schedule 3 hereto.
(2) For series manufacture, the responsible person must also have available documentation in respect of the internal measures that will be implemented to ensure that all the items of machinery so produced are in conformity with the provisions of the Machinery Directive.
(3) Where the file referred to in paragraph (1) above is drawn up in the United Kingdom it shall be in English always provided that the instructions for the machinery referred to in sub-paragraph (g) thereof shall be in such languages as are specified in paragraph 1.7.4(b) of Schedule 3 hereto.
A body or laboratory meeting the assessment criteria laid down in the relevant harmonised standards is presumed to be competent for the purposes of this regulation.
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