附属書IV 技術文書

The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the machinery or related product with the applicable essential health and safety requirements set out in Annex III.

The technical documentation shall include at least the following elements:

(a)a complete description of the machinery or related product and of its intended use;

(b)the documentation on risk assessment demonstrating the procedure carried out, including:

(i)a list of the essential health and safety requirements that are applicable to the machinery or related product;

(ii)the description of the protective measures implemented to meet each applicable essential health and safety requirement and, when appropriate, the indication of the residual risks associated with the machinery or related product;

(c)design and manufacturing drawings and schemes of the machinery or related product and of its components, sub-assemblies and circuits;

(d)the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (c) and of the operation of the machinery or related product;

(e)the references of the harmonised standards referred to in Article 20(1) or common specifications adopted by the Commission in accordance with Article 20(3) that have been applied for the design and manufacture of the machinery or related product. In the event of partial application of harmonised standards or common specifications, the documentation shall specify the parts, which have been applied;

(f)where harmonised standards or common specifications have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to meet each applicable essential health and safety requirement;

(g)reports and/or results of the design calculations, tests, inspections and examinations carried out to verify the conformity of the machinery or related product with the applicable essential health and safety requirements;

(h)a description of the means used by the manufacturer during the production of the machinery or related product to ensure the conformity of the machinery or related product produced with the design specifications;

(i)a copy of the instructions for use and the information set out in section 1.7.4 of Annex III;

(j)where appropriate, the EU declaration of incorporation for partly completed machinery set out in Annex V, Part B, and the assembly instructions set out in Annex XI;

(k)where appropriate, copies of the EU declarations of conformity of machinery or related products as well as any product covered by other Union harmonisation legislation incorporated into the machinery or related product;

(l)for machinery or related products produced in series, the internal measures that will be implemented to ensure that the machinery or related product remains in conformity with this Regulation;

(m)the source code or programming logic of the safety related software to demonstrate the conformity of the machinery or related product with this Regulation further to a reasoned request from a competent national authority provided that is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III;

(n)for sensor-fed, remotely-driven, or autonomous machinery or related products, if the safety related operations are controlled by sensor data, a description, where appropriate, of the general characteristics, capabilities and limitations of the system, data, development, testing and validation processes used;

(o)the results of research and tests on components, fittings or the machinery or related product carried out by the manufacturer to determine whether by its design or construction it is capable of being assembled and put into service safely.

The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the partly completed machinery with the relevant essential health and safety requirements set out in Annex III.

The technical documentation shall include at least the following elements:

(a)a complete description of the partly completed machinery and of its intended function when incorporated into or assembled with machinery or other partly completed machinery or equipment;

(b)the risk assessment documentation showing the procedure carried out, including:

(i)a list of the essential health and safety requirements which apply to the partly completed machinery;

(ii)the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks;

(c)design and manufacturing drawings and schemes of the partly completed machinery and of its components, sub-assemblies and circuits;

(d)the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (c) and of the operation of the partly completed machinery;

(e)the references of the harmonised standards referred to in Article 20(1) or common specifications adopted by the Commission in accordance with Article 20(3) that have been applied for the design and manufacture of the partly completed machinery. In the event of partial application of harmonised standards or common specifications, the documentation shall specify the parts, which have been applied;

(f)where harmonised standards or common specifications have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to meet each applicable essential health and safety requirement;

(g)reports and/or results of the design calculations, tests, inspections and examinations carried out to verify the conformity of the partly completed machinery with the applicable essential health and safety requirements;

(h)a description of the means used by the manufacturer during the production of the partly completed machinery to ensure the conformity of the partly completed machinery produced with the design specifications;

(i)a copy of the assembly instructions for the partly completed machinery set out in Annex XI;

(j)for partly completed machinery produced in series, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied;

(k)the source code or programming logic of the safety related software upon a reasoned request from a competent national authority, provided that is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III;

(l)for sensor-fed, remotely-driven, or autonomous partly completed machinery, if the safety related operations are controlled by sensor data, a description, where appropriate, of the general characteristics, capabilities and limitations of the system, data, development, testing and validation processes used;

(m)the results of research and tests on components, fittings or the partly completed machinery carried out by the manufacturer to determine whether by its design or construction it is capable of being assembled and incorporated safely.