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DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)

 

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ANNEX VII 机械技术文件要求

A.     Technical file for machinery机械的技术文件

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.

本部分描述了编制技术文件的程序。技术文件必须说明机械满足本指令的要求,必须包括合格评定必需的机械的设计、制造和操作。除了机械的说明书适用附录I 1.7.4.1 中的特别条款外,技术文件必 须用一种或多种共同体官方语言编写。

1.      The technical file shall comprise the following:技术文件应包含以下内容:

(a)    a construction file including:结构文件,包含:

A general description of the machinery,机械的总描述,

  The overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,机械的总体图、控制电路图,以及理解机器操作所必需的描述和解释,

Full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,检查机械是否符合基本健康与安全要求所需的详细图样及计算记录, 试验结果、 证书等,

The documentation on risk assessment demonstrating the procedure followed, including:

说明风险评价程序的文档,包括:

(i)      A list of the essential health and safety requirements which apply to the machinery,

适用于该机械的基本健康与安全要求列表,

(ii)     The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,消除已经识别危险或减小风险的保护措施描述,必要时指出机械的遗留风险。

The standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, 使用的标准和其他技术规范,指出这些标准涵盖的基本健康和安全要求,

Any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,给出制造商或者制造商或其授权代表选定机构进行的试验结果的技术报告,

A copy of the instructions for the machinery,机械的说明书副本

Where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery, 适当时,包括半成品机械的组装声明和此类机械的相关装配说明

Where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,适当时,机械的EC 合格声明副本或组装在机械内的其他产品,

A copy of the EC declaration of conformity; EC合格声明的副本;

(b)    For series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.

对于成批生产,为确保机械始终符合本指令相关条款而将实施的内部措施。

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.制造商必须对组件、配件或已完成机械进行必要的研究和试验,以决定机械的设计或制造是否能够保证安全组装和投入使用。技术文件应包括相关的报告和结果。

2.      The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.

上述第 1点所述的文件至少须保存    10 年,并能随时供各成员国主管当局备查, 10 年保存期应从机械制造之日起,如果是成批生产,则从最后一台机械的生产之日起。

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.技术文件不必放在共同体范围内也不要求必须以实物形式永久保存。但是必须能将汇集起来,并视其复杂程度在一定时间内必须由EC合格声明中的指定人员提供。

 

The technical file does not have to include detailed plans or any other specific information as regards the subassemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. 技术文件不必包括详细计划或任何关于制造机械所用组件其他特定信息,除非了解它们对于验证 是否满足基本健康和安全要求是必要的。

3.      Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.

对于各国主管机构提出的合理要求而制造商不能提供技术文件予以满足时,则可能有充分的理由怀疑该机械不符合本指令的基本健康与安全要求。

 

 

了解更多:

MD认证 

机械CE认证

EN 60204-1: 2018机械电气安全要求

MD机械指令 2006/42/EC ANNEX VII技术文件要求