DIRECTIVE 2006/42/EC ANNEX VII

ANNEX VII
A. Technical file for machinery   技術文件  
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.

1. The technical file shall comprise the following:技術文件必須包括:(a)產品結構檔案\(b)系列生產
(a) a construction file including:產品結構檔案
    — a general description of the machinery,機械描述
    — the overall drawing of the machinery機械圖 and drawings of the control circuits電路圖,
       as well as the pertinent descriptions and explanations necessary for understanding the
       operation of the machinery,
    — 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,證明符合的一切圖\計算\測試\證明文件
    — the documentation on risk assessment demonstrating the procedure followed, including:風險評估執行過程
       (i) a list of the essential health and safety requirements 查檢表 which apply to the machinery,
       (ii) the description of the protective measuresimplemented to eliminate
            identified hazards or to reduce risks and, when appropriate, the indication of
            the residual risks associated with the machinery,安全保護措施與殘餘風險
    — the standards and other technical specifications used,indicating the essential health and safety
       requirements covered by these standards,
       使用的標準與其他技術規格證實essential health and safety requirements規定已被涵蓋
    — 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,
       工廠\工廠選定團體\或授權指定代表執行之測試或技術報告
    — a copy of the instructions for the machinery,說明書
    — where appropriate, the declaration of incorporation for included partly completed machinery and the
       relevant assembly instructions for such machinery,半成品零件宣告書\說明書
    — where appropriate, copies of the EC declaration of conformity of machinery or other products
       incorporated into the machinery,配合使用之產品EC宣告書
    — a copy of the EC declaration of conformity;EC宣告書
(b) for series manufacture, the internal measures that will be implemented to ensure 系列生產
    that the machinery remains in conformity with the provisions of this Directive.
    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.
    系列生產,工廠內部方法必須確保該機械仍符合本指令要求
    工廠必須執行必要研發與零件測試,以確保完整機械設計與結構可被安全使用
    上述相關報告與結果必須存檔於技術文件檔案中


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. 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. 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.
技術文件必須至少保存10年

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.
競爭授權代表反映任何上述文件之失效,可構成懷疑essential health and safety requirements之符合姓


B. Relevant technical documentation for partly completed machinery部品零件技術文件
This part describes the procedure for compiling relevant technical documentation. The documentation must show
which requirements of this Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.
It shall comprise the following:
(a) a construction file including:
— the overall drawing of the partly completed machinery and drawings of the control circuits,
— full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,
— the risk assessment documentation showing the procedure followed, including:零件風險評估包括
(i) a list of the essential health and safety requirements applied and fulfilled,
(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,
(iii) the standards and other technical specifications used, indicating the essential health and safety requirements
covered by these standards,
(iv) 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,
(v) a copy of the assembly instructions for the partly completed machinery;
(b) for series manufacture, 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.
The manufacturer must carry out necessary research and tests on components, fittings or the partly completed
machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.
The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States. It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.