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欧盟新版机械指令2006/42/EC 12月29日将强制实行
发布时间:[2010-02-19]  阅读次数:[5714]次   双击自动滚屏

   欧盟新版机械指令2006/42/EC 将于2009年12 月29 日起生效执行(例外:唯有可携带式匣带加工机械或具有挤压功能的加工机匣,可以到2011年6月29日才实施),取代现行的机械指令98/37/EC,且无缓冲过渡期。据官方的文件,只有在12月29日之后,才能建立一份根据指令2006/42/EC的声明

    新版指令有许多差异,对销往欧盟的机械制造商与经销商将造成较大影响。

新版机械指令2006/42/EC的主要变化:

    新版机械指令2006/42/EC和旧版机械指令98/37/EC的主要区别在于指令的适用范围,基本健康和安全要求,定义以及符合性评估程序和市场监督方面。

    1、新指令适用范围增加了半成品,举升附件等;

     (a) machinery 机械设备;
     (b) interchangeable equipment 可互换性设备;
     (c) safety components 安全零组件;
     (d) lifting accessories 升降机附件;
     (e) chains, ropes and webbing 链条、绳索、丝网;
     (f) removable mechanical transmission devices 可拆卸的机械传动装置;
     (g) partly completed machinery 机械半成品机械装置.

    2、新指令附录I基本健康和安全同老指令存在一些技术差异,如噪音声压值80dB需标出声功率值;

    3、新指令增加了更多术语明确的定义如半成品,制造商;

    4、评估程序,新指令不在使用“storage option”模式,只接收下列中的一个模式:

     (a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII 自我宣告;
     (b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3 EC 型式验证;
     (c) the full quality assurance procedure provided for in Annex X 全面质量保证模试.

    5、机械指令2006/42/EC对于附录四(Annex IV)中危险机械的产品清单进行了更新,在98/37/EC指令中17种危险机械的基础上增加到23种;同时对于98/37/EC Annex IV part B部分的安全机械部件,在2006/42/EC中单独以附录五(Annex V)的形式列出,由原来的5个安全部件增加到17类产品,通过更新目录及限制进入欧盟市场进行控制。

    6、新指令要求半成品投入市场需达到以下要求并随同半成品一起提供直到成品完成:
     (a) the relevant technical documentation described in Annex VII, part B is prepared 编制附录VII B的技术文件;
     (b) assembly instructions described in Annex VI are prepared 附录VI描述的装配说明书;
     (c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up 宣告.

    7、加强了市场监督力度:

    由于目前不合法的CE证书或宣告太多,许多带有CE标志的机械产品并没有达到相关欧盟指令的要求,新版机械指令加强市场监督力度。不论是欧盟各国的制造商,还是外国所制造而销往欧盟境內的机械制造商,为了方便欧盟CE监督机构的监督工作有效进行,新版机械指令规定:在制造商的宣告文件中必须要有制造商授权编制整套TCF技术文件的负责人名称及联络地址,并且此人必须被确定在欧盟境内。(原文:The EC declaration of conformity must contain the following particulars: name and address of the person authorised to compile the technical file, who must be established in the Community。) 也就是说,一但欧盟CE监督机构发现CE证书或宣告存在虚假迹象,机械产品没有达到相关欧盟指令的要求或机械产品出现了安全事故时,他们能够立即在欧盟境內联系到此负责人,此人代表制造商与欧盟当局处理CE相关事宜。

新版机械指令2006/42/EC已公布的新标准:

欧盟委员会已委派欧洲电工标准化委员会(CENELEC)发展新标准以确保现行标准可以按照新版机械指令2006/42/EC查验并做必要的改编。此外,所有协调标准必须包含对新指令的一个参照。具体请查看附件2006/42/EC指令下已公布的标准,新指令协调标准即将发布具体查看以下链接:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/machines.html

中包标准如何协助您?

    作为制造商或代理商,从2009年12月29日起,您必须符合新的机械指令的要求,否则将面临产品被排除在欧盟市场外的风险。属于该指令范围的所有机械和安全部件必须进行适当的符合性审核程序评定才能合法地投放于市场。每个程序将至少要求您:

◆ 编写技术文件以表明产品符合基本的健康和安全要求;
◆ 编制并发布EC符合性声明;
◆ 贴CE标志.
◆ 免费更换中包标准认证的新证书

关于新机械指令2006/42/EC的一些问题(FAQ)

1. Question:--关于过渡期

Is there a transition period for application of Directive 2006/42/EC?

Answer :
    In general, there is no transition period, in the sense of a period during which both the current Machinery Directive and the new Machinery Directive are applicable (with one exception: there isa transition period until 29th June 2011 for the particular case of portable cartridge-operated fixing and other impact machinery).However there is a period of adaptation, since the provisions o the Directive 2006/42/EC become applicable on 29th December 2009. During this period, all of the stakeholders concerned will be able to take the necessary steps to ensure a smooth transition from the current Directive to the new Directive.

2. Question:--关于是否使用新旧指令

Can manufacturers anticipate application of the new Machinery Directive?

Answer:
    Yes and no. Manufacturers can and should anticipate application of Directive 2006/42/EC from a practical and technical point of view, however, from a formal, legal point of view, the Directive cannot be applied before 29th December 2009:

    - From the practical and technical point of view, manufacturers are encouraged to review their products without delay and adapt them as necessary to take account of the requirements of the new Directive. While machinery placed on the market before 29th December 2009 must continue to comply with Directive 98/37/EC, it can be assumed that a product that complies with the essential requirements of the new Machinery Directive continues to comply with the current Directive.

    - From the formal, legal point of view, machinery can only be placed on the market with reference to Directive 2006/42/EC as from 29th December 2009.

3. Question:---满足新指令宣告

When shall a manufacturer establish an EC Declaration of conformity according to Directive 2006/42/EC?

Answer:
    A manufacturer shall establish an EC Declaration of conformity according to Directive 2006/42/EC for products first placed on the market as from 29th December 2009. In cases where the manufacturer cannot be certain on what date individual products will be first placed on the market, providing the products concerned comply with both the current and the new Directives,he may establish an EC Declaration of conformity referring to both Directive 98/37/EC and Directive 2006/42/EC. The reference to Directive 98/37/EC should be removed from theEC Declaration of conformity after the 29th December 2009.

4. Question:---关于旧指令的协调标准新指令是否适用

Can the current harmonised standards be used to comply with Directive 2006/42/EC?

Answer: 
    Since there have been some modifications to the essential health and safety requirements set out in Annex I, it cannot be assumed that the current harmonised standards comply fullywith Directive 2006/42/EC.

    The European Commission is issuing a mandate to CEN and Cenelec to develop the necessary new standards and ensure that the current standards are checked against Directive 2006/42/EC and adapted as necessary. Furthermore, all harmonised standards must include a reference to the new Directive.

    The Commission intends to publish a list of harmonised standards supporting Directive 2006/42/EC before the Directive becomes applicable.

5. Question:--关于附录IV产品,制造商何时可以使用全新的质量保证程序

When will manufacturers be able to use the new full quality assurance procedure for Annex IV machinery?

Answer:
    The Member States will first have to assess, appoint and notify Notified Bodies for the new full quality assurance procedure set out in Annex X of the new Directive. This can be done as soon as Directive 2006/42/EC has been transposed into national law.

    As soon as Bodies have been notified for this procedure, they will be able to carry out the necessary audits and inspections and issue approvals of manufacturers’ full quality assurance systems. However,products cannot be placed on the market on the basis of such approvals until Directive 2006/42/EC becomes applicable on 29th December 2009.

6. Question:--关于现有的NB能否做新指令的型式认证

Will the existing Notified Bodies be able to carry out EC type-examinations according to Directive 2006/42/EC?

Answer:
    Bodies that are notified to carry out EC type-examinations under Directive 98/37/EC will be able to continue to carry out EC type-examinations under Directive 2006/42/EC, providing theirnotification covers the product categories concerned.

    For product categories included in Annex IV of Directive 2006/42/EC that are not listed in Annex IV of Directive 98/37/EC, the Member States will have to notify new Bodies or extend the scope of the notification of existing ones.

7. Question:--关于按旧指令做的型式认证是否适用于新指令

Will EC type-examination certificates established according to Directive 98/37/EC remain valid for Directive 2006/42/EC?

Answer:
    Since there have been some modifications to the essential health and safety requirements set out in Annex I, it cannot be assumed that EC type-examination certificates issued according to Directive 98/37/EC remain valid for Directive 2006/42/EC. Furthermore, such certificates must be updated to refer to Directive 2006/42/EC..

    Notified Bodies will thus have to review existing EC type-examination certificates to ensure that they remain valid in light of the requirements of the new Directive and update them to refer to Directive 2006/42/EC. Manufacturers are encouraged to request this review without delay in order to avoid a bottleneck in the months preceding December 2009.

    Since Directive 2006/42/EC requires EC type-examination certificates to be reviewed every 5 years (see Annex IX, section 9.3), the 5-year period for existing certificates can be counted from the date on which they have been updated according to Directive 2006/42/EC.

8. Question:What will happen to products certified according to one of the procedures set out in Article 8 (2) (c) of Directive 98/37/EC (Receipt of techncial file or Certificate of adequacy to harmonised standards)?

Answer:
    The procedures set out in Article 8 (2) (c) of Directive 98/37/EC will no longer exist under Directive 2006/42/EC. As from 29th December 2009, manufacturers of products placed on the market on the basis of these procedures will therefore have to apply one of the procedures set out in Article 12 (3) and (4) of Directive 2006/42/EC.

    For products manufactured in accordance with harmonised standards that cover all the relevant health and safety requirements, the manufacturer will be able to certify the conformity of the product himself according to the procedure set out in Article 12 (3) (a) of the Directive.

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