欧盟机械指令进版

欧盟机械指令进版

WILL YOU BE COMPLIANT BY 29TH DECEMBER 2009? 您在2009年12月29日之前满足要求了吗？

Why you need to act now 为什么你现在就要行动

If your company manufactures products that fall within the scope of the Machinery Directive (MD) or you are an agent (2) for such products, there is a major change imminent. The consequences of which could seriously affect your ability to do business in the European Community.
如果您制造或者代理的产品属于机械指令（MD）的范围内，很快您将面临一个重大的改变，而且会影响到您在欧盟市场上的业务能力。

On 29th December 2009, the newly revised MD 2006/42/EC replaces MD 98/37/EC which has been mandatory since January 1995. It sets out the essential health and safety requirements for machinery within the European Community. The term ‘machinery’ generally covers any equipment, whether for domestic, commercial or industrial use, that has parts actuated by a power source other than manual effort. Excluded from the MD are machines where the risks are wholly covered by other EC Directives.
2009年12月29日，新修订的MD 2006/42/EC将取代自1995年1月起就强制实施的MD 98/37/EC。它规定了在欧盟市场上的机械产品必须满足基本的健康和安全要求。术语“机械”涵盖了任何设备，不管是出于家庭用途、商业用途还是工业用途，只要它有部分是靠能源而不是靠手动驱动的，就属于“机械”范围。但如果机器的风险完全被其他欧盟指令所该覆盖，那则排除在MD外。

The purpose of the Directive is to harmonise national laws of member states and this new version addresses many of the interpretational issues that have arisen from the process of consolidating previous versions of the MD. It also expands the list of hazardous machinery and equipment products falling within Annex IV applying to hazardous machinery and equipment.
机械指令的目的是协调各成员国的法律，而且新版本解决了合并旧版本过程中出现的很多解释上的问题。它还扩大了相应附录IV中危险机械和设备产品的范围。

The new Directive has a broadened scope which includes:
新版指令扩大了范围，包括：
 §       Interchangeable equipment 可互换设备
 §       safety components 安全部件
 §       lifting accessories 起重附件
 §       chains, ropes and webbing 链条、缆索及织带
 §       removable mechanical transmission devices 机械传动可移动装置
 §       partly completed machinery 只完成部分的机械

As a manufacturer or agent, from 29th December 2009, you must comply with the new MD or risk having your goods excluded from the European Community. All machinery and safety components falling within the scope of the Directive must be subjected to an appropriate conformity assessment procedure before they can be legally placed on the market. Each procedure will, as a minimum, require you to:
作为制造商或代理商，从2009年12月29日起，您必须符合新的MD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：
- establish technical documentation demonstrating how the product satisfies the essential health and safety requirements; 编写技术文件以表明产品符合基本的健康和安全要求；
- prepare and issue a declaration of conformity; 编制并发布符合性声明；
- affix the CE marking. 贴CE标志。

There will be no transition period between the old and the new Directive. As a result, a product which currently complies with MD 98/32/EC may overnight become non-compliant. Unless you are proactive in ensuring compliance, the new MD could have a significant impact upon your business.
新旧版本指令之间不存在过渡期。因此，目前符合MD 98/32/EC要求的产品可能突然就变成不符合了。除非您在确保符合性方面非常主动，否则新的MD对您业务将产生重大影响。

(2) The term Agent could mean an Authorised Representative, Importer or Distributor
(2)术语代理商可以指授权代表、进口商或经销商。

The steps you need to take to comply 您需要做什么以符合新的指令

With a deadline of 29th December 2009 for bringing all machinery and safety components within the scope of the new Machinery Directive, as a manufacturer, you are recommended to review your products without delay. You may then want to adapt them and their technical documentation, commonly called the ‘technical file’, to take account of the requirements.
由于2009年12月29日是所有机械和安全部件纳入新版指令的最后期限，我们建议您及时评审您制造的产品，看是否需要对产品或者技术文件（通称为“技术文档”）进行调整，以满足指令要求。

But first it is necessary to decide whether your products are considered hazardous. The Directive identifies machinery as:
劳氏验证有限公司（LRV）是受欧盟认可的授权机构（Notified Body），拥有帮助制造商及其代理商满足MD要求的丰富经验。我们可以帮助您简化符合的过程或作为授权机构为您进行认证。我们的服务包括：
 §       the review and issue certificates of adequacy for Technical Files; 技术文档充足性的评审和认证；
 §       conducting EC type examinations for Annex IV products, including associated inspection and witnessed test activities (Module B); 对附录IV的产品进行EC型式试验，包括相关的检验和试验的现场见证（模式B）；
 §       providing a full quality assurance assessment (Module H) (New for MD 2006/42/EC 提供全面质量保证审核（模式H）（MD 2006/42/EC中新增的内容）。

Lloyd’s Register Verification Ltd. is a recognised notified body with extensive experience of helping manufacturers and their agents to successfully comply with the MD. We can help to ease the process or act as your notified body. Our services include:
但首先您必须确认您的产品是否是危险设备。机械指令把机械分为：

 §       Hazardous machinery and safety components (as explicitly listed in Annex IV of the MD)
Examples include circular saws and other hazardous woodworking tools, presses for the cold working of metals, injection and compression moulding equipment. These products must be submitted to a notified body, such as Lloyd’s Register Verification Ltd.,  to undertake an EC type examination or a full quality assurance assessment. The manufacturer or agent must then prepare a declaration of conformity and affix the CE marking.
 §       危险的机械和安全部件（如MD的附录IV明确列出的）
这包括：圆锯和其他危险的木工工具、金属冷加工的压榨机、注塑成型设备。这一类产品必须由授权机构，如劳氏验证有限公司，进行EC型式试验或全面质量保证审核。制造商或代理商必须就此编制一份符合性声明，并贴上CE标志。

 §       All other machinery and safety components that fall within the scope of the MD
Here, the manufacturer or agent may complete the assessment of conformity themselves by preparing the technical documentation, a declaration of conformity and affixing the CE marking. If there are doubts about any aspects of conformity and a second opinion would be helpful, Lloyd’s Register Verification Ltd. can review the technical documentation and issue a certificate of adequacy.
 §       所有其他属于MD范围的机械和安全部件
这一类产品的制造商或代理商可以自行完成符合性审核，要做的是准备技术文件、编制符合性声明并贴上CE标志。如果您对符合性的某些方面有疑问且需要第二方意见进行定夺，劳氏验证有限公司可以给予您帮助。它可以帮您评审技术文件，并出具文件充足证明。

The next steps will include:
1．        Review the design of your product against the new essential health and safety requirements and/or revised harmonised standards to determine extent of conformity;
2．        Update as necessary the technical documentation to reflect the above tasks; and
3．        Once you have decided whether or not your product is deemed hazardous, follow the appropriate conformity assessment procedure (refer to the flow chart on Page 5
接下来的步骤包括：
4．        根据新的基本健康和安全要求和/或修订的协调标准对产品的设计进行审查，以确定符合性程度；
5．        必要时更新技术文件，以完成上述任务；
6．        一旦确定您的产品是否被认为具有危险性的，要遵照适当的符合性审核程序（参考第5页的流程图）

Conformity assessment procedures 符合性审核程序

Article 12: procedure for assessing the conformity of machinery
第12章：审核机械符合性的程序

The key elements of Annex IV 附录IV的要素

Technical Documentation
This documentation must demonstrate how the product satisfies the relevant essential health and safety requirements. As a manufacturer you are responsible for determining which of these requirements, as detailed in Annex 1 of the MD, apply to your products and how your products meet those requirements. The technical documentation must relate to the design, manufacture and operation of the product.
技术文件
文件必须表明产品是如何满足相关的基本健康和安全要求的。作为制造商，您有责任确定MD附录1中列出的要求有哪些适用于您的产品，以及您的产品是如何满足这些要求的。技术文件必须涉及产品的设计、生产和操作。

Full Quality Assurance Module
This is a new conformity assessment procedure option in the MD and is most suited to manufacturers who produce a variety of products or may want to introduce new products on a regular basis. In this case, the Full QA Module is likely to be your most cost effective route as it is based on an assessment of your capability to design and build a particular type of product. With this module you will be subject to ongoing surveillance to ensure conformity is maintained.
全面质量保证模式
这是MD中可供选择的新的符合性审核程序，最适用于生产多种不同产品的或定期推出新产品的制造商。在这种情况下，全面质量保证模式有可能成为您最具有成本效益的途径，因为它以审核您设计并制造某一类型产品的能力为基础。采用这种模式，您将可以得到不间断的监督，以确保符合性得以维护。

At the EBO certificate center, we can provide assessment services which satisfy the requirements of the new MD.
EBO可以提供审核服务，让您满足新MD的要求。

EC Type Examination
This is an alternative conformity assessment procedure available to manufacturers of Annex IV products. With this procedure, the technical documentation is independently reviewed for conformity with the relevant essential health and safety requirements and/or harmonised standards. In addition, an example of the product will be subjected to witnessed inspection and test against the technical documentation. This procedure will appeal if you mass produce a single type of product or a one off design.
EC 型式试验
这是可为生产附录IV产品的制造商所用的另一个符合性审核程序。采用这种程序，将进行独立的技术文件审查，以确定是否符合相关的基本健康和安全要求及/或协调标准要求。另外，要根据技术文件对产品样品进行现场见证检验和测试。如果您大规模生产单一类型的产品或设计，您可以采用此程序。

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