新版LVD低电压指令介绍： 2014/35/EU

为适应欧盟新立法框架（New Legislative Framework，NLF），2014年3月29日，欧盟官方期刊公布了新版本的低电压指令2014/35/EU，用以替换原有的低电压指令2006/95/EC。

新指令将于2016年4月20日起执行。各成员国必须在2016年4月19日前完成立法程序。换言之，符合旧低电压指令的产品2016年4月20日后将不被接受。

新指令旨在确保更为简便的市场准入以及对消费者生命财产更高水平的保护：

1 明确了制造商，进口商和分销商的责任；

2 在符合性证明中电子手段的更广泛应用；

3 通过对缺陷或不安全和产品追朔系统的完善，通过不断完善的对合格性评定机构的制度以及监督，消费者的安全更有保障；

4 更加完善的市场监督机构追踪及阻止危险产品的进口；

Q1低电压指令的范围是什么?

适用于设计的额定电压在交流50~1000伏和直流75~1500伏的电气产品，以下产品除外：

a. 在爆炸环境中使用的电气产品

b. 在辐射或医疗用途中使用的电气产品

c. 货用或客用电梯的电气部件

d. 电表

e. 家用插头和插座

f. 电围栏的控制器

g. 无线电干扰

h. 符合由欧盟成员国参与的国际机构制定的安全规定，使用在船舶，飞机或铁路中的专用电气产品

i. 专业人员使用的，仅用于研发场所的作为研发用途的定制的评估装备

What is the scope of low voltage directive?

Shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than those listed below:

a. Electrical equipment for use in an explosive atmosphere

b. Electrical equipment for radiology and medical purposes

c. Electrical parts for goods and passenger lifts

d. Electricity meters

e. Plugs and socket outlets for domestic use

f. Electric fence controllers

g. Radio-electrical interference

h. Specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

i. Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

Q2.和旧指令相比，新的低电压指令的主要变化是什么？

1）第2条中的新增定义，源自768/2008/EC 附录I的 R1；

2）第6~11条中的对经济运营商的义务的新增要求，源自768/2008/EC 附录I的 R2~R7；

3）第16条中的更具体的关于CE标识的原则，源自(EC)765.2008的第30条；

4）更具体的关于市场监管的要求，第18条，源自(EC)765.2008的第15条点3，第16~29条；第19~22条，源自768/2008/EC 附录I的 R31~R34；

5）附录II中的新增的豁免条款 “专业人员使用的，仅用于研发场所的作为研发用途的定制的评估装备”；

6）附录III中准备技术文件的额外要求 “对风险的充分分析和评估” 源自768/2008/EC 附录II的点2；

7）删除了旧指令中第8条点2,3和第11条中欧盟公告机构需要提供支持的要求。

What is the main change of the new low voltage directive comparing with the old directive?

1) New definitions in article 2 - from 768/2008/EC Annex I R1;

2) New requirement of the obligations of economic operators in Article 6~11 - from 768/2008/EC Annex I R2~R7;

3) More detailed principle of CE marking in article 16 – from (EC)765.2008 Article 30;

4) More detailed requirement of market surveillance in Article 18 - from (EC)765/2008 Article 15(3), Article 16~29; Article 19~ 22 – from 768/2008/EC Annex I R31~ R34;

5) New exemption item in Annex II: “Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes”;

6) Additional requirement of preparation of technical documentation for “adequate analysis and assessment of the risk(s)” in Annex III – from 768/2008/EC Annex II point 2;

7) Delete the requirement of support from notified body in Article 8(2), 8(3), and11 in old directive.

Q3.什么是低电压指令的安全目标？

电气产品在按照它的预期用途正确的安装，维护和使用时，不能危及人类和家养动物健康和安全，或危及财产。

What is the safety objective of low voltage directive?

Electrical equipment does not endanger the health and safety of persons and domestic animals, or property, when properly installed and maintained and used in applications for which it was made.

Q4.如何识别产品，制造商和进口商？

1）制造商应确保产品上标有型号、批次或序列号或其他可以识别的要素，或者如果不可能，应标在包装或随附文件上；

2）制造商应在产品上显示制造商的名称、注册的商标名称或商标标志和邮政地址，或者如果不可能，应标在包装或随附文件上。地址应当是单一地点；

3）进口商应在产品上显示进口商的名称、注册的商标名称或商标标志和邮政地址，或者如果不可能，应标在包装或随附文件上。

How to identify the product, manufacturer and importer?

1) Manufacturers shall ensure product bears a type, batch or serial number or other element for identification or not possible, on the packaging or accompanying document ;

2) Manufacturers shall indicate manufacturer’s name, registered trade name or trade mark and postal address on the product, or not possible, on the packaging or accompanying document. The address shall indicate a single point;

3) Importer shall indicate importer’s name, registered trade name or trade mark and postal address on the product, or not possible, on the packaging or accompanying document.

Q5.如何符合低电压指令？

通过制造商的符合性评估程序：内部生产控制（模式A）

1）准备包括充分风险分析和评估的技术文件；

2）制造流程和它的监督应确保所制造的产品符合技术文件的规定；

3）起草欧盟符合性声明（DoC）；

4）张贴CE标识。

How to comply with the low voltage directive?

By conformity assessment procedure: Internal production control (module A) by manufacturers

1) Technical documentation which includes an adequate analysis and assessment of the risk(s);

2) Manufacturing process and its monitoring shall ensure compliance of the manufactured product with the technical documentation;

3) Drawing up of EU declaration of conformity (DoC);

4) Affixing of CE marking.

Q6.“技术文件”应包括哪些内容？

1）充分的风险分析和评估；

2）电气产品的总体描述；

3）设计理念和制造图纸，以及零部件、组装件的明细等；

4）为理解对应的图纸和明细以及电气产品的工作所需的必要的描述和解释；

5）全部或部分应用的协调标准，或，或国家标准的清单，以及在没有使用协调标准或或国家标准的情况下，为符合指令的安全目标所采用的解决方案的描述，包括所应用的其他相关技术规范的清单。如果部分应用了协调标准或或国家标准，技术文件中应指明所应用的部分；

6）所作的设计计算和检验的结果等；

7）检测报告。

What shall be included in “Technical documentation”?

1) An adequate analysis and assessment of the risk(s);

2) A general description of the electrical equipment;

3) Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

4) Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;

5) A list of the harmonised standards applied in full or in part or international or national standards and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or international or national standards, the technical documentation shall specify the parts which have been applied;

6) Results of design calculations made, examinations carried out, etc.;

7) Test reports.

Q7.“风险分析和评估”怎么做？

1）制造商应负责建立正确的风险评估（程序和文件）；

2）制造商可以参考EN31010:2010 (IEC/ISO31010:2009) 中提及的针对风险管理的风险评估技术或其他适用的方法；ISO/TR 14121-2指导制造商在风险分析和评估中可以使用分组合作方案；

3）制造商应保存文件化的证据显示对附录I（安全目标的要素）的符合性；

4）如果制造商不能向市场监管机构提供风险评估的资料，将会导致相应的处罚。

What to do for the “analysis and assessment of the risk”?

1) Manufacturer is responsible that the risk assessment (test procedure and document) is established in the right way;

2) Manufacturer may refer to the risk assessment techniques for risk management described in EN 31010:2010 (IEC/ISO 31010:2009) or other applicable method; ISO/TR 14121-2 guides the manufacturer may use the team approach for risk analysis and assessment;

3) Manufacturer shall have documented evidence that Annex I (principal elements of the safety objectives) is fulfilled;

4) If manufacturer can’t provide a risk assessment to the market authorities, penalties are possible.