LVD低電壓指令

為適應(yīng)歐盟新立法框架（New Legislative Framework，NLF），2014年3月29日，歐盟官方期刊公布了新版本的低電壓指令2014/35/EU，用以替換原有的低電壓指令2006/95/EC。

新指令將于2016年4月20日起執(zhí)行。各成員國必須在2016年4月19日前完成立法程序。換言之，符合舊低電壓指令的產(chǎn)品2016年4月20日后將不被接受。

新指令旨在確保更為簡便的市場準(zhǔn)入以及對消費者生命財產(chǎn)更高水平的保護：

1 明確了制造商，進(jìn)口商和分銷商的責(zé)任；

2 在符合性證明中電子手段的更廣泛應(yīng)用；

3 通過對缺陷或不安全和產(chǎn)品追朔系統(tǒng)的完善，通過不斷完善的對合格性評定機構(gòu)的制度以及監(jiān)督，消費者的安全更有保障；

4 更加完善的市場監(jiān)督機構(gòu)追蹤及阻止危險產(chǎn)品的進(jìn)口；

Q1低電壓指令的范圍是什么?

適用于設(shè)計的額定電壓在交流50~1000伏和直流75~1500伏的電氣產(chǎn)品，以下產(chǎn)品除外：

a. 在爆炸環(huán)境中使用的電氣產(chǎn)品

b. 在輻射或醫(yī)療用途中使用的電氣產(chǎn)品

c. 貨用或客用電梯的電氣部件

d. 電表

e. 家用插頭和插座

f. 電圍欄的控制器

g. 無線電干擾

h. 符合由歐盟成員國參與的國際機構(gòu)制定的安全規(guī)定，使用在船舶，飛機或鐵路中的專用電氣產(chǎn)品

i. 專業(yè)人員使用的，僅用于研發(fā)場所的作為研發(fā)用途的定制的評估裝備

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.和舊指令相比，新的低電壓指令的主要變化是什么？

1）第2條中的新增定義，源自768/2008/EC 附錄I的 R1；

2）第6~11條中的對經(jīng)濟運營商的義務(wù)的新增要求，源自768/2008/EC 附錄I的 R2~R7；

3）第16條中的更具體的關(guān)于CE標(biāo)識的原則，源自(EC)765.2008的第30條；

4）更具體的關(guān)于市場監(jiān)管的要求，第18條，源自(EC)765.2008的第15條點3，第16~29條；第19~22條，源自768/2008/EC 附錄I的 R31~R34；

5）附錄II中的新增的豁免條款 “專業(yè)人員使用的，僅用于研發(fā)場所的作為研發(fā)用途的定制的評估裝備”；

6）附錄III中準(zhǔn)備技術(shù)文件的額外要求 “對風(fēng)險的充分分析和評估” 源自768/2008/EC 附錄II的點2；

7）刪除了舊指令中第8條點2,3和第11條中歐盟公告機構(gòu)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.

Q3.什么是低電壓指令的安全目標(biāo)？

電氣產(chǎn)品在按照它的預(yù)期用途正確的安裝，維護和使用時，不能危及人類和家養(yǎng)動物健康和安全，或危及財產(chǎn)。

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.如何識別產(chǎn)品，制造商和進(jìn)口商？

1）制造商應(yīng)確保產(chǎn)品上標(biāo)有型號、批次或序列號或其他可以識別的要素，或者如果不可能，應(yīng)標(biāo)在包裝或隨附文件上；

2）制造商應(yīng)在產(chǎn)品上顯示制造商的名稱、注冊的商標(biāo)名稱或商標(biāo)標(biāo)志和郵政地址，或者如果不可能，應(yīng)標(biāo)在包裝或隨附文件上。地址應(yīng)當(dāng)是單一地點；

3）進(jìn)口商應(yīng)在產(chǎn)品上顯示進(jìn)口商的名稱、注冊的商標(biāo)名稱或商標(biāo)標(biāo)志和郵政地址，或者如果不可能，應(yīng)標(biāo)在包裝或隨附文件上。

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.如何符合低電壓指令？

通過制造商的符合性評估程序：內(nèi)部生產(chǎn)控制（模式A）

1）準(zhǔn)備包括充分風(fēng)險分析和評估的技術(shù)文件；

2）制造流程和它的監(jiān)督應(yīng)確保所制造的產(chǎn)品符合技術(shù)文件的規(guī)定；

3）起草歐盟符合性聲明（DoC）；

4）張貼CE標(biāo)識。

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.“技術(shù)文件”應(yīng)包括哪些內(nèi)容？

1）充分的風(fēng)險分析和評估；

2）電氣產(chǎn)品的總體描述；

3）設(shè)計理念和制造圖紙，以及零部件、組裝件的明細(xì)等；

4）為理解對應(yīng)的圖紙和明細(xì)以及電氣產(chǎn)品的工作所需的必要的描述和解釋；

5）全部或部分應(yīng)用的協(xié)調(diào)標(biāo)準(zhǔn)，或國際標(biāo)準(zhǔn)，或國家標(biāo)準(zhǔn)的清單，以及在沒有使用協(xié)調(diào)標(biāo)準(zhǔn)或國際標(biāo)準(zhǔn)或國家標(biāo)準(zhǔn)的情況下，為符合指令的安全目標(biāo)所采用的解決方案的描述，包括所應(yīng)用的其他相關(guān)技術(shù)規(guī)范的清單。如果部分應(yīng)用了協(xié)調(diào)標(biāo)準(zhǔn)或國際標(biāo)準(zhǔn)或國家標(biāo)準(zhǔn)，技術(shù)文件中應(yīng)指明所應(yīng)用的部分；

6）所作的設(shè)計計算和檢驗的結(jié)果等；

7）檢測報告。

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.“風(fēng)險分析和評估”怎么做？

1）制造商應(yīng)負(fù)責(zé)建立正確的風(fēng)險評估（程序和文件）；

2）制造商可以參考EN31010:2010 (IEC/ISO31010:2009) 中提及的針對風(fēng)險管理的風(fēng)險評估技術(shù)或其他適用的方法；ISO/TR 14121-2指導(dǎo)制造商在風(fēng)險分析和評估中可以使用分組合作方案；

3）制造商應(yīng)保存文件化的證據(jù)顯示對附錄I（安全目標(biāo)的要素）的符合性；

4）如果制造商不能向市場監(jiān)管機構(gòu)提供風(fēng)險評估的資料，將會導(dǎo)致相應(yīng)的處罰。

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.