安規(guī)就是產(chǎn)品認(rèn)證中對(duì)產(chǎn)品安全的要求，包含產(chǎn)品零件的安全的要求、組成成品后的安全要求。安規(guī)其實(shí)是中國(guó)人自己的產(chǎn)物，國(guó)外一般會(huì)叫成regatory。

新版LVD低電壓指令介紹：2014/35/EU

為適應(yīng)歐盟新立法框架（New LegislativeFramework，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(guó)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(jiǎn)便的市場(chǎng)準(zhǔn)入以及對(duì)消費(fèi)者生命財(cái)產(chǎn)更高水平的保護(hù)：

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(guò)對(duì)缺陷或不安全和產(chǎn)品追朔系統(tǒng)的完善，通過(guò)不斷完善的對(duì)合格性評(píng)定機(jī)構(gòu)的制度以及監(jiān)督，消費(fèi)者的安全更有保障；

4更加完善的市場(chǎng)監(jiān)督機(jī)構(gòu)追蹤及阻止危險(xiǎn)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(jì)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(wú)線電干擾

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

i.人員使用的，僅用于研發(fā)場(chǎng)所的作為研發(fā)用途的定制的評(píng)估裝備

What is thescope of low voltage directive?

Shall apply to electricale designed for use with a voltage rating of between 50 and1 000 V for alternating current and between 75 and 1 500 V fordirect current, other than those listed below:

a. Electrical e for usein an explosive atmosphere

b. Electrical e forradiology and medical purposes

c. Electrical parts for goods andpassenger lifts

d. Electricity meters

e. Plugs and socket outlets fordomestic use

f. Electric fencecontrollers

g. Radio-electricalinterference

h. Specialised electricale, for use on ships, aircraft or railways, which complieswith the safety provisions drawn up by international bodies inwhich the Member States participate.

i. Custom built evaluation kitsdestined for professionals to be used solely at research anddevelopment 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(duì)經(jīng)濟(jì)運(yùn)營(yíng)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(shí)的原則，源自(EC)765.2008的第30條；

4）更具體的關(guān)于市場(chǎng)監(jiān)管的要求，第18條，源自(EC)765.2008的第15條點(diǎn)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“人員使用的，僅用于研發(fā)場(chǎng)所的作為研發(fā)用途的定制的評(píng)估裝備”；

6）附錄III中準(zhǔn)備技術(shù)文件的額外要求 “對(duì)風(fēng)險(xiǎn)的充分分析和評(píng)估”源自768/2008/EC 附錄II的點(diǎn)2；

7）刪除了舊指令中第8條點(diǎn)2,3和第11條中歐盟公告機(jī)構(gòu)需要提供支持的要求。

What is the mainchange of the new low voltage directive comparing with the olddirective?

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

2) New re of theobligations of economic operators in Article 6~11 - from768/2008/EC Annex I R2~R7;

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

4) More detailed re ofmarket surveillance in Article 18 - from (EC)765/2008 Article15(3), Article 16~29; Article 19~ 22 – from 768/2008/EC Annex IR31~ R34;

5) New exemption item in AnnexII: “Custom built evaluation kits destined for professionals to beused solely at research and development facilities for suchpurposes”;

6) Additional re ofpreparation of technical documentation for “adequate analysis andassessment of the risk(s)” in Annex III – from 768/2008/EC Annex IIpoint 2;

7) Delete the re ofsupport from notified body in Article 8(2), 8(3), and11 in olddirective.

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(hù)和使用時(shí)，不能危及人類和家養(yǎng)動(dòng)物健康和安全，或危及財(cái)產(chǎn)。

What is the safetyobjective of low voltage directive?

Electrical e does notendanger the health and safety of persons and domestic animals, orproperty, when properly installed and maintained and used inapplications for which it was made.

Q4.如何識(shí)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(hào)、批次或序列號(hào)或其他可以識(shí)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(cè)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(diǎn)；

3）進(jìn)口商應(yīng)在產(chǎn)品上顯示進(jìn)口商的名稱、注冊(cè)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 toidentify the product, manufacturer andimporter?

1) Manufacturers shall ensureproduct bears a type, batch or serial number or other element foridentification or not possible, on the packaging or accompanyingdocument ;

2) Manufacturers shall indicatemanufacturer’s name, registered trade name or trade mark and postaladdress on the product, or not possible, on the packaging oraccompanying document. The address shall indicate a singlepoint;

3) Importer shall indicateimporter’s name, registered trade name or trade mark and postaladdress on the product, or not possible, on the packaging oraccompanying document.

Q5.如何符合低電壓指令？

通過(guò)制造商的符合性評(píng)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(xiǎn)分析和評(píng)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(shí)。

How to comply with thelow voltage directive?

By conformity assessmentprocedure: Internal production control (mode A) bymanufacturers

1) Technical documentation whichincludes an adequate analysis and assessment of therisk(s);

2) Manufacturing process and itsmonitoring shall ensure compliance of the manufactured product withthe technical documentation;

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

4) Affixing of CEmarking.

Q6.“技術(shù)文件”應(yīng)包括哪些內(nèi)容？

1）充分的風(fēng)險(xiǎn)分析和評(píng)估；

2）電氣產(chǎn)品的總體描述；

3）設(shè)計(jì)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(duì)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，或國(guó)家標(biāo)準(zhǔn)的清單，以及在沒(méi)有使用協(xié)調(diào)標(biāo)準(zhǔn)或或國(guó)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)或或國(guó)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(jì)計(jì)算和檢驗(yàn)的結(jié)果等；

7）檢測(cè)報(bào)告。

What shall beincluded in “Technical documentation”?

1) An adequate analysis andassessment of the risk(s);

2) A general description of theelectrical e;

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

4) Descriptions and explanationsnecessary for the understanding of those drawings and schemes andthe operation of the electrical e;

5) A list of the harmonisedstandards applied in fl or in part or international or nationalstandards and, where those harmonised standards or international ornational standards have not been applied, descriptions of thesolutions adopted to meet the safety objectives of this Directive,including a list of other relevant technical specificationsapplied. In the event of partly applied harmonised standards orinternational or national standards, the technical documentationshall specify the parts which have been applied;

6) Rests of design calcationsmade, examinations carried out, etc.;

7) Test reports.

Q7.“風(fēng)險(xiǎn)分析和評(píng)估”怎么做？

1）制造商應(yīng)負(fù)責(zé)建立正確的風(fēng)險(xiǎn)評(píng)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(duì)風(fēng)險(xiǎn)管理的風(fēng)險(xiǎn)評(píng)估技術(shù)或其他適用的方法；ISO/TR14121-2指導(dǎo)制造商在風(fēng)險(xiǎn)分析和評(píng)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(duì)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(chǎng)監(jiān)管機(jī)構(gòu)提供風(fēng)險(xiǎn)評(píng)估的資料，將會(huì)導(dǎo)致相應(yīng)的處罰。

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

1) Manufacturer is responsiblethat the risk assessment (test procedure and document) isestablished in the right way;

2) Manufacturer may refer to therisk assessmentues for risk management described in EN31010:2010 (IEC/ISO 31010:2009) or other applicable method; ISO/TR14121-2 guides the manufacturer may use the team approach for riskanalysis and assessment;

3) Manufacturer shall havedocumented evidence that Annex I (principal elements of the safetyobjectives) is ffilled;

4) If manufacturer can’t providea risk assessment to the market authorities, penalties arepossible.