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   新版LVD低電壓指令介紹: 2014/35/EU

  為適應歐盟新立法框架(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入以及對消費者生命財產更高水平的保護:

  1 明確了制造商,進口商和分銷商的責任;

  2 在符合性證明中電子手段的更廣泛應用;

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

  4 更加完善的市場監督機構追蹤及阻止危險產品的進口;

  Q1低電壓指令的范圍是什么?

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

  a. 在爆炸環境中使用的電氣產品

  b. 在輻射或醫療用途中使用的電氣產品

  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制定的安全規定,使用在船舶,飛機或鐵路中的專用電氣產品

  i. 專業人員使用的,僅用于研發場所的作為研發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條中的對經濟運營商的義務的新增要求,源自768/2008/EC 附錄I的 R2~R7;

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

  4)更具體的關于市場監管的要求,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 “專業人員使用的,僅用于研發場所的作為研發用途的定制的評估裝備”;

  6)附錄III中準備技術文件的額外要求 “對風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?

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

  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.如何識別產品,制造商和進口商?

  1)制造商應確保產品上標有型號、批次或序列號或其他可以識別的要素,或者如果不可能,應標在包裝或隨附文件上;

  2)制造商應在產品上顯示制造商的名稱、注冊的商標名稱或商標標志和郵政地址,或者如果不可能,應標在包裝或隨附文件上。地址應當是單一地點;

  3)進口商應在產品上顯示進口商的名稱、注冊的商標名稱或商標標志和郵政地址,或者如果不可能,應標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:內部生產控制(模式A)

  1)準備包括充分風險分析和評估的技術文件;

  2)制造流程和它的監督應確保所制造的產品符合技術文件的規定;

  3)起草歐盟符合性聲明(DoC);

  4)張貼CE標識。

  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.“技術文件”應包括哪些內容?

  1)充分的風險分析和評估;

  2)電氣產品的總體描述;

  3)設計理念和制造圖紙,以及零部件、組裝件的明細等;

  4)為理解對應的圖紙和明細以及電氣產品的工作所需的必要的描述和解釋;

  5)全部或部分應用的協調標準,或國際標準,或國家標準的清單,以及在沒有使用協調標準或國際標準或國家標準的情況下,為符合指令的安全目標所采用的解決方案的描述,包括所應用的其他相關技術規范的清單。如果部分應用了協調標準或國際標準或國家標準,技術文件中應指明所應用的部分;

  6)所作的設計計算和檢驗的結果等;

  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.“風險分析和評估”怎么做?

  1)制造商應負責建立正確的風險評估(程序和文件);

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

  3)制造商應保存文件化的證據顯示對附錄I(安全目標的要素)的符合性;

  4)如果制造商不能向市場監管機構提供風險評估的資料,將會導致相應的處罰。

  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.

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