2014年3月29日,歐盟在官方公告上發布多項新的指令,以替換原有新方法指令。本次發布的新指令并無技術內容的修改。新指令要求各成員國應在2016年4月19日之前將指令轉化為本國法令,并自公告之日起第20天(即2014年4月20日)開始生效。2014 29th Mar. EU announced new directives to replace the originalones. There is no technical content changes. each member were required to convert the new directivesinto national ones before2016 19th and began to take effect 20 days from the date of announcement.
1、2014/28/EU
指令名稱Directivetitle:民用易爆物品 Civilexplosives
替代指令OriginalDirective:93/15/EEC、2004/57/EC(兩者因范圍重疊進行合并Both for range overlap merging )
2、2014/29/EU
指令名稱Directivetitle :簡單壓力容器Simple pressure vessels
替代指令OriginalDirective:2009/105/EC
3、2014/30/EU
指令名稱Directivetitle :電磁兼容 EMC
替代指令OriginalDirective:2004/108/EC
4、2014/31/EU
指令名稱Directivetitle:非自動衡器The automatic weighing apparatus
替代指令OriginalDirective :2009/23/EC
5、2014/32/EU
指令名稱Directivetitle :測量儀器Measuringinstrument
替代指令OriginalDirective :2004/22/EC
6、2014/33/EU
指令名稱Directivetitle :電梯和電梯安全部件Theelevator and elevator safety components
替代指令OriginalDirective :95/16/EC
7、2014/34/EU
指令名稱Directivetitle :用于潛在爆炸性環境中的設備和防護系統Of equipment and protective systemsfor potentially explosive environment
替代指令OriginalDirective :94/9/EC
8、2014/35/EU
指令名稱Directivetitle :低電壓設備Lowvoltage equipment
替代指令OriginalDirective :2006/95/EC
2014年5月22日,無線電設備指令(TheRadio Equipment Directive,RED)2014/53/EU正式在歐盟官方公報(OG)上公布,并于2014年6月12日生效。該指令將取代無線電與電信終端設備指令(R&TTE指令),2016年6月12日之前,成員國應將該指令轉化為成員國法律,原R&TTE指令(1999/5/EC)也隨之作廢。2016年6月13日起,成員國應采用新無線電設備指令(RED);2017年6月13日起,符合舊R&TTE指令的產品將不允許在歐盟市場上銷售。 On May 22, 2014, RED2014/53/EU Officially published in theEuropean Union's official gazette , and take effect on June 12, 2014. Thedirective will replace R&TTE directive, Before June 12, 2016, member statesshould convert the directive to member states law and the original R&TTEdirective (1999/5 / EC) is invalid. June 13, 2016, member states should adoptthe new RED; from June 13, 2017 products that meet the old R&TTE directivewill not be allowed in the eu market.
1、2014/53/EU
指令名稱Directivetitle :無線電設備指令(REDdirective)
替代指令OriginalDirective :1999/5/EC(R&TTEdirective)
2014/30/EU更新與舊版2004/108/EC的區別difference between 2014/30/EU and 2004/108/EC
更新的EMC指令將于2014年4月18日生效。舊有的EMC指令2004/108/EC將于
2016年4月20日廢除. The updated EMC directive willtake effect on April 18, 2014. The old EMC directive will be abolished on April20, 2016.
1、新指令亦于技術文文件中,加入新要求 : Newinstructions in technical documents, add new requirements:
設計概念和制造圖像,以及組件方案、子組件、原理等Design concept and manufacturingimage, as well as the component scheme, child components, principle, etc
必要的描述和說明,以理解那些圖像和方案,以及理解該設備操作Description and instructionsnecessary to understand those images and scheme, and understand the equipmentoperation
官方形式的不符合狀況也列明在新指令中。新指令指出,任何會員國 應要求相關經濟營運者糾正不符合狀況,或有關會員國應采取一切適當措施以限制或禁止已于市場上提供的設備,或確保其設備于市場中被召回或撤走Not complywith the conditions of the official form is listed in the new instructions. Newinstructions, points out that any member states shall require the relevanteconomic operators correct that does not comply with theconditions, or the relevant member states shall take all appropriate measuresto restrict or ban what has been on the market to provide equipment, to ensure the equipment in the market have beenrecalled or withdrawal
制造商應加貼CE標志于每一件個體設備上,以滿足本指令的合適要求。而制造商亦應為設備模型,制定書面歐盟合規聲明。當設備已投放市場,該聲明應與技術文檔保存一起。直至10年后,再可透過國家級機構進行處置Manufacturers should label with theCE mark on each individual device, in order to meet the appropriaterequirements of this directive . And manufacturers should be equipment models,writing the EU compliance statement . When a device has been put on the market,the statement should be kept with the technical documents together. Until 10years later, it can be disposal through the national agency.
l新指令涵蓋的產品包括新型投放于歐盟市場的產品,以及以不同形式供應的產品,包括遠程銷售類產品。但它并不適用于只能單獨用于研究及開發設施等用途的特制評估套件New instructions covering productsincluding new products into the EU market, and the supply of products invarious forms, including remote sales products. But it does not apply to whichcan only be used separately for the purposes of research and developmentfacilities such as special assessment suite
l分銷商須于本指令(2014/30/EU)完全取代舊有指令(2004/108/EC)前,作出合理過渡性安排,將訂單產品(即已提供到分銷鏈上的庫存設備)投放于市Distributor shall in this directive(2014/30 / EU) completely replace the old directive (2004/108 / EC), makereasonable transitional arrangements, will order the product (i.e., theinventory of equipment) has provided to the distribution chain in the market
l新指令清晰地陳述各種經營者,即生產商、授權代表、分銷商、進口商及其有關產品之各自代表,在供應和銷售鏈上的義務和責任New directives clearly statedvarious obligations and responsibilities in the supply and distribution chainof operators, manufacturers, authorized representative, distributors, importersand related products suppliers
l新指令制訂了合格評定機構(Conformity Assessment Bodies) 通告的詳細規定。當中詳細指出受通告機構的所有要求和義務。還詳細指出公告機構(Notified Bodies) 的所有要求、義務、申請、變更、運作、上訴和相互協調New instructions formulate the detailed rules of conformityassessment agency announcement. Itpoints out all the requirements and obligations for notified institutions. Alsopoints out all the requirements and obligations, application, alteration,operation, appeal, and coordinate with each other for the Notified bodies indetails.
新RED指令規定了放置無線電設備的統一規則,包括市場上的蜂窩電話、汽車開門裝置和調制解調器。新指令旨跟上數量和種類都不斷增長的無線電設備和裝置的步伐,并確保它們相互之間或對人類健康不會造成干擾。新RED指令的主要內容如下:
New RED directive placed the unity of theradio equipment code, including the cellular phone on the market, car dooropener, and modem. New directives tokeep up with the increasing pace of number and variety of the radio equipmentand devices, and ensure that they are to each other or not cause interferenceto human health. The main content of the new RED instructions are as follows:
1、新立法框架(NLF)對于所有CE標志新方法指令,新立法框(NLF)的
一致性問題將是共同的,具體包括:The(NLF) cause sexual problems will be common. Both for all CE marking directiveand (NLF).
制造商、授權代表、進口商和分銷商的新責任Manufacturers, authorizedrepresentatives, importers and distributors of new responsibilities
制造商出具的強制的單一的符合性聲明(DoC)Issued by the manufacturer of thecompulsory single conformance statement (DOC)
技術結構文件(TCF)的要求The requirements of technicalstructure file (TCF)
根據要求對技術結構文件(TCF)進行翻譯According to the requirements oftechnical structure file (TCF) for translation
保障條款和正式的非合規性The compliance of safeguards andformal
常見的DOC模板Common DOC template
2.該指令提案還包括部分技術變化,詳細包括: theinstruction proposal also includes some technical changes, including:
涵蓋范圍的變化The change of scope
無線電設備的定義The definition of the radioequipment
對于軟件定義(software-defined)的無線電的規定For the regulation of softwaredefined radio
無線電設備的新注冊制度The new registration system of theradio equipment
用戶手冊中的額外信息Additional information in the usermanual
允許的簡化版DoCAllowa slimmed-down version of the DoC
包裝上的地理信息The geographic information on thepackage
僅在沒有協調標準的情況下,才需要公告機構(NB)Only in the absence of coordinationstandard, only need to be notified body (NB)
只在質量保證模式下需要NBIDOnly need NBID in quality assurancemodel
投放市場時無需通告成員國On the market without notice memberstates
正式要求加貼警示標志Formal request labeled with warningsigns
CE標志不再需要在產品說明書中,僅需加貼在產品和包裝上CE mark is no longer needed in theproduct manual, only those who on the products and packaging
l對于安全/EMC方面的評估,制造商有以下選擇:OEM聲明、NB參與+該類型的OEM證書、或NB進行的完全質量保證模式For safety/EMC assessment,manufacturers have the following options: OEM statement and NB to participatein this type of OEM certificate, or completely quality guarantee for the NBmodel
l對于完全使用協調標準的無線電方面的評估,制造商有相同的3項選擇,如果沒有完全使用協調標準,OEM聲明是不允許的For fully using coordinateassessment standard on radio, manufacturers have the same three options. OEMstatement is not allowed if not fully using coordinate standard.