中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2014年
11期
35-37
,共3页
医疗器械%RoHS符合性
醫療器械%RoHS符閤性
의료기계%RoHS부합성
medical device%RoHS%compliance
随着RoHS指令修订,RoHS 2.0被纳入为有源医疗器械产品CE认证必须符合的指令之一。2014年7月22日,M D D指令(93/42/E E C)中的有源医疗器械产品投放欧盟市场必须符合RoHS 2.0要求。2016年7月22日,IVD指令(98/79/EC)的有源医疗器械产品投放欧盟市场必须符合RoHS 2.0要求。一旦违规,企业将可能受到欧盟的处罚及造成重大损失,甚至禁止企业产品的出口,这在电子产品业界已早有先例。RoHS 2.0指令要求医疗器械企业必须建立内部过程管理控制,供应链及物料符合性评价,产品符合性验证及制作技术文档等工作,来确保医疗器械产品持续符合RoHS 的要求。SGS凭借多年专业技术及服务经验,能为医疗器械企业满足RoHS 2.0提供系统和有效措施以确保产品的合规性,帮助医疗器械企业更快进入目标市场创造更大的价值。
隨著RoHS指令脩訂,RoHS 2.0被納入為有源醫療器械產品CE認證必鬚符閤的指令之一。2014年7月22日,M D D指令(93/42/E E C)中的有源醫療器械產品投放歐盟市場必鬚符閤RoHS 2.0要求。2016年7月22日,IVD指令(98/79/EC)的有源醫療器械產品投放歐盟市場必鬚符閤RoHS 2.0要求。一旦違規,企業將可能受到歐盟的處罰及造成重大損失,甚至禁止企業產品的齣口,這在電子產品業界已早有先例。RoHS 2.0指令要求醫療器械企業必鬚建立內部過程管理控製,供應鏈及物料符閤性評價,產品符閤性驗證及製作技術文檔等工作,來確保醫療器械產品持續符閤RoHS 的要求。SGS憑藉多年專業技術及服務經驗,能為醫療器械企業滿足RoHS 2.0提供繫統和有效措施以確保產品的閤規性,幫助醫療器械企業更快進入目標市場創造更大的價值。
수착RoHS지령수정,RoHS 2.0피납입위유원의료기계산품CE인증필수부합적지령지일。2014년7월22일,M D D지령(93/42/E E C)중적유원의료기계산품투방구맹시장필수부합RoHS 2.0요구。2016년7월22일,IVD지령(98/79/EC)적유원의료기계산품투방구맹시장필수부합RoHS 2.0요구。일단위규,기업장가능수도구맹적처벌급조성중대손실,심지금지기업산품적출구,저재전자산품업계이조유선례。RoHS 2.0지령요구의료기계기업필수건립내부과정관리공제,공응련급물료부합성평개,산품부합성험증급제작기술문당등공작,래학보의료기계산품지속부합RoHS 적요구。SGS빙차다년전업기술급복무경험,능위의료기계기업만족RoHS 2.0제공계통화유효조시이학보산품적합규성,방조의료기계기업경쾌진입목표시장창조경대적개치。
With the RoHS directive recast, RoHS 2.0 become one of directives that active medical device should compliance with when apply for CE certiifcation. Active medical device in the scope of Medical device directive (93/42/EEC) placing on the market must compliance with RoHS 2.0 directive requirement after July 22, 2014. And Active medical device in the scope of in vitro diagnostic medical devices (98/79/EC) placing on the market should meet the requirements of RoHS 2.0 after July 22, 2016. Manufacturer wil be disciplined by the European Union and caused signiifcant losses if not conform to RoHS, even more serious, products would prohibit of export. Event like that have been happen in electrical and electronic industry. Establish internal control process, assess compliance of materials in supplier chain, verify RoHS product conformity for RoHS and prepare technical documentation are the base requirements of RoHS. Active medical device manufacturer should meet those requirements to assure their products continue compliance with RoHS. With professional skil and many years of experience, SGS can provide systematic and effective measures to assure the conformity of RoHS. In addition, we also can help medical device manufacture enter the target market, improve the efifciency of management, and create greater value.