CE认证模的9种基本模式以及各类医疗器械认证流程图

•可修編.•可修編.CE队址的9种基本模式对干几乎所有的欧盟产品荷令来说，岳令通常会给站造商提供出几种CE从证的模式（Module）,Uig商可根襦本身的劇量体裁衣，选择最适台自已的模武。一般阻说，CE汰证模式可分为以下9种基本模式:*ModuleA:internalproductioncontrol模式A:内部生产腔制（自我声明）*ModuleAa:interventionofaNotifiedBody模式Aa:内部生产腔制M第3方枪測*ModuleB:ECtype-examination模式B:EC塑式试验*ModuleC:conformitytotype模式C:符合型式*ModuleD:productionqualityassurance模式D:生产质量保证*ModuleE:productqualityassurance模灵E:产品I贯量区证*ModuleF:productverification模式F:产品验j**ModuleG:unitverification模式G:单元验证*ModuleH:fullqualityassurance模式H:全面质量保证基于以上几种基本模式的不同组合，艮可能何生出其它若干种不同的模式。一般地说，并非任何一种模式沟可适用于所有的产品。旗言之，也并非制ifi商可选取以上任何一种模式来对其产品逍行CEUiio-类医疗器植CE从卅湮算图（巾英文对照）I类医疗彖械的&认证流程图CLASSIMEDICALDEVICES・CEMARKINGROUTESCLASSIMEDICALDEVICES・CEMARKINGROUTES\wvw.CE・vwwCE-markingnetwww.CE-www.CE-v<ww.CE-marking.dewww.CE-mafking.co.uk©版仪所有英汤佯凜wwwCE-marking.euwww.CE-vmwCE-mari<ing.etJwww.CE・marking.usHa类医疗»«CEUiiX程图（中英文对照）CLASSIlaMEDICALDEVICES・CEMARKINGROUTESIla类医疗聚械的认证流程图lib类医疗卷横CEUii澹程图（中英文对照）CLASSIIBMEDICALDEVICES・CEMARKINGROUTESlib类医疗器械的C&人证流程图川类医疗（中英文对照）CLASSIIIMEDICALDEVICES・CE/AARKINGROUTESIII类医疗器械的C€认证浇程图IVD体外欢斷医疗器itCEik证湾程图FlowchanfortheconformityassessmentprocodurosprovidedforinDiroclivo98/79/EConinvitrodiagnosticmedicaldovicosIntonoodforrperfonnanceIevdwtionEC(teuaralxxicfconfurrnt://Proc<xliroacc±aMiupbythemanifactLrerbJIFHtn•IUcvicgco*/e<ed( toin]RegistrationwithCA-CompetentAuthorityMUUIJLLaWOIX1Fbeaoa2r3tionaconncmitf*Bxaniifwoznof站・护MnsII)JIOOULLD，V^nu-rac&iiMsbzturer5:皿jznedtorrA.IKIU)marenredi^nwxIV)CCdeclarationofconformity/proeixtionqEdyawiJarK："vsrfc3toncCmsrufac(uroflprodjzts0mc*7111Regis

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