CE認(rèn)證模的9種基本模式以及各類醫(yī)療器械認(rèn)證流程圖

?可修編.?可修編.CE隊址的9種基本模式對干幾乎所有的歐盟產(chǎn)品荷令來說，岳令通常會給站造商提供出幾種CE從證的模式（Module）,Uig商可根襦本身的劇量體裁衣，選擇最適臺自已的模武。一般阻說，CE汰證模式可分為以下9種基本模式:*ModuleA:internalproductioncontrol模式A:內(nèi)部生產(chǎn)腔制（自我聲明）*ModuleAa:interventionofaNotifiedBody模式Aa:內(nèi)部生產(chǎn)腔制M第3方槍測*ModuleB:ECtype-examination模式B:EC塑式試驗*ModuleC:conformitytotype模式C:符合型式*ModuleD:productionqualityassurance模式D:生產(chǎn)質(zhì)量保證*ModuleE:productqualityassurance模靈E:產(chǎn)品I貫量區(qū)證*ModuleF:productverification模式F:產(chǎn)品驗j**ModuleG:unitverification模式G:單元驗證*ModuleH:fullqualityassurance模式H:全面質(zhì)量保證基于以上幾種基本模式的不同組合，艮可能何生出其它若干種不同的模式。一般地說，并非任何一種模式溝可適用于所有的產(chǎn)品。旗言之，也并非制ifi商可選取以上任何一種模式來對其產(chǎn)品逍行CEUiio-類醫(yī)療器植CE從卅湮算圖（巾英文對照）I類醫(yī)療彖械的&認(rèn)證流程圖CLASSIMEDICALDEVICES?CEMARKINGROUTESCLASSIMEDICALDEVICES?CEMARKINGROUTES\wvw.CE?vwwCE-markingnetwww.CE-www.CE-v<ww.CE-marking.dewww.CE-mafking.co.uk?版儀所有英湯佯凜wwwCE-marking.euwww.CE-vmwCE-mari<ing.etJwww.CE?marking.usHa類醫(yī)療??CEUiiX程圖（中英文對照）CLASSIlaMEDICALDEVICES?CEMARKINGROUTESIla類醫(yī)療聚械的認(rèn)證流程圖lib類醫(yī)療卷橫CEUii澹程圖（中英文對照）CLASSIIBMEDICALDEVICES?CEMARKINGROUTESlib類醫(yī)療器械的C&人證流程圖川類醫(yī)療（中英文對照）CLASSIIIMEDICALDEVICES?CE/AARKINGROUTESIII類醫(yī)療器械的C€認(rèn)證澆程圖IVD體外歡斷醫(yī)療器itCEik證灣程圖FlowchanfortheconformityassessmentprocodurosprovidedforinDiroclivo98/79/EConinvitrodiagnosticmedicaldovicosIntonoodforrperfonnanceIevdwtionEC(teuaralxxicfconfurrnt://Proc<xliroacc±aMiupbythemanifactLrerbJIFHtn?IUcvicgco*/e<ed( toin]RegistrationwithCA-CompetentAuthorityMUUIJLLaWOIX1Fbeaoa2r3tionaconncmitf*Bxaniifwoznof站?護(hù)MnsII)JIOOULLD，V^nu-rac&iiMsbzturer5:皿jznedtorrA.IKIU)marenredi^nwxIV)CCdeclarationofconformity/proeixtionqEdyawiJarK："vsrfc3toncCmsrufac(uroflprodjzts0mc*7111Regis

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