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1、EUROPEANSTANDARDNORMEEUROPEENNEEuropAischeENISO13485March2016NORMICS03.120.10;11.040.01SupersedesENISO13485:2012EnglishversionMedicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2016)Dispositifsmcdicaux-SystcmesdemanagcmcnidelaMcdizinproduktc-Qualitatsmanagcmcntsystcmc
2、-qualitd-ExigencesAdesfinsrcglcmcntaircs(ISOAnlbrdcrungcnfiirFCgUIaloriSChCZwcckc(ISO13485:2016)13485:2016)ThisEuropeanStandardwasapprovedbyCENon30January2016.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofa
3、nationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexistsinthreeofcialversions(English,French,German).Aversioninanyotherlanguagemadebyt
4、ranslationundertheresponsibilityofaCENandCENELECmemberintoitsownlanguageandnotifiedtoheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Belgium.Bulgaria.Croatia,Cyprus,CzechRepublic.Denmar
5、k.Estonia,Finland,FonnerYugoslavRepublicofMacedonia.France.Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.CENELECCEN-CENELECManagementCentre:AvenueMarnix17,B-1
6、00OBrussels2016CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembersandforCENELECMembers.Ref.No.ENISO13485:2016EEuropeanforewordThisdocument(ENISO13485:2016)hasbeenpreparedbyTechnicalCommitteeISO/TC210Qualitymanagementandcorrespondinggeneralaspectsformedicald
7、evicesincollaborationwithTechnicalCommitteeCEN/CLC/TC3QualitymanagementandcorrespondinggeneralaspectsformedicaldevicesthesecretarialofwhichisheldbyNEN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbySeptember2016,andconfli
8、ctingnationalstandardsshallbewithdrawnatthelatestbyMarch2019.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENand/orCENELECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO13485:2012.Thisdocumenthasbeenprepa
9、redunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirectives.ForrelationshipwithEUDirectives,seeinformativeAnnexZA,ZBandZC,whichareintegralpartsofthisdocument.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorgani
10、zationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria.Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,LatVia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland.Portug
11、al,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandtheUnitedKingdom.Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.Fordatedreferences,onlytheeditioncitedapplies.How
12、ever,foranyuseofthisstandardwithinthemeaningofAnnexZA,ZBandZC,theusershouldalwayscheckthatanyreferenceddocumenthasnotbeensupersededandthatitsrelevantcontentscanstillbeconsideredthegenerallyacknowledgedstate-of-art.WhenanIECorISOstandardisreferredtointheISOstandardtext,thisshallbeunderstoodasanormati
13、vereferencetothecorrespondingENstandard,ifavailable,andotherwisetothedatedversionoftheISOorIECstandard,aslistedbelow.NOTEThewayinwhichthesereferenceddocumentsarecitedinnormativerequirementsdeterminestheextent(inwholeorinpart)towhichtheyapply.Table1CorrelationbetweennormativereferencesanddatedENandIS
14、OstandardsNormativereferencesaslistedinClause2oftheISOstandardEquivalentCkENItedstandardISOISO9000:2015ENISO9000:2015ISO9000:2015EndorsementnoticeThetextofISO13485:2016hasbeenapprovedbyCENasENISO13485:2016withoutanymodification.AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssenti
15、alRequirementsofEUDirective90/385/EEC(asamended)ZA.OGeneralThisEuropeanstandardhasbeenpreparedunderaCommissionsstandardisationrequestM/023toprovideonevoluntarymeansofconformingtorequirementsofCouncilDirectiveof20June1990ontheapproximationofthelawsoftheMemberStatesrelatingtoactiveimplantablemedicalde
16、vicesOJL189.OnccthisEuropeanStandardiscitedintheOfficialJournaloftheEuropeanUnionunderDirective90/385/EEC(asamended)andhasbeenimplementedasanationalstandardinatleastoneMemberState,compliancewiththenormativeclausesofthisEuropeanStandardgiveninTableZA.1orTableZA.2confer,withinthelimitsofthescopeofthis
17、EuropeanStandard,apresumptionofconformitywiththerequirementsonamanufacturersqualitysystemasgiveninAnnexes2and5ofthatDirectiveandassociatedEFTAregulations.ThisAnnexZAexplainstowhichrequirements,underwhichconditionsandtowhatextentpresumptionofconformitycanbeclaimed.ENISO13485:2016providesrequirementsf
18、oraqualitysystemapplicabletomedicaldevices.Becausethisstandarddescribesaqualitysystemthatisconnectedinpartorinwholetotheconformityassessmentrequirementsof90/385/EEC(asamended),itisnotmeaningfultolinkindividualclausesofthestandardtospecificEssentialRequirements.CompliancewithallthenormativeclausesinE
19、NISO13485willensurethataprocessisinplacetoaddressqualitysystemaspectsrelatedtomedicaldevices,whichareincludedintheconformityassessmentannexesoftheDirective.However,becausethisisanadoptionofaninternationalstandard,intendedtobeapplicableinjurisdictionsallovertheworld,itisnottheprimarygoalofthestandard
20、tocoverexactlytheEuropeanqualitysystemrequirements.Therefore,forallofthequalitysystemrequirements,conformityisnotentirelyachievedbycomplyingonlywiththerequirementsspecifiedinthisstandard.ManufacturersandconformityassessmentbodieswillneedtofeedthequalitysystemrequirementsintheapplicableAnnexoftheDire
21、ctiveintotheprocessesprovidedbythestandard.ExplanationonthecorrespondenceofthestandardandtherequirementsoftheDirectiveisincludedinTablesZA.1andZA.2.TheConformityAssessmentAnnexes2and5oftheDirectiveincludedescriptionoftheregulatoryprocessandactivitiesundertakenbytheNotifiedBody,whichbothareoutsideoft
22、hescopeofthisEuropeanStandardandthereforenotcoveredbythisEuropeanStandard.Furthermore,therequirementsoftheDirectiverefertoanapplicationtoaNotifiedBody,nottotherequirementforaqualitysystemassuch.Accordingly,coverageoflegalrequirementscanonlybepresumedtotheextentlistedinTablesZA.1andZA.2inanapplicatio
23、ntoaNotifiedBody: containsthenecessaryqualitysystemdocumentation; hasbeenreviewedandapprovedbyaNotifiedBody,andtheundertakingslistedintheapplicationarecorrectlyexecutedbythemanufacturer.NOTE1WhereareferencefromaclauseofthisEuropeanStandardtotheriskmanagementprocessismade,theriskmanagementprocessneed
24、stobeincompliancewithDirective98/79/EC,asamendedby2007/47/EC.Thismeansthatriskshavetobereduced*asfaraspossible*,toaminimum,tothelowestpossiblelevel*,minimizedorremoved,accordingtothewordingofthecorrespondingessentialrequirement.NOTE2Themanufacturerspolicyfordeterminingacceptableriskmustbeincomplianc
25、ewithessentialrequirements1,4,5,8,9and10oftheDirective.SeeENISO14971,AnnexZBfortheinterpretationofthisexpressioninthelightoftheEUDirective.NOTE3ThisAnnexZAisbasedonnormativereferencesaccordingtothetableofreferencesintheEuropeanforeword,replacingthereferencesinthecoretext.NOTE4Whenarequirementdoesnot
26、appearinTableZA.1orZA.2,itmeansthatitisnotaddressedbythisEuropeanStandard.NOTE5ThisannexusesthetermMqualitysystemHasusedintheDirectivewhereasthisEuropeanStandardusesthetermqualitymanagementsysteminaccordancewithISOterminology.ZA.1RelationshipwithAnnex2ofDirective90/385/EEC(asamended)Compliancewithth
27、isEuropeanStandarddoesnotprovidepresumptionofconformitywithalltheaspectsofAnnex2,asoutlinedinTableZA.I.Therefore,amanufactureroraNotifiedBodyhastotakeadditionalprovisionstoensureconformity,andclaimorcertifyconformance,withAnnex2ofthisDirective.Thelegalrequirementsmustbeexamined,appliedandverifiedone
28、byoneandthesolutionsadoptedmustbecomepartofthequalitysysteminthemeaningoftheDirective.TableZA.1CorrespondencebetweenthisEuropeanStandardandAnnex2ofDirective90/385/EEC(asamended)ParagraphofDirective90/385/EEC,Annex2Clause(s)ofthisEuropeanStandardConimentsZQualifyingremarks3.1,1stsentenceNotcovered.3.
29、1,2ndsentence,1stindentNotcovered.3.1,2ndsentence,2ndindent4.1.1,4.1.2,4.1.3,4.1.4,4.1.6,4.2.1,4.2.2,423,4.2.4,4.2.5Covered.ThedocumentationrequiredinthisEuropeanStandardcoversthequalitysystemdocumentationmeantin3.2ofAnnex2whentheexplicitlegalrequirementsareincorporatedintothequalitysystemdocumentat
30、ion.Seealsocoverageof3.2below.3.1,2ndsentence,3rdindent4.1,5.1,5.4,5.5,5.6Coveredinpart.ThisEuropeanStandardrequirestopmanagementcommitmenttoimplementationofthequalitysystemandthatdocumentedproceduresareimplementedbutdoesnotrequireasignedundertaking.3.1,2ndsentence,4thindent4.1,5.1,5.4,5.5,5.6Covere
31、dinpart.ThisEuropeanStandardrequiresmaintenanceoftheapprovedqualitysystembutdoesnotrequireasignedundertaking.3.1,2ndsentence.5thindentNotcovered.ThisEuropeanStandardincludesrequirementsonpost-marketsurveillance,andreportingadverseeventsandfieldsafetycorrectiveactionstoauthoritiesbutdoesnotcoverallth
32、edetailsrequiredbytheDirectiveincludingtimescalesforreporting.3.2,1stparagraphNotcovered.TheapplicationofthisEuropeanStandarddoesnotbyitselfensurethefulfilmentofallregulatorrequirementsoftheDirective.Thelegalrequirementsmustbeexamined,appliedandverifiedonebyoneandthesolutionsadoptedbecomepartofthequ
33、alitysysteminthemeaningoftheDirective.ParagraphofDirective90/385/EEC,Annex2Clause(s)ofthisEuropeanStandardCommentS/Qualifyingremarks3.2,2ndparagraph,1stsentence4.L4.2Covered.3.2,2ndparagraph,2ndsentence4.1A2Covered.3.2,2ndparagraph,3rdsentence4.L4.2,7Coveredprovidedqualitymanagementsystemdocumentati
34、onmakespossibleauniforminterpretationofthequalitypoliciesandProCedUres,suchasqualityprograms,qualityplans,qualitymanualsandqualityrecords,andthattheapplicabledocumentationlistedin3.2ofAnnex2isincorporatedintothequalitysystemdocumentation.3.2,3rdparagraph(a)421,4.2.3,5.1.5.3,5.4.1Covered.3.2,3rdparag
35、raph(b)4.2.2,5.1.1Covered.3.2,3rdparagraph(b),1stindent4.2.2,5.1,5.5.1,5.5.2Covered.3.2,3rdparagraph(b),2ndindent4.1,5.6,7.1,8.2.4,8.3,8.4,8.5.2,8.5.3CoveredprovidedthatthemethodsandacceptancecriteriachosenbythemanufacturerensurethattherequirementsoftheDirectivearefulfilled.3.23rdparagraph(b)3rdinde
36、nt1,4.1,4.2,7.4,8.5.1Covered.3.23rdparagraph(c)1stindent4.2,7.3.2,7.3.3,7.3.7,7.3.9,7.3.10Coveredprovidedthattheapplicablequalitymanagementsystemdocumentationincludesdesignspecificationsidentifyingstandardswhichwillbeappliedandadescriptionofthesolutionsadoptedtofulfiltheessentialrequirementswhichapp
37、lywhenharmonizedstandardsarenotappliedinfull.3.2,3rdparagraph(c),2ndindent7.3.1,7.3.6,7.3.7,7.3.9Covered.3.2,3rdparagraph(c),3rdindentNotcovered.3.2,3rdparagraph(c),4thindent7.3.6,7.3.7Coveredprovidedthatthequalitymanagementsystemrecordsincludethepre-clinicalevaluation.3.2,3rdparagraph(c),5thindentN
38、otcovered.Clause7.3.7docsnotincludethedetailsofAnnex7.3.2,3rdparagraph(d),1stindent4.2,6.4,7.1,7.47.5Coveredprovidedthatthequalitymanagementsystemdocumentationincludesrelevantdocumentsandrecordsinregardstosterilizationandpurchasing.3.2,3rdparagraph(d),2ndindent4.2,7.5.8,7.5.9Covered.3.2,3rdparagraph
39、(e)4.2,7.1,7.4.3,7.5.1,7.5.9.1,7.6,8.2.6Coveredprovidedthatthedocumentedfrequencyatwhichtestsarecarriedoutisdetailedinthequalitymanagementsystemdocumentation.6.1Notcovered.ThespecifictimeperiodsinDirectivearenotspecifiedin4.2.4or4.2.5.ZA.2RelationshipwithAnnex5ofDirective90/385/EEC(asamended)Complia
40、ncewiththisEuropeanStandarddoesnotprovidepresumptionofconformitywithalltheaspectsofAnnex5,asoutlinedinTableZA.2.Therefore,amanufactureroraNotifiedBodyhastotakeadditionalprovisionstoensureconformity,andclaimorcertifyconformance,withAnnex5ofthisDirective.Thelegalrequirementsmustbeexamined,appliedandve
41、rifiedonebyoneandthesolutionsadoptedmustbecomepartofthequalitysysteminthemeaningofthedirective.TableZA.2CorrespondencebetweenthisEuropeanStandardandAnnex5ofDirective90/385/EEC(asamended)ParagraphofDirective90/385/EEC,Annex5CIause(三)ofthisEuropeanStandardCOmmCntS/Qualifyingremarks3.1,1stparagraphNotc
42、overed.3.1,2ndparagraph,1stindentNotcovered.3.1,2ndparagraph,2ndindent4.1.1,4.1.2,4.1.3,4.1.4,4.1.6,4.2.1,4.2.2,4.2.3,4.2.4,4.2.5Covered.ThedocumentationrequiredinthisEuropeanStandardcoversthequalitysystemdocumentationmeantin3.2ofAnnex5whentheexplicitlegalrequirementsareincorporatedintothequalitysys
43、temdocumentation.Seealsocoverageof3.2below.3.1,2ndparagraph,3rdindent4.1,5.1,5A5.5,5.6Covered.3.1,2ndparagraph,4thindent4.1,5.1,5A5.5,5.6Covered.3.1,2ndparagraph,5thindent4.1A2Coveredinpartprovidedthatqualitymanagementsystemincludesthetechnicaldocumentationrelatingtotheapplicableapprovedtype(s)ofmed
44、icaldevice(s).ReferencetotheECtype-examinationcertificateisnotcovered.3.1,2ndparagraph,6thindentNotcovered.ThisEuropeanStandardincludesrequirementsonpostmarketsurveillance,andreportingadverseeventsandfieldsafetycorrectiveactionstoauthoritiesbutdoesnotcoverallthedetailsrequiredbytheDirectiveincluding
45、timescalesforreporting3.2,1stparagraphNotcovered.ReferencetotheECtype-examinationcertificateisnotcovered.3.2,2ndparagraph4.1,4.2Covered.3.2,3rdparagraph(a)4.2.1,4.2.3,5.1,535.4.1Covered.3.2,3rdparagraph(b),1stindentfqi,5.5Covered.3.2,3rdparagraph(b),2ndindent4.1,5.6,7.1,8.2.4,8.3,8.4,8.5.2,8.5.3Cove
46、redprovidedthatthemethodsandacceptancecriteriachosenbythemanufacturerensurethattherequirementsoftheDirectivearefulfilled.3.2,3rdparagraph(b),3rdindent1.4.1,4.2,7.4,8.5.1Covered.3.2,3rdparagraph(c),1stindent4.2,6.4,7.1,7A7.5Coveredprovidedthatthequalitymanagementsystemdocumentationincludesrelevantdoc
47、umentsandrecordsinregardstosterilizationandpurchasing.ParagraphofDirective90/385/EEC,Annex5Clause(s)ofthisEuropeanStandardCominentsZQuaIifyingremarks3.2,3rdparagraph(c),2ndindent4.2,7.5.3Covered.3.2,3rdparagraph(d)7.1,7.4.3,7.6,8.2.6Coveredprovidedthatthefrequencyatwhichtestsarecarriedoutisdocumente
48、dinthequalitymanagementsystemdocumentation.WARNING1-PresumptionofconformitystaysvalidonlyaslongasareferencetothisEuropeanStandardismaintainedinthelistpublishedintheOfficialJournaloftheEuropeanUnion.UsersofthisstandardshouldconsultfrequentlythelatestlistpublishedintheOfficialJournaloftheEuropeanUnion.WARNING2OtherUnionlegislationmaybeapplicabl
