ISO13485-2016英文版可编辑.docx

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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,withinthelimitsofthescopeofthisEur