ISO13485-2016英文版可编辑.docx

EUROPEANSTANDARDNORMEEUROPEENNEEuropAischeENISO13485March2016NORMICS03.120.10;11.040.01SupersedesENISO13485:2012EnglishversionMedicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2016)Dispositifsmcdicaux-SystcmesdemanagcmcnidelaMcdizinproduktc-Qualitatsmanagcmcntsystcmc-qualitd-ExigencesAdesfinsrcglcmcntaircs(ISOAnlbrdcrungcnfiirFCgUIaloriSChCZwcckc(ISO13485:2016)13485:2016)ThisEuropeanStandardwasapprovedbyCENon30January2016.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexistsinthreeofcialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENandCENELECmemberintoitsownlanguageandnotifiedtoheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Belgium.Bulgaria.Croatia,Cyprus,CzechRepublic.Denmark.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-100OBrussels©2016CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembersandforCENELECMembers.Ref.No.ENISO13485:2016EEuropeanforewordThisdocument(ENISO13485:2016)hasbeenpreparedbyTechnicalCommitteeISO/TC210"Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices"incollaborationwithTechnicalCommitteeCEN/CLC/TC3"Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices"thesecretarialofwhichisheldbyNEN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbySeptember2016,andconflictingnationalstandardsshallbewithdrawnatthelatestbyMarch2019.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENand/orCENELECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO13485:2012.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirectives.ForrelationshipwithEUDirectives,seeinformativeAnnexZA,ZBandZC,whichareintegralpartsofthisdocument.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria.Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,LatVia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland.Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandtheUnitedKingdom.Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.Fordatedreferences,onlytheeditioncitedapplies.However,foranyuseofthisstandardwithinthemeaningofAnnexZA,ZBandZC,theusershouldalwayscheckthatanyreferenceddocumenthasnotbeensupersededandthatitsrelevantcontentscanstillbeconsideredthegenerallyacknowledgedstate-of-art.WhenanIECorISOstandardisreferredtointheISOstandardtext,thisshallbeunderstoodasanormativereferencetothecorrespondingENstandard,ifavailable,andotherwisetothedatedversionoftheISOorIECstandard,aslistedbelow.NOTEThewayinwhichthesereferenceddocumentsarecitedinnormativerequirementsdeterminestheextent(inwholeorinpart)towhichtheyapply.Table1CorrelationbetweennormativereferencesanddatedENandISOstandardsNormativereferencesaslistedinClause2oftheISOstandardEquivalentCkENItedstandardISOISO9000:2015ENISO9000:2015ISO9000:2015EndorsementnoticeThetextofISO13485:2016hasbeenapprovedbyCENasENISO13485:2016withoutanymodification.AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirective90/385/EEC(asamended)ZA.OGeneralThisEuropeanstandardhasbeenpreparedunderaCommission'sstandardisationrequestM/023toprovideonevoluntarymeansofconformingtorequirementsofCouncilDirectiveof20June1990ontheapproximationofthelawsoftheMemberStatesrelatingtoactiveimplantablemedicaldevicesOJL189.OnccthisEuropeanStandardiscitedintheOfficialJournaloftheEuropeanUnionunderDirective90/385/EEC(asamended)andhasbeenimplementedasanationalstandardinatleastoneMemberState,compliancewiththenormativeclausesofthisEuropeanStandardgiveninTableZA.1orTableZA.2confer,withinthelimitsofthescopeofthisEur