《ISO13485-2016英文版可编辑.docx》由会员分享，可在线阅读，更多相关《ISO13485-2016英文版可编辑.docx（56页珍藏版）》请在第壹文秘上搜索。
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
