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1、BRITISHSTANDARDBSENISO14971:2007Medicaldevices—ApplicationofriskmanagementtomedicaldevicesTheEuropeanStandardENISO14971:2007hasthestatusofaBritishStandardICS11.040.01--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---
CopyrightBrit
2、ishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NoreproductionornetworkingpermittedwithoutlicensefromIHSNotforResale,06/24/200723:31:59MDTBSENISO14971:2007NationalforewordThisBritishStandardwaspublishedbyBSI.ItistheUKimple
3、mentationofENISO14971:2007.ItsupersedesBSENISO14971:2001whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedbyTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis.Alistoforganizationsrepresentedonthiscommi
4、tteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---ThisBritishSta
5、ndardwasAmendmentsissuedsincepublicationpublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeAmd.No.DateCommentson30April2007©BSI2007ISBN9780580506055CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/99768031
6、00NoreproductionornetworkingpermittedwithoutlicensefromIHSNotforResale,06/24/200723:31:59MDTEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMMarch2007ICS11.040.01SupersedesENISO14971:2000EnglishVersionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007)Disposit
7、ifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO14971:2007)Medizinprodukte(ISO14971:2007)ThisEuropeanStandardwasapprovedbyCENon9March2007.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegula
