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1、BRITISHSTANDARDBSENISO14971:2007Medicaldevices—ApplicationofriskmanagementtomedicaldevicesTheEuropeanStandardENISO14971:2007hasthestatusofaBritishStandardICS11.040.01--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---
CopyrightBritishStanda
2、rdsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NoreproductionornetworkingpermittedwithoutlicensefromIHSNotforResale,06/24/200723:31:59MDTBSENISO14971:2007NationalforewordThisBritishStandardwaspublishedbyBSI.ItistheUKimplementationofENISO14
3、971:2007.ItsupersedesBSENISO14971:2001whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedbyTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequestt
4、oitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---ThisBritishStandardwasAmendmentsissuedsincepublica
5、tionpublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeAmd.No.DateCommentson30April2007©BSI2007ISBN9780580506055CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100Noreproductionornetworkingpermittedwithoutl
6、icensefromIHSNotforResale,06/24/200723:31:59MDTEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMMarch2007ICS11.040.01SupersedesENISO14971:2000EnglishVersionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinpro
7、dukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO14971:2007)Medizinprodukte(ISO14971:2007)ThisEuropeanStandardwasapprovedbyCENon9March2007.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegula
