BS EN ISO 14971-2009 医疗器械.医疗器械风险管理的应用

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1、BSENISO14971:2009BSIBritishStandardsMedicaldevicesÐApplicationofriskmanagementtomedicaldevicesNOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW™raisingstandardsworldwideBSENISO14971:2009BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementat

2、ionofENISO14971:2009.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2007whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanal

3、ysis.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©BSI2009ISBN9780580672675ICS11.040.01CompliancewithaBritis

4、hStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2009AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMJuly2009ICS

5、11.040.01SupersedesENISO14971:2007EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsméd

6、icaux(ISO14971:2007,VersionMedizinprodukte(ISO14971:2007,korrigierteFassungcorrigéede2007-10-01)2007-10-01)ThisEuropeanStandardwasapprovedbyCENon13June2009.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgiving

7、thisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversi

8、ons(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENorCENELECmemberintoitsownlanguageandnotifiedtot