BS EN ISO 14971-2012 医疗器械 风险管理对医疗器械的应用

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1、BSENISO14971:2012BSIStandardsPublicationMedicaldevices—Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWLicensedcopy:TheUniversityofHongKong,TheUniversityofHongKon

2、g,Versioncorrectasof24/09/201202:35,(c)TheBritishStandardsInstitution2012™raisingstandardsworldwideBSENISO14971:2012BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationofENISO14971:2012.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:

3、2009whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210/4,RiskanalysisforMedicalDevices.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecess

4、aryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2012.PublishedbyBSIStandardsLimited2012ISBN9780580799525ICS11.040.01CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardw

5、aspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2012.AmendmentsissuedsincepublicationDateTextaffectedLicensedcopy:TheUniversityofHongKong,TheUniversityofHongKong,Versioncorrectasof24/09/201202:35,(c)TheBritishStandardsInstitution20

6、12EUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMJuly2012ICS11.040.01SupersedesENISO14971:2009EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-Applicationdelagestion

7、desrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO14971:2007,VersionMedizinprodukte(ISO14971:2007,korrigierteFassungcorrigéede2007-10-01)2007-10-01)ThisEuropeanStandardwasapprovedbyCENon16May2012.CENandCENELECmembersareboundt

8、ocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalrefer