BS EN ISO 14971：2012 医疗器械 风险管理对医疗器械的应用（英文版）

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1、BSENISO14971:2012BSIStandardsPublicationMedicaldevices—Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW™raisingstandardsworldwideBSENISO14971:2012BRITISHSTANDARDNationalfor

2、ewordThisBritishStandardistheUKimplementationofENISO14971:2012.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2009whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210/4,RiskanalysisforMedicalDevices.Alistoforganizationsrepres

3、entedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2012.PublishedbyBSIStandardsLimited2012ISBN9780580799525ICS11.

4、040.01CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2012.AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEU

5、ROPÄISCHENORMJuly2012ICS11.040.01SupersedesENISO14971:2009EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagements

6、aufauxdispositifsmédicaux(ISO14971:2007,VersionMedizinprodukte(ISO14971:2007,korrigierteFassungcorrigéede2007-10-01)2007-10-01)ThisEuropeanStandardwasapprovedbyCENon16May2012.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatethecond

7、itionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexists

8、inthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCE