BS EN ISO 14971-2009 医疗器械.医疗器械风险管理的应用.pdf

《BS EN ISO 14971-2009 医疗器械.医疗器械风险管理的应用.pdf》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、BSENISO14971:2009BSIBritishStandardsMedicaldevicesÐApplicationofriskmanagementtomedicaldevicesNOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW™raisingstandardsworldwideBSENISO14971:2009BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementatio

2、nofENISO14971:2009.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2007whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis

3、.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©BSI2009ISBN9780580672675ICS11.040.01CompliancewithaBritishStand

4、ardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2009AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMJuly2009ICS11.040.0

5、1SupersedesENISO14971:2007EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO1

6、4971:2007,VersionMedizinprodukte(ISO14971:2007,korrigierteFassungcorrigéede2007-10-01)2007-10-01)ThisEuropeanStandardwasapprovedbyCENon13June2009.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropean

7、Standardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,Fr

8、ench,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENorCENELECmemberintoitsownlanguageandnotifiedtot