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ID:40567084
大小:2.77 MB
页数:96页
时间:2019-08-04
《BS EN ISO 14971-2009打印》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、BSENISO14971:2009BSIBritishStandardsMedicaldevicesÐApplicationofriskmanagementtomedicaldevicesNOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAW™raisingstandardsworldwideBSENISO14971:2009BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationofENISO1
2、4971:2009.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2007whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis.Alistoforganizati
3、onsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©BSI2009ISBN9780580672675ICS11.040.01CompliancewithaBritishStandardcannotconferimmunityfrom
4、legalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2009AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDENISO14971NORMEEUROPÉENNEEUROPÄISCHENORMJuly2009ICS11.040.01SupersedesENISO14971:2007Englishver
5、sionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO14971:2007,VersionMedizinprodukte(ISO14971:200
6、7,korrigierteFassungcorrigéede2007-10-01)2007-10-01)ThisEuropeanStandardwasapprovedbyCENon13June2009.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalterati
7、on.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslationunderth
8、eresponsibilityofaCENorCENELECmemberintoitsownlanguageandnotifiedtot
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