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

BSENISO14971:2009BSIBritishStandardsMedicaldevices—ApplicationofriskmanagementtomedicaldevicesNOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWraisingstandardsworldwide™BSENISO14971:2009BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationofENISO14971:::,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,mitteeCH/210/4,.©ÉENNEEUROPÄ:2007EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-ApplicationdelagestiondesrisquesMedizinprodukte-AnwendungdesRisikomanagementsaufauxdispositifsmédicaux(ISO14971:2007,VersionMedizinprodukte(ISO14971:2007,korrigierteFassungcorrigéede2007-10-01)2007-10-01)-to-(English,French,German).,respectively,ofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,herlands,Norway,Poland,Portugal,Romania,Slovakia,Slov