BS-EN-ISO-14971-2009-医疗器械.医疗器械风险管理的应用

raisingstandardsworldwide™NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSIBritishStandardsMedicaldevices—ApplicationofriskmanagementtomedicaldevicesBSENISO14971:2009NationalforewordThisBritishStandardistheUKimplementationofENISO14971:2009.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2007whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©BSI2009ISBN9780580672675ICS11.040.01CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2009AmendmentsissuedsincepublicationDateTextaffectedBRITISHSTANDARDBSENISO14971:2009EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO14971July2009ICS11.040.01SupersedesENISO14971:2007EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-Applicationdelagestiondesrisquesauxdispositifsmédicaux(ISO14971:2007,Versioncorrigéede2007-10-01)Medizinprodukte-AnwendungdesRisikomanagementsaufMedizinprodukte(ISO14971:2007,korrigierteFassung2007-10-01)ThisEuropeanStandardwasapprovedbyCENon13June2009.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENorCENELECmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommittees,respectively,ofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.CENManagementCentre:CENELECCentralSecretariat:AvenueMarnix17,B-1000BrusselsAvenueMarnix17,B-1000Brussels©2009CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembersandforCENELECMembers.Ref.No.ENISO14971:2009EENISO14971:2009(E)3ForewordThetextofISO14971:2007,Correctedversion2007-10-01hasbeenpreparedbyTechnicalCommitteeISO/TC210“Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices”oftheInternationalOrganizationforStandardization(ISO)andhasbeentakenoverasENISO14971:2009byTechnicalCommitteeCEN/CLCTC3“Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices”thesecretariatofwhichisheldbyNEN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyJanuary2010,andconflictingnationalstandardsshallbewithdrawnatthelatestbyMarch2010.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CEN[and/orCENELEC]shallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO14971:2007.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirectives93/42/EEConMedicalDevices,90/385/EEConActiveImplantableMedicalDevicesand98/79/EConInVitroDiagnosticDevices.ForrelationshipwithEUDirectives,seeinformativeAnnexesZA,ZBandZC,whichareanintegralpartofthisdocument.ThepresentstandardcanalsobeusedtosupportsomepartsoftheconformityassessmentproceduresdescribedinannexesoftheEuropeanmedicaldevicesdirectives(90/385/EEC,93/42/EECand(98/79/EC):−anadequatedescriptionof:resultsoftheriskanalysis,−anundertakingbythemanufacturertoinstituteandkeepuptodateasystematicproceduretoreviewexperiencegainedfromdevicesinthepost-productionphaseandtoimplementappropriatemeanstoapplyanynecessarycorrectiveactionNOTE:OtherrequirementsmaybeapplicabletothisaspectInestablishingthepolicyfordeterminingriskacceptabilitycriteria,thisstandardallowsmanufacturerstochoosefromarangeofoptionswithinthosepermittedbyregulations(seeclause3.2).Europeanmedicaldevicesdirectivesrequirethat,inselectingthemostappropriatesolutionsforthedesignandconstructionofthedevices,thesesolutionsmustconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart,andthemanufacturermustapplythefollowingprinciplesinthefollowingorder:•eliminateorreducerisksasfaraspossible(inherentlysafedesignandconstruction),•whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated,•informusersoftheresi