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

raisingstandardsworldwide™NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSIStandardsPublicationBSENISO14971:2012Medicaldevices—Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)BSENISO14971:2012BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationofENISO14971:2012.ItisidenticaltoISO14971:2007.ItsupersedesBSENISO14971:2009whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210/4,RiskanalysisforMedicalDevices.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2012.PublishedbyBSIStandardsLimited2012ISBN9780580799525ICS11.040.01CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31July2012.AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO14971July2012ICS11.040.01SupersedesENISO14971:2009EnglishversionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)Dispositifsmédicaux-Applicationdelagestiondesrisquesauxdispositifsmédicaux(ISO14971:2007,Versioncorrigéede2007-10-01)Medizinprodukte-AnwendungdesRisikomanagementsaufMedizinprodukte(ISO14971:2007,korrigierteFassung2007-10-01)ThisEuropeanStandardwasapprovedbyCENon16May2012.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENandCENELECmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.CEN-CENELECManagementCentre:AvenueMarnix17,B-1000Brussels©2012CEN/CENELECRef.No.ENISO14971:2012E4AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandRequirementsofEUDirective93/42/EEConMedicalDevicesThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociationtoprovideameansofconformingtoRequirementsoftheNewApproachDirective93/42/EEConMedicalDevices.Withinthelimitsofthescopeofthisstandard(Clause1ofENISO14971:2012),compliancewiththeclausesofthisstandardconfersapresumptionofconformitywithrequirementsofthatDirectiveandassociatedEFTAregulations,oncethisstandardiscitedintheOfficialJournaloftheEuropeanUnionunderthatDirectiveandhasbeenimplementedasanationalstandardinatleastoneMemberState.ThisAnnexZAexplainstowhichrequirements,underwhichconditionsandtowhatextentpresumptionofconformitycanbeclaimed.Whilstonlyalimitednumberofrequirementsiscoveredjustbytheapplicationofthisstandard,authoritiesinchargeofmedicaldevicesstronglyrecommendusingthisstandard.Thestandardleads,accordingtoexperienceoftheauthorities,toahigherdegreeofcompliancewithlegalobligations.ENISO14971:2012providesaprocessformanagingrisksassociatedwithmedicaldevices.Becausethisstandarddescribesanongoing,lifecycleprocessapplicableinpartorinalltotheEssentialRequirementsofDirective93/42/EEConMedicalDevices,itis–veryexceptionally–notmeaningfultolinkindividualclausesofthestandardtospecificcorrespondingEssentialRequirements.CompliancewithallthenormativeclausesinENISO14971willensurethataprocessisinplacetoaddressgeneralriskmanagementaspectsrelatedtomedicaldevices,whichareincludedintheEssentialRequirements.However,becausethisisaninternationalstandard,intendedtobeapplicableinjurisdictionsallovertheworld,itisnottheprimarygoalofthestandardtocoverexactlyanyoftheEuropeanEssentialRequirements.Therefore,foralloftheEssentialRequirements,conformityisnotentirelyachievedbycomplyingonlywiththerequirementsspecifiedinthisstandard.ManufacturersandconformityassessmentbodieswillneedtofeedtheEssentialRequirementsintotheriskmanagementprocessprovidedbythestandard.ExplanationonthecorrespondenceofthestandardandtheEssentialRequirementsisincludedinTableZA.1.FurtherexplanationoncontentdeviationsbetweenthestandardandtheERsisprovidedbelowthetable.BSENISO14971:2012ENISO14971:2012(E)5�TableZA.1—CorrespondencebetweenthisEuropeanStandardandDirective93/42/EECClause(s)/subclause(s)ofthisENEssentialRequirements(ERs)ofDirective93/42/EECQualifyingremarks/Notes1-91ER1isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandmanufacture.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER1.Forcontentdeviations,seepoints1,2,3,4below.1-92-ThesecondsentenceofER2ispartlycoveredby6.2.Forcontentdeviations,seepoints1,2,3,5,6,7below.-TheotherpartsofER2arenotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandconstruction,nordoesitapplytheconceptof‘safetyprinciples’asintendedintheMDD.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER2.1-94ER4isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotapplytheconceptof‘safetyprinciples’asintendedintheMDD.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER4.1-95ER5isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesign,manufactureorpackaging.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER5.BSENISO14971:2012ENISO14971:2012(E)66.4,6.5and76ER6iscovered.However,forcontentdeviations,seepoints1,2,3,4below.1-97.1ER7.1isonlypartlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandmanufactureanddoesnotcoverperformancesandcharacteristicsrelatedthereto.Furthermore,itdoesnotprovidespecificrequirementsontheitemsthatmustbepaidparticularattention.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER7.1.Forcontentdeviations,seepoints1to7below.ContentdeviationsThefollowingaspectshavebeenidentifiedwherethestandarddeviatesormightbeunderstoodasdeviatingfromtheEssentialRequirements:1.Treatmentofnegligiblerisks:a)AccordingtostandardISO14971,themanufacturermaydiscardnegligiblerisks1.b)However,Sections1and2ofAnnexItoDirective93/42/EECrequirethatallrisks,regardlessoftheirdimension,needtobereducedasmuchaspossibleandneedtobebalanced,togetherwithallotherrisks,againstthebenefitofthedevice.c)Accordingly,themanufacturermusttakeallrisksintoaccountwhenassessingSections1and2ofAnnexItoDirective93/42/EEC.2.Discretionarypowerofmanufacturersastotheacceptabilityofrisks:a)ISO14971seemstoimplythatmanufacturershavethefreedomtodecideuponthethresholdforriskacceptability2andthatonlynon-acceptableriskshavetobeintegratedintotheoverallrisk-benefitanalysis3.b)However,Sections1and2ofAnnexItoDirective93/42/EECrequirethatallriskshavetobereducedasfaraspossibleandthatallriskscombined,regardlessofany"acceptability"assessment,needtobebalanced,togetherwithallotherrisks,againstthebenefitofthedevice.c)Accordingly,themanufacturermaynotapplyanycriteriaofriskacceptabilitypriortoapplyingSections1and2ofAnnexItoDirective93/42/EEC.�����������������������������������������������������������1ThisisexplicitlystatedinD.8.2.2Sections5,6.4,6.5,7:referencetothecriteriaset-upinthemanagementplanwhichisunderthediscretionofthemanufacturer(seeSections3.2,3.4d)).SeealsoD.4:"ThisInternationalStandarddoesnotspecifyacceptablerisk.Thatdecisionislefttothemanufacturer."3SeeD.6.1.�BSENISO14971:2012ENISO14971:2012(E)7�3.Riskreduction"asfaraspossible"versus"aslowasreasonablypracticable":a)AnnexD.8toISO14971,referredtoin3.4,containstheconceptofreducingrisks"aslowasreasonablypracticable"(ALARPconcept).TheALARPconceptcontainsanelementofeconomicconsideration.b)However,thefirstindentofSection2ofAnnexItoDirective93/42/EECandvariousparticularEssentialRequirementsrequireriskstobereduced"asfaraspossible"withouttherebeingroomforeconomicconsiderations.c)Accordingly,manufacturersandNotifiedBodiesmaynotapplytheALARPconceptwithregardtoeconomicconsiderations.4.Discretionastowhetherarisk-benefitanalysisneedstotakeplace:a)6.5ofISO14971says:"Iftheresidualriskisnotjudgedacceptableusingthecriteriaestablishedintheriskmanagementplanandfurtherriskcontrolisnotpracticable,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheresidualrisk."Clause7ofISO14971says:"Iftheoverallresidualriskisnotjudgedacceptableusingthecriteriaestablishedintheriskmanagementplan,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheoverallresidualrisk."Bothquotesimplythatanoverallrisk-benefitanalysisdoesnotneedtotakeplaceiftheoverallresidualriskisjudgedacceptablewhenusingthecriteriaestablishedintheriskmanagementplan.Equally,D.6.1says:"Arisk/benefitanalysisisnotrequiredbythisInternationalStandardforeveryrisk."b)AccordingtoSection1ofAnnexItoDirective93/42/EEC,anoverallrisk-benefitanalysismusttakeplaceinanycase,regardlessoftheapplicationofcriteriaestablishedinthemanagementplanofthemanufacturer.Furthermore,Section6ofAnnexItoDirective93/42/EECrequiresundesirableside-effectsto"constituteanacceptableriskwhenweighedagainsttheperformanceintended".c)Accordingly,themanufacturermustundertaketherisk-benefitanalysisfortheindividualriskandtheoverallrisk-benefitanalysis(weighingallriskscombinedagainstthebenefit)inallcases.5.Discretionastotheriskcontroloptions/measures:a)6.2ofISO14971obligesthemanufacturerto"useoneormoreofthefollowingriskcontroloptionsinthepriorityorderlisted:(a)inherentsafetybydesign;(b)protectivemeasuresinthemedicaldeviceitselforinthemanufacturingprocess;(c)informationforsafety"andleavesadiscretionastotheapplicationofthesethreeoptions:shallthesecondorthirdcontroloptionstillbeusedwhenthefirstwasused?6.4indicatesthatfurtherriskcontrolmeasuresdonotneedtobetakenif,afterapplyingoneofthecontroloptions,theriskisjudgedacceptableaccordingtothecriteriaoftheriskmanagementplan.b)However,thesecondsentenceofSection2ofAnnexItoDirective93/42/EECrequests"toconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart"and"toselectthemostappropriatesolutions"byapplyingcumulativelywhathasbeencalled"controloptions"or"controlmechanisms"inthestandard.c)Accordingly,themanufacturermustapplyallthe"controloptions"andmaynotstophisendeavoursifthefirstorthesecondcontroloptionhasreducedtherisktoan"acceptablelevel"(unlesstheadditionalcontroloption(s)do(es)notimprovethesafety).6.Deviationastothefirstriskcontroloption:a)6.2ofISO14971obligesthemanufacturerto"useoneormoreofthefollowingriskcontroloptionsinthepriorityorderlisted:(a)inherentsafetybydesign…"withoutdeterminingwhatismeantbythisterm.b)However,thefirstindentofthesecondsentenceofSection2ofAnnexItoDirective93/42/EECrequiresto"eliminateorreducerisksasfaraspossible(inherentlysafedesignandconstruction)".c)Accordingly,astheDirectiveismoreprecisethanthestandard,manufacturersmustapplytheformerandcannotrelypurelyontheapplicationofthestandard.7.Informationoftheusersinfluencingtheresidualrisk:a)Theresidualriskisin2.15andin6.4ofISO14971definedastheriskremainingafterapplicationoftheriskcontrolmeasures.6.2ofISO14971regards"informationforsafety"tobeacontroloption.BSENISO14971:2012ENISO14971:2012(E)8b)However,thelastindentofSection2ofAnnexItoDirective93/42/EECsaysthatusersshallbeinformedabouttheresidualrisks.Thisindicatesthat,accordingtoAnnexItoDirective93/42/EECandcontrarytotheconceptofthestandard,theinformationgiventotheusersdoesnotreducethe(residual)riskanyfurther.c)Accordingly,manufacturersshallnotattributeanyadditionalriskreductiontotheinformationgiventotheusers.ConformityassessmentproceduresENISO14971canalsobeusedtosupportthefollowingpartsofconformityassessmentproceduresintheEuropeanMedicalDevicesDirectives:−anadequatedescriptionofresultsoftheriskanalysis(includedintheriskmanagementfile,see3.5ofENISO14971:2012);−anundertakingbythemanufacturertoinstituteandkeepuptodateasystematicproceduretoreviewexperiencegainedfromdevicesinthepost-productionphaseandtoimplementappropriatemeanstoapplyanynecessarycorrectiveaction(seeClause9ofENISO14971:2012).NOTEOtherandmoredetailedrequirementsareapplicabletothisaspect.WARNING—OtherrequirementsandotherEUDirectivesmaybeapplicabletoaproductfallingwithinthescopeofthisstandard.BSENISO14971:2012ENISO14971:2012(E)9�AnnexZB(informative)RelationshipbetweenthisEuropeanStandardandRequirementsofEUDirective90/385/EEConActiveImplantableMedicalDevicesThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociationtoprovideameansofconformingtoRequirementsoftheNewApproachDirective90/385/EEConActiveImplantableMedicalDevices.Withinthelimitsofthescopeofthisstandard(Clause1ofENISO14971:2012),compliancewiththeclausesofthisstandardconfersapresumptionofconformitywithrequirementsofthatDirectiveandassociatedEFTAregulations,oncethisstandardiscitedintheOfficialJournaloftheEuropeanUnionunderthatDirectiveandhasbeenimplementedasanationalstandardinatleastoneMemberState.ThisAnnexZBexplainstowhichrequirements,underwhichconditionsandtowhatextentpresumptionofconformitycanbeclaimed.Whilstonlyalimitednumberofrequirementsiscoveredjustbytheapplicationofthisstandard,authoritiesinchargeofmedicaldevicesstronglyrecommendusingthisstandard.Thestandardleads,accordingtoexperienceoftheauthorities,toahigherdegreeofcompliancewithlegalobligations.ENISO14971:2012providesaprocessformanagingrisksassociatedwithmedicaldevices.Becausethisstandarddescribesanongoing,lifecycleprocessapplicableinpartorinalltotheEssentialRequirementsofDirective90/385/EEConActiveImplantableMedicalDevices,itis–veryexceptionally–notmeaningfultolinkindividualclausesofthestandardtospecificcorrespondingEssentialRequirements.CompliancewithallthenormativeclausesinENISO14971willensurethataprocessisinplacetoaddressgeneralriskmanagementaspectsrelatedtomedicaldevices,whichareincludedintheEssentialRequirements.However,becausethisisanInternationalStandard,intendedtobeapplicableinjurisdictionsallovertheworld,itisnottheprimarygoalofthestandardtocoverexactlyanyoftheEuropeanEssentialRequirements.Therefore,foralloftheEssentialRequirements,conformityisnotentirelyachievedbycomplyingonlywiththerequirementsspecifiedinthisstandard.ManufacturersandconformityassessmentbodieswillneedtofeedtheEssentialRequirementsintotheriskmanagementprocessprovidedbythestandard.ExplanationonthecorrespondenceofthestandardandtheEssentialRequirementsisincludedinTableZB.1.FurtherexplanationoncontentdeviationsbetweenthestandardandtheERsisprovidedbelowthetable.TableZB.1—CorrespondencebetweenthisEuropeanStandardandDirective90/385/EECClause(s)/subclause(s)ofthisENEssentialRequirements(ERs)ofDirective90/385/EECQualifyingremarks/Notes1-91ER1isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandmanufacture.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER1.Forcontentdeviations,seepoints1,2,3below.BSENISO14971:2012ENISO14971:2012(E)101-93ER3isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotapplytheconceptof‘safetyprinciples’asintendedintheAIMDD.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER3.1-94ER4isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesign,manufactureorpackaging.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER4.6.4,6.5and75ER5iscovered.However,forcontentdeviations,seepoints1,2,3,4below.1-96ER6isnotdirectlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandconstruction,nordoesitapplytheconceptof‘safetyprinciples’asintendedintheAIMDD.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER6.Forcontentdeviations,seepoint3below.1-99ER9isonlypartlycoveredbyENISO14971,sincethestandarddoesnotproviderequirementsondesignandmanufactureanddoesnotcoverperformancesandcharacteristicsrelatedthereto.Furthermore,itdoesnotprovidespecificrequirementsontheitemsthatmustbepaidparticularattention.However,thestandardprovidesatooltogeneratetheinformationthatisanecessarypreliminarystepforamanufacturertodemonstratethatthedeviceisinconformitywithER9.Forcontentdeviations,seepoints1to4below.�BSENISO14971:2012ENISO14971:2012(E)11�ContentdeviationsThefollowingaspectshavebeenidentifiedwherethestandarddeviatesormightbeunderstoodasdeviatingfromtheEssentialRequirements:1.Treatmentofnegligiblerisks:a)AccordingtoISO14971,themanufacturermaydiscardnegligiblerisks4.b)However,Sections1and6ofAnnexItoDirective90/385/EECrequirethatallrisks,regardlessoftheirdimension,needtobereducedasmuchaspossible.c)Accordingly,themanufacturermusttakeallrisksintoaccountwhenassessingSections1and6ofAnnexItoDirective90/385/EEC.2.Discretionarypowerofmanufacturersastotheacceptabilityofrisks:a)ISO14971seemstoimplythatmanufacturershavethefreedomtodecideuponthethresholdforriskacceptability5andthatonlynon-acceptableriskshavetobeintegratedintotheoverallrisk-benefitanalysis6.b)However,Sections1and6ofAnnexItoDirective90/385/EECrequirethatallriskshavetobereducedasfaraspossible.c)Accordingly,themanufacturermaynotapplyanycriteriaofriskacceptabilitypriortoapplyingSections1and6ofAnnexItoDirective90/385/EEC.3.Riskreduction"asfaraspossible"versus"aslowasreasonablypracticable":a)D.8ofISO14971,referredtoin3.4,containstheconceptofreducingrisks"aslowasreasonablypracticable"(ALARPconcept).TheALARPconceptcontainsanelementofeconomicconsideration.b)However,variousEssentialRequirementsrequireriskstobereduced"asfaraspossible"withouttherebeingroomforeconomicconsiderations.c)Accordingly,manufacturersandNotifiedBodiesmaynotapplytheALARPconceptwithregardtoeconomicconsiderations.4.Discretionastowhetherarisk-benefitanalysisneedstotakeplace:a)6.5ofISO14971says:"Iftheresidualriskisnotjudgedacceptableusingthecriteriaestablishedintheriskmanagementplanandfurtherriskcontrolisnotpracticable,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheresidualrisk."Clause7ofISO14971says:"Iftheoverallresidualriskisnotjudgedacceptableusingthecriteriaestablishedintheriskmanagementplan,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheoverallresidualrisk."Bothquotesimplythatanoverallrisk-benefitanalysisdoesnotneedtotakeplaceiftheoverallresidualriskisjudgedacceptablewhenusingthecriteriaestablishedintheriskmanagementplan.Equally,D.6.1says:"Arisk-benefitanalysisisnotrequiredbythisInternationalStandardforeveryr