[医疗质量标准]ISO14971-2007 ENG-Medical devices(英文版)

l� �����CopyrightBritishStandardProvidedbyIHSunderliceNoreproductionornetwork��������� ����� ���������������������������������������������sInstitution--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---nsewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTingpermittedwithoutlicensefromIHSdevicesTheEuropeanStandardENISO14971:2007hasthestatusofaBritishStandardICS11.040.01Medicaldevices—ApplicationofriskmanagementtomedicaBRITISHSTANDARDBSENISO14971:2007BSENISO14971:20CopProNo-`-`,,`,,`,`,,`---ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30April2007©BSI2007ISBN9780580506055yrightBritishStandardsInstitutionvidedbyIHSunderlicensewithBSI-UncontrolledCopyreproductionornetworkingpermittedwithoutlicensefrom--```,,,```,``,`,`,`,,,``,AmendmentsissuedsincepublicationAmd.No.DateCommentsThispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.07NationalforewordThisBritishStandardwaspublishedbyBSI.ItistheUKimplementationofENISO14971:2007.ItsupersedesBSENISO14971:2001whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedbyTechnicalCommitteeCH/210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,toSubcommitteeCH/210/4,Riskanalysis.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Licensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTIHSEUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO14971March2007ICS11.040.01SupersedesENISO14971:2000EnglishVersionMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007)Dispositifsmédicaux-Applicationdelagestiondesrisquesauxdispositifsmédicaux(ISO14971:2007)Medizinprodukte-AnwendungdesRisikomanagementsaufMedizinprodukte(ISO14971:2007)ThisEuropeanStandardwasapprovedbyCENon9March2007.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,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.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITÉEUROPÉENDENORMALISATIONEUROPÄISCHESKOMITEEFÜRNORMUNGManagementCentre:ruedeStassart,36B-1050Brussels©2007CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.Ref.No.ENISO14971:2007:ECopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---ForewordThetextoftheInternationalStandardISO/FDIS14971:2006hasbeenpreparedbyTechnicalCommitteeISO/TC210"Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,JointWorkingGroup1".ThetranspositionintoaEuropeanStandardhasbeenmanagedbytheCENManagementCentre(CMC)withtheassistanceoftheCENAdvisoryBoardforHealthStandards.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbySeptember2007,andconflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2007.ThisdocumentsupersedesENISO14971:2000.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s).ForrelationshipwithEssentialRequirementsinEUDirective(s),seeinformativeAnnexZA,whichisanintegralpartofthisdocument.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,•informusersoftheresidualrisksduetoanyshortcomingsoftheprotectionmeasuresadopted.Inthiscontext,‘eliminating’or‘reducing’riskmustbeinterpretedandappliedinsuchawayastotakeaccountoftechnologyandpracticeexistingatthetimeofdesignandoftechnicalandeconomicalconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;(seealsoAnnexD.8).AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,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.EndorsementnoticeThetextofISO14971:2007hasbeenapprovedbyCENasENISO14971:2007withoutanymodifications.ENISO14971:2007CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---ReferencenumberISO14971:2007(E)INTERNATIONALSTANDARDISO14971Secondedition2007-03-01Medicaldevices—ApplicationofriskmanagementtomedicaldevicesDispositifsmédicaux—ApplicationdelagestiondesrisquesauxdispositifsmédicauxENISO14971:2007CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---iiCopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---iiiContentsPageForeword............................................................................................................................................................ivIntroduction........................................................................................................................................................v1Scope.....................................................................................................................................................12Termsanddefinitions...........................................................................................................................13Generalrequirementsforriskmanagement......................................................................................53.1Riskmanagementprocess..................................................................................................................53.2Managementresponsibilities..............................................................................................................73.3Qualificationofpersonnel...................................................................................................................73.4Riskmanagementplan.........................................................................................................................73.5Riskmanagementfile...........................................................................................................................84Riskanalysis.........................................................................................................................................84.1Riskanalysisprocess..........................................................................................................................84.2Intendeduseandidentificationofcharacteristicsrelatedtothesafetyofthemedicaldevice.....................................................................................................................................................94.3Identificationofhazards......................................................................................................................94.4Estimationoftherisk(s)foreachhazardoussituation.....................................................................95Riskevaluation....................................................................................................................................106Riskcontrol.........................................................................................................................................116.1Riskreduction.....................................................................................................................................116.2Riskcontroloptionanalysis..............................................................................................................116.3Implementationofriskcontrolmeasure(s)......................................................................................116.4Residualriskevaluation.....................................................................................................................126.5Risk/benefitanalysis..........................................................................................................................126.6Risksarisingfromriskcontrolmeasures........................................................................................126.7Completenessofriskcontrol............................................................................................................127Evaluationofoverallresidualriskacceptability.............................................................................138Riskmanagementreport....................................................................................................................139Productionandpost-productioninformation..................................................................................13AnnexA(informative)Rationaleforrequirements.......................................................................................15AnnexB(informative)Overviewoftheriskmanagementprocessformedicaldevices..........................23AnnexC(informative)Questionsthatcanbeusedtoidentifymedicaldevicecharacteristicsthatcouldimpactonsafety.......................................................................................................................25AnnexD(informative)Riskconceptsappliedtomedicaldevices..............................................................32AnnexE(informative)Examplesofhazards,foreseeablesequencesofeventsandhazardoussituations.............................................................................................................................................49AnnexF(informative)Riskmanagementplan..............................................................................................54AnnexG(informative)Informationonriskmanagementtechniques.........................................................56AnnexH(informative)Guidanceonriskmanagementforinvitrodiagnosticmedicaldevices..............60AnnexI(informative)Guidanceonriskanalysisprocessforbiologicalhazards.....................................76AnnexJ(informative)Informationforsafetyandinformationaboutresidualrisk...................................78Bibliography.....................................................................................................................................................80AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirectives93/42/EECMedicalDevices,90/385/EECActiveImplantableMedicalDevicesand98/79/ECInVitroDiagnosticDevices...........................................................83ENISO14971:2007CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---ivForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.ThemaintaskoftechnicalcommitteesistoprepareInternationalStandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.InternationalStandardISO14971waspreparedbyISO/TC210,Qualitymanagementandcorrespondinggeneralaspectsformedicaldevices,andSubcommitteeIEC/SC62A,Commonaspectsofelectricalequipmentusedinmedicalpractice.AnnexH,“Guidanceonriskmanagementforinvitrodiagnosticmedicaldevices”,waspreparedbyISO/TC212,Clinicallaboratorytestingandinvitrodiagnostictestsystems.Thissecondeditioncancelsandreplacesthefirstedition(ISO14971:2000)aswellastheamendmentISO14971:2000/Amd.1:2003.ForpurposesoffutureIECmaintenance,Subcommittee62Ahasdecidedthatthecontentsofthispublicationwillremainunchangeduntilthemaintenanceresultdate1)indicatedontheIECwebsiteunderhttp://webstore.iec.chinthedatarelatedtothespecificpublication.Atthisdate,thepublicationwillbe⎯reconfirmed,⎯withdrawn,⎯replacedbyarevisededitionor⎯amended.1)IECNationalCommitteesarerequestedtonotethatforthispublicationthemaintenanceresultdateis2014.ENISO14971:2007CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---vIntroductionTherequirementscontainedinthisInternationalStandardprovidemanufacturerswithaframeworkwithinwhichexperience,insightandjudgmentareappliedsystematicallytomanagetherisksassociatedwiththeuseofmedicaldevices.ThisInternationalStandardwasdevelopedspecificallyformedicaldevice/systemmanufacturersusingestablishedprinciplesofriskmanagement.Forothermanufacturers,e.g.,inotherhealthcareindustries,thisInternationalStandardcouldbeusedasinformativeguidanceindevelopingandmaintainingariskmanagementsystemandprocess.ThisInternationalStandarddealswithprocessesformanagingrisks,primarilytothepatient,butalsototheoperator,otherpersons,otherequipmentandtheenvironment.Asageneralconcept,activitiesinwhichanindividual,organizationorgovernmentisinvolvedcanexposethoseorotherstakeholderstohazardswhichcancauselossofordamagetosomethingtheyvalue.Riskmanagementisacomplexsubjectbecauseeachstakeholderplacesadifferentvalueontheprobabilityofharmoccurringanditsseverity.Itisacceptedthattheconceptofriskhastwocomponents:a)theprobabilityofoccurrenceofharm;b)theconsequencesofthatharm,thatis,howsevereitmightbe.Theconceptsofriskmanagementareparticularlyimportantinrelationtomedicaldevicesbecauseofthevarietyofstakeholdersincludingmedicalpractitioners,theorganizationsprovidinghealthcare,governments,industry,patientsandmembersofthepublic.Allstakeholdersneedtounderstandthattheuseofamedicaldeviceentailssomedegreeofrisk.Theacceptabilityofarisktoastakeholderisinfluencedbythecomponentslistedaboveandbythestakeholder’sperceptionoftherisk.Eachstakeholder’sperceptionoftheriskcanvarygreatlydependingupontheirculturalbackground,thesocio-economicandeducationalbackgroundofthesocietyconcerned,theactualandperceivedstateofhealthofthepatient,andmanyotherfactors.Thewayariskisperceivedalsotakesintoaccount,forexample,whetherexposuretothehazardseemstobeinvoluntary,avoidable,fromaman-madesource,duetonegligence,arisingfromapoorlyunderstoodcause,ordirectedatavulnerablegroupwithinsociety.Thedecisiontouseamedicaldeviceinthecontextofaparticularclinicalprocedurerequirestheresidualriskstobebalancedagainsttheanticipatedbenefitsoftheprocedure.Suchjudgmentsshouldtakeintoaccounttheintendeduse,performanceandrisksassociatedwiththemedicaldevice,aswellastherisksandbenefitsassociatedwiththeclinicalprocedureorthecircumstancesofuse.Someofthesejudgmentscanbemadeonlybyaqualifiedmedicalpractitionerwithknowledgeofthestateofhealthofanindividualpatientorthepatient’sownopinion.Asoneofthestakeholders,themanufacturermakesjudgmentsrelatingtosafetyofamedicaldevice,includingtheacceptabilityofrisks,takingintoaccountthegenerallyacceptedstateoftheart,inordertodeterminethesuitabilityofamedicaldevicetobeplacedonthemarketforitsintendeduse.ThisInternationalStandardspecifiesaprocessthroughwhichthemanufacturerofamedicaldevicecanidentifyhazardsassociatedwithamedicaldevice,estimateandevaluatetherisksassociatedwiththesehazards,controltheserisks,andmonitortheeffectivenessofthatcontrol.Foranyparticularmedicaldevice,otherInternationalStandardscouldrequiretheapplicationofspecificmethodsformanagingrisk.ENISO14971:2007CopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---blankCopyrightBritishStandardsInstitutionProvidedbyIHSunderlicensewithBSI-UncontrolledCopyLicensee=HongKongPolytechnicUniv/9976803100NotforResale,06/24/200723:31:59MDTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,,,```,``,`,`,`,,,``,-`-`,,`,,`,`,,`---1Medicaldevices—Applicationofriskmanagementtomedicaldevices1ScopeThisInternationalStandardspecifiesaprocessforamanufacturertoidentifythehazardsassociatedwithmedicaldevices,includinginvitrodiagnostic(IVD)medicaldevices,toestimateandevaluatetheassociatedrisks,tocontroltheserisks,andtomonitortheeffectivenessofthecontrols.TherequirementsofthisInternationalStandardareapplicabletoallstagesofthelife-cycleofamedicaldevice.ThisInternationalStandarddoesnotapplytoclinicaldecisionmaking.ThisInternationalStandarddoesnotspecifyacceptablerisklevels.ThisInternationalStandarddoesnotrequirethatthemanufacturerhaveaqualitymanagementsysteminplace.However,riskmanagementcanbeanintegralpartofaqualitymanagementsystem.2TermsanddefinitionsForthepurposesofthisdocument,thefollowingtermsanddefinitionsapply:2.1accompanyingdocumentdocumentaccompanyingamedicaldeviceandcontai