IEC60601-1-6-Edition-3-检查表-(英文)

ClauseRequirementApplies?(yes/no/na)ReferencetoDocumentation4.1(60601-1-6)4.1.1TheusabilityPROCESSshalladdressOPERATORinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:-62366–transport;–storage;–installation;–operation;–maintenanceandrepair;and–disposal.4.1.2-623664.1.3-623664.2AUsabilityEngineeringProcesscompliantwith62366shallbeappliedusingthefollowingterms:(60601-1-6)–Theterm“MEDICALDEVICE”shallassumethesamemeaningasMEEQUIPMENT.–Theterm“USER”shallassumethesamemeaningasOPERATOR.–Theterm“PATIENT”shallincludeanimals.–ThetermSAFETY”shallassumethesamemeaningasBASICSAFETYandESSENTIALPERFORMANCE.–Theterm“USERINTERFACE”shallassumethesamemeaningasOPERATOR-EQUIPMENTINTERFACE.–Theterm“USERPROFILE”shallassumethesamemeaningasOPERATORPROFILE.TheUSABILITYENGINEERINGFILEshall:–establishedaUSABILITYENGINEERINGPROCESS;–establishedacceptancecriteriaforUSABILITY;and–demonstratedthattheacceptancecriteriaforUSABILITYhavebeenmet.4.2-623664.3-62366Riskanalysesshallincorporate/considerthefollowing:–applicationspecification–OPERATORPROFILE;–predictableUSEERRORS–*taskrelatedrequirements;–*contextofuse;–informationonHAZARDSknownforexistingOPERATOR-EQUIPMENTINTERFACESforMEEQUIPMENTofasimilartype–resultsofthereviewoftheOPERATOR-EQUIPMENTINTERFACEEquipmentprovidesadequateusability,andtherisksresultingfromnormaluseanduseerrorsareacceptableYesusermanualWheretherequirementsof60601-1-6and62366havebeenapplied,risksassociatedwithusabilityshallbeconsideredacceptableaccordingtoISO14971Whereinformationforsafetyisusedtocontrolriskstheprocessdefinedin60601-1-6and62366shallbeappliedtothatinformation.ResultsoftheusabilityengineeringprocessrecordedintheusabilityengineeringfileTheUsabilityengineeringprocessmaybescaledbasedonthetypeandcomplexityofthedeviceorwheremodificationsarebeingmadetoanexistingdesign.4.2IEC60601-1-6Edition3checklist(3rdEdition)ClauseRequirementApplies?(yes/no/na)ReferencetoDocumentationIEC60601-1-6Edition3checklist(3rdEdition)5(60601-1-6)5.1-62366–medicalpurposesuchasconditions(s)ordisease(s)tobescreened,monitored,treated,ordiagnosed:–patientpopulationsuchasage,weight,regionofbody,health,andcondition:–partofthebodyortypeoftissueappliedtoorinteractedwith:–intendedOPERATORprofile:–applicationsuchasenvironment,frequencyofuse,location,andmobility:5.2-623665.3.1AnidentificationofcharacteristicsrelatedtoSAFETY(partofaRISKANALYSIS)thatfocusesonUSABILITYshallbeperformedaccordingtoISO14971:2007,4.2.Theseshallconsideratminimum:-62366–applicationspecification,includingUSERPROFILE(S);and–frequentlyusedfunctionsTheresultsofthisidentificationcharacteristicsrelatedtoSAFETYshallberecordedintheUSABILITYENGINEERINGFILE.5.3.2TheMANUFACTURERshallidentifyknownorforeseeableHAZARDS(partofaRISKANALYSIS)toPATIENTS,USERSandotherpersonsin-62366reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATION.TheSEVERITYoftheresultingpossibleHARMshallbedeterminedanddocumentedaspartoftheriskanalysisandintheUSABILITYENGINEERINGFILE.DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingshallbeconsidered:–applicationspecification,includingUSERPROFILE(S)–taskrelatedrequirements;–contextofuse;–informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESofMEDICALDEVICESofasimilartype,ifavailable;–preliminaryUSESCENARIOS;–possibleUSEERRORS–ifanincorrectmentalmodeloftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;and–resultsofthereviewoftheUSERINTERFACE5.4-62366TheinputstothePRIMARYOPERATINGFUNCTIONSidentificationshallincludethefollowing:Ifprovided,theinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformancecharacteristicsrelevanttoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.Applicationoftheequipmentisspecifiedintheusabilityengineeringfile,andthespecificationsincludethefollowinginformation:TheMANUFACTURERshalldeterminethefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEandrecordthemintheUSABILITYENGINEERINGFILETheMANUFACTURERshalldeterminethePRIMARYOPERATINGFUNCTIONSandrecordthemintheUSABILITYENGINEERINGFILE.ClauseRequirementApplies?(yes/no/na)ReferencetoDocumentationIEC60601-1-6Edition3checklist(3rdEdition)–frequentlyusedfunctionsand–functionsrelatedtoSAFETYoftheMEDICALDEVICE.5.5TheMANUFACTURERshalldeveloptheUSABILITYSPECIFICATION.TheUSABILITYSPECIFICATIONshallprovide:-62366–testablerequirementsforUSABILITYVERIFICATION;and–testablerequirementsforUSABILITYofthePRIMARYOPERATINGFUNCTIONSincludingcriteriafordeterminingtheadequacyofRISKCONTROLachievedbytheUSABILITYENGINEERINGPROCESS.TheinputstotheUSABILITYSPECIFICATIONshallincludethefollowing:–applicationspecification–PRIMARYOPERATINGFUNCTIONS–HAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY;and–knownorforeseeableUSEERRORSassociatedwiththeMEDICALDEVICE.TheUSABILITYSPECIFICATIONshalldescribeatleast:–USESCENARIOSrelatedtot