2025年IEC60601-1-6-Edition-3-检查表-英文表格

IEC60601-1-6Edition3checklist(3rdEdition),,,

Clause,Requirement,Applies?(yes/no/na),ReferencetoDocumentation

4.1,"Equipmentprovidesadequateusability,andtherisksresultingfromnormaluseanduseerrorsareacceptable",Yes,usermanual

(60601-1-6),,,

4.1.1,"TheusabilityPROCESSshalladdressOPERATORinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:",,

-62366,–transport;,,

,–storage;,,

,–installation;,,

,–operation;,,

,–maintenanceandrepair;and,,

,–disposal.,,

4.1.2,"Wheretherequirementsof60601-1-6and62366havebeenapplied,risksassociatedwithusabilityshallbeconsideredacceptableaccordingtoISO14971",,

-62366,,,

4.1.3,Whereinformationforsafetyisusedtocontrolriskstheprocessdefinedin60601-1-6and62366shallbeappliedtothatinformation.,,

-62366,,,

4.2,AUsabilityEngineeringProcesscompliantwith62366shallbeappliedusingthefollowingterms:,,

(60601-1-6),–Theterm“MEDICALDEVICE”shallassumethesamemeaningasMEEQUIPMENT.,,

,–Theterm“USER”shallassumethesamemeaningasOPERATOR.,,

,–Theterm“PATIENT”shallincludeanimals.,,

,"–Theterm""SAFETY”shallassumethesamemeaningasBASICSAFETYandESSENTIAL",,

,PERFORMANCE.,,

,–Theterm“USERINTERFACE”shallassumethesamemeaningasOPERATOR-EQUIPMENT,,

,INTERFACE.,,

,–Theterm“USERPROFILE”shallassumethesamemeaningasOPERATORPROFILE.,,

,TheUSABILITYENGINEERINGFILEshall:,,

,–establishedaUSABILITYENGINEERINGPROCESS;,,

,–establishedacceptancecriteriaforUSABILITY;and,,

,–demonstratedthattheacceptancecriteriaforUSABILITYhavebeenmet.,,

4.2,Resultsoftheusabilityengineeringprocessrecordedintheusabilityengineeringfile,,

-62366,,,

4.3,TheUsabilityengineeringprocessmaybescaledbasedonthetypeandcomplexityofthedeviceorwheremodificationsarebeingmadetoanexistingdesign.,,

-62366,,,

4.2,Riskanalysesshallincorporate/considerthefollowing:,,

,–applicationspecification,,

,–OPERATORPROFILE;,,

,–predictableUSEERRORS,,

,–*taskrelatedrequirements;,,

,–*contextofuse;,,

,–informationonHAZARDSknownforexistingOPERATOR-EQUIPMENTINTERFACESforMEEQUIPMENTofasimilartype,,

,–resultsofthereviewoftheOPERATOR-EQUIPMENTINTERFACE,,

5,"Ifprovided,theinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformancecharacteristicsrelevanttoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.",,

(60601-1-6),,,

5.1,"Applicationoftheequipmentisspecifiedintheusabilityengineeringfile,andthespecificationsincludethefollowinginformation:",,

-62366,,,

,"–medicalpurposesuchasconditions(s)ordisease(s)tobescreened,monitored,treated,ordiagnosed:",,

,"–patientpopulationsuchasage,weight,regionofbody,health,andcondition:",,

,–partofthebodyortypeoftissueappliedtoorinteractedwith:,,

,–intendedOPERATORprofile:,,

,"–applicationsuchasenvironment,frequencyofuse,location,andmobility:",,

5.2,TheMANUFACTURERshalldeterminethefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEandrecordthemintheUSABILITYENGINEERINGFILE,,

-62366,,,

5.3.1,"AnidentificationofcharacteristicsrelatedtoSAFETY(partofaRISKANALYSIS)thatfocusesonUSABILITYshallbeperformedaccordingtoISO14971:2007,4.2.Theseshallconsideratminimum:",,

-62366,"–applicationspecification,includingUSERPROFILE(S);and",,

,–frequentlyusedfunctions,,

,TheresultsofthisidentificationcharacteristicsrelatedtoSAFETYshallberecordedintheUSABILITYENGINEERINGFILE.,,

5.3.2,"TheMANUFACTURERshallidentifyknownorforeseeableHAZARDS(partofaRISKANALYSIS)toPATIENTS,USERSandotherpersonsin",,

-62366,reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATION.TheSEVERITYoftheresultingpossibleHARMshallbedeterminedanddocumentedaspartoftheriskanalysisandintheUSABILITYENGINEERINGFILE.,,

,"DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingshallbe",,

,considered:,,

,"–applicationspecification,includingUSERPROFILE(S)",,

,–taskrelatedrequirements;,,

,–contextofuse;,,

,–informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESof,,

,"MEDICALDEVICESofasimilartype,ifavailable;",,

,–preliminaryUSESCENARIOS;,,

,–possibleUSEERRORS,,

,–ifanincorrectmentalmodeloftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;and,,

,–resultsofthereviewoftheUSERINTERFACE,,

5.4,TheMANUFACTURERshalldeterminethePRIMARYOPERATINGFUNCTIONSandrecordthemintheUSABILITYENGINEERINGFILE.,,

-62366,,,

,TheinputstothePRIMARYOPERATINGFUNCTIONSidentificationshallincludethefollowing:,,

,–frequentlyusedfunctionsand,,

,–functionsrelatedtoSAFETYoftheMEDICALDEVICE.,,

5.5,TheMANUFACTURERshalldeveloptheUSABILITYSPECIFICATION.TheUSABILITYSPECIFICATIONshallprovide:,,

-62366,–testablerequirementsforUSABILITYVERIFICATION;and,,

,–testablerequirementsforUSABILITYofthePRIMARYOPERATINGFUNCTIONSincludingcriteriafordeterminingtheadequacyofRISKCONTROLachievedbytheUSABILITYENGINEERING,,

,PROCESS.,,

,TheinputstotheUSABILITYSPECIFICATIONshallincludethefollowing:,,

,–applicationspecification,,

,–PRIMARYOPERATINGFUNCTIONS,,

,–HAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY;and,,

,–knownorforeseeableUSEERRORSassociatedwiththeMEDICALDEVICE.,,

,TheUSABILITYSPECIFICATIONshalldescribeatleast:,,

,"–USESCENARIOSrelatedtothePRIMARYOPERATINGFUNCTIONS,including;",,

,–frequentUSESCENARIOS;and,,

,–reasonablyforeseeableworstcaseUSESCENARIOS;,,

,"–USERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthoseto",,

,mitigateRISK;,,

,–requirementsfordeterminingwhetherPRIMARYOPERATINGFUNCTIONSareeasily,,

,recognizablebytheUSER.,,

5.6,TheMANUFACTURERshallprepareandmaintainaUSABILITYVALIDATIONplan.TheUSABILITY,,

-62366,VALIDATIONplanshallspecify:,,

,–anymethodusedforVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTIONS;,,

,–thecriteriafordeterminingsuccessfulVALIDATIONoftheUSABILITYofthePRIMARY,,

,OPERATINGFUNCTIONSbasedontheUSABILITYSPECIFICATION;and,,

,–theinvolvementofrepresentativeintendedUSERS.,,

,TheUSABILITYVALIDATIONplanshalladdress:,,

,"–frequentUSESCENARIOS,and",,

,"–reasonablyforeseeableworstcaseUSESCENARIOS,",,

,thatareidentifiedintheUSABILITYSPECIFICATION.,,

5.8,"AspartoftheMEDICALDEVICEdesignVERIFICATIONPROCESS,theMANUFACTURERshallVERIFYtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignagainsttherequirementsoftheUSABILITYSPECIFICATION.TheresultsoftheVERIFICATIONshallberecordedinUSABILITY",,

-62366,ENGINEERINGFILE.,,

5.9,TheMANUFACTURERshallVALIDATEUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan.TheresultsshallberecordedintheUSABILITYENGINEERINGFILE.,,

-62366,,,

6,"Abriefdescriptionofequipment,itsphysicaloperatingprinciples,andsignificantphysicalandperformancecharacteristicsrelevanttoitsusabilityincludedintheinstructionsforuse",,

-62366,,,

,"Accompanyingdocumentsforequipmentare,optionally,providedelectronically,e.g.,byelectronicfileformatorcd-rom:",,

,"Usabilityengineeringprocesshasdeterminedtheinformationthatwillneedt