2025年IEC60601-1-6-Edition-3-检查表-(英文)表格.xlsVIP

IEC60601-1-6

Applies?(yes/no/na)

ReferencetoDocumentation

Clause

Requirement

(60601-1-6)

Equipmentprovidesadequateusability,andtherisksresultingfromnormaluseanduseerrorsareacceptable

4.1.1

TheusabilityPROCESSshalladdressOPERATORinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:

–transport;

–storage;

–installation;

–operation;

–maintenanceandrepair;and

–disposal.

4.1.2

Wheretherequirementsof60601-1-6and62366havebeenapplied,risksassociatedwithusabilityshallbeconsideredacceptableaccordingtoISO14971

4.1.3

Whereinformationforsafetyisusedtocontrolriskstheprocessdefinedin60601-1-6and62366shallbeappliedtothatinformation.

AUsabilityEngineeringProcesscompliantwith62366shallbeappliedusingthefollowingterms:

–Theterm“MEDICALDEVICE”shallassumethesamemeaningasMEEQUIPMENT.

–Theterm“USER”shallassumethesamemeaningasOPERATOR.

–Theterm“PATIENT”shallincludeanimals.

–ThetermSAFETY”shallassumethesamemeaningasBASICSAFETYandESSENTIAL

PERFORMANCE.

–Theterm“USERINTERFACE”shallassumethesamemeaningasOPERATOR-EQUIPMENT

INTERFACE.

–Theterm“USERPROFILE”shallassumethesamemeaningasOPERATORPROFILE.

TheUSABILITYENGINEERINGFILEshall:

–establishedaUSABILITYENGINEERINGPROCESS;

–establishedacceptancecriteriaforUSABILITY;and

–demonstratedthattheacceptancecriteriaforUSABILITYhavebeenmet.

Resultsoftheusabilityengineeringprocessrecordedintheusabilityengineeringfile

TheUsabilityengineeringprocessmaybescaledbasedonthetypeandcomplexityofthedeviceorwheremodificationsarebeingmadetoanexistingdesign.

Riskanalysesshallincorporate/considerthefollowing:

–applicationspecification

–OPERATORPROFILE;

–predictableUSEERRORS

–*taskrelatedrequirements;

–*contextofuse;

–informationonHAZARDSknownforexistingOPERATOR-EQUIPMENTIN