IEC60601-1-6 Edition 3 检查表 (英文)

IEC 60601-1-6 Edition 3 checklist (3rd Edition)Clause4.1RequirementApplies?Reference to Documentation(yes/no/na)Yesuser manualEquipment provides adequate usability, and the risks(60601-1-6)resulting from normal use and use errors are acceptableThe usability PROCESS shall address OPERATOR interactionswith the MEDICAL DEVICE according to the ACCOMPANYING4.1.1DOCUMENT, including, but not limited to:– transport;-62366– storage;– installation;– operation;– maintenance and repair; and– disposal.Where the requirements of 60601-1-6 and 62366 havebeen applied, risks associated with usability shall be-62366considered acceptable according to ISO 14971Where information for safety is used to control risks the4.1.3process defined in 60601-1-6 and 62366 shall be applied to-62366that information.A Usability Engineering Process compliant with 623664.2shall be applied using the following terms:(60601-1-6)– The term “MEDICAL DEVICE” shall assume the samemeaning as ME EQUIPMENT.– The term “USER” shall assume the same meaning as4.1.2OPERATOR.– The term “PATIENT” shall include animals.– The term \"SAFETY” shall assume the same meaning asBASIC SAFETY and ESSENTIALPERFORMANCE.– The term “USER INTERFACE” shall assume the samemeaning as OPERATOR-EQUIPMENTINTERFACE.– The term “USER PROFILE” shall assume the same meaningas OPERATOR PROFILE.The USABILITY ENGINEERING FILE shall:– established a USABILITY ENGINEERING PROCESS;– established acceptance criteria for USABILITY; and– demonstrated that the acceptance criteria for USABILITYhave been met.Results of the usability engineering process recorded in theusability engineering fileThe Usability engineering process may be scaled based onthe type and complexity of the device or wheremodifications are being made to an existing design.Risk analyses shall incorporate/consider the following:– application specification– OPERATOR PROFILE;– predictable USE ERRORS4.2– * task related requirements;– * context of use;– information on HAZARDS known for existing OPERATOR-EQUIPMENT INTERFACES for ME EQUIPMENT of a similar type– results of the review of the OPERATOR-EQUIPMENTINTERFACE4.2-623664.3-62366IEC 60601-1-6 Edition 3 checklist (3rd Edition)ClauseRequirementApplies?Reference to Documentation(yes/no/na)If provided, the instructions for use shall include a briefdescription of the ME EQUIPMENT, its physical operating5principles and significant physical and performancecharacteristics relevant to its USABILITY. The sameinformation shall also be included in the technical(60601-1-6)description, if this is provided as a separate document.Application of the equipment is specified in the usability5.1engineering file, and the specifications include the-62366following information:– medical purpose such as conditions(s) or disease(s) tobe screened, monitored, treated, or diagnosed :– patient population such as age, weight, region of body,health, and condition :– part of the body or type of tissue applied to or interactedwith :– intended OPERATOR profile :– application such as environment, frequency of use,location, and mobility :The MANUFACTURER shall determine the frequently used5.2functions that involve USER interaction with the MEDICAL DEVICE-62366and record them in the USABILITY ENGINEERING FILEAn identification of characteristics related to SAFETY (part of aRISK ANALYSIS) that focuses on USABILITY shall be performed5.3.1according to ISO 14971:2007, 4.2. These shall consider at– application specification, including USER PROFILE(S); and-62366– frequently used functionsThe results of this identification characteristics related toSAFETY shall be recorded in the USABILITY ENGINEERING FILE.The MANUFACTURER shall identify known or foreseeableHAZARDS (part of a RISK ANALYSIS) to PATIENTS, USERS andreasonably foreseeable sequences or combinations of eventsinvolving the USER INTERFACE that can result in a HAZARDOUSSITUATION. The SEVERITY of the resulting possible HARM shallbe determined and documented as part of the risk analysis andin the USABILITY ENGINEERING FILE.During the identification of HAZARDS and HAZARDOUSSITUATIONS, the following shall beconsidered:– application specification, including USER PROFILE(S)–task related requirements;–context of use;– information on HAZARDS and HAZARDOUS SITUATIONS knownfor existing USER INTERFACES ofMEDICAL DEVICES of a similar type, if available;– preliminary USE SCENARIOS;– possible USE ERRORS– if an incorrect mental model of the operation of the MEDICALDEVICE can cause a USE ERROR resulting in a HAZARDOUSSITUATION; and– results of the review of the USER INTERFACEThe MANUFACTURER shall determine the PRIMARYOPERATING FUNCTIONS and record them in the USABILITYENGINEERING FILE.The inputs to the PRIMARY OPERATING FUNCTIONSidentification shall include the following:5.3.2-623665.4-62366IEC 60601-1-6 Edition 3 checklist (3rd Edition)ClauseRequirement– frequently used functions and– functions related to SAFETY of the MEDICAL DEVICE.The MANUFACTURER shall develop the USABILITYSPECIFICATION. The USABILITY SPECIFICATION shall provide:– testable requirements for USABILITY VERIFICATION; and– testable requirements for USABILITY of the PRIMARYOPERATING FUNCTIONS including criteria for determining theadequacy of RISK CONTROL achieved by the USABILITYPROCESS.Applies?Reference to Documentation(yes/no/na)5.5-62366The inputs to the USABILITY SPECIFICATION shall include thefollowing:– application specification– PRIMARY OPERATING FUNCTIONS– HAZARDS and HAZARDOUS SITUATIONS related to USABILITY;and– known or foreseeable USE ERRORS associated with theMEDICAL DEVICE.The USABILITY SPECIFICATION shall describe at least:– USE SCENARIOS related to the PRIMARY OPERATINGFUNCTIONS, including;– frequent USE SCENARIOS; and– reasonably foreseeable worst case USE SCENARIOS;– USER INTERFACE requirements for the PRIMARY OPERATINGFUNCTIONS, including those tomitigate RISK;– requirements for determining whether PRIMARY OPERATINGFUNCTIONS are easilyrecognizable by the USER.The MANUFACTURER shall prepare and maintain a USABILITYVALIDATION plan. The USABILITYVALIDATION plan shall specify:– any method used for VALIDATION of the USABILITY of thePRIMARY OPERATING FUNCTIONS;5.6-62366– the criteria for determining successful VALIDATION of theUSABILITY of the PRIMARYOPERATING FUNCTIONS based on the USABILITY SPECIFICATION;and– the involvement of representative intended USERS.The USABILITY VALIDATION plan shall address:– frequent USE SCENARIOS, and– reasonably foreseeable worst case USE SCENARIOS,that are identified in the USABILITY SPECIFICATION.As part of the MEDICAL DEVICE design VERIFICATION PROCESS,the MANUFACTURER shall VERIFY the implementation of theMEDICAL DEVICE USER INTERFACE design against therequirements of the USABILITY SPECIFICATION. The results ofthe VERIFICATION shall be recorded in USABILITYENGINEERING FILE.5.8-623665.9-623666The MANUFACTURER shall VALIDATE USABILITY of the MEDICALDEVICE according to the USABILITY VALIDATION plan. The resultsshall be recorded in the USABILITY ENGINEERING FILE.A brief description of equipment, its physical operatingprinciples, and significant physical and performancecharacteristics relevant to its usability included in theinstructions for use

IEC 60601-1-6 Edition 3 checklist (3rd Edition)Clause-62366Applies?principles, and significant physical and performanceRequirementReference to Documentation(yes/no/na)characteristics relevant to its usability included in theinstructions for useAccompanying documents for equipment are, optionally,provided electronically, e.g., by electronic file format or cd-Usability engineering process has determined theinformation that will need to be provided as a hard copy oras markings on equipment (e.g., to cover emergencyoperation) when Accompanying documents are providedAccompanying documents include a description of theoperator profileAccompanying documents are written at a level consistentwith the intended operator profileNecessary training materials provided in the instructionsfor use when equipment specific training is required forprimary operating functions of equipment;– instructions for use indicate and ensure training materialsare available; or– the manufacturer provides trainingThe ACCOMPANYING DOCUMENTs shall describe the availabletraining options and should include the suggested duration andfrequency of such trainingIntended use/intended purpose and operator profile is thebasis for training and training material7-62366