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摘要This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify,design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIALPERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITYproblems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used toidentify but does not assess or mitigate RISKS associated with ABNORMAL USE.If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been compliedwith and the acceptance criteria documented in the USABILITY VALIDATION plan have been met(see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associatedwith USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVEEVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).