MEDICAL DEVICES-Part 1: Application of usability engineering to medical devices

基础信息

标准简介

IEC 62366-1:2015.MEDICAL DEVICES -Part 1: Application of usability engineering to medical devices.1 * ScopeThis part of lEC 62366 specifies a PRocEss for a MANUFACTURER to analyse,specify,developand evaluate the usABLITY of a MEDICAL. DEVICE as it relates to SAFETY. This uSABILITYENGINEERING (HUMAN FACTORS ENGINEERING) PROCEss permits the MANUFACTURER to assessand mitigate RIsKs associated with coRRECT uSE and uSE ERRORs, i.e.,NORMAL USE. lt can beused to identify but does not assess or mitigate RISKs associated with ABNORMAL USE.NOTE 1 SAFETY is freedom from unacceptable RISK.Unacceptable RISK can arise from usEERROR, which can leadto exposure to direct physical HAzARDs or loss or degradation of clinical functionality.NOTE 2 Guidance on the application of uSABILITY ENGINEERING to MEDICAL DEVICES is available in lEC 62366-2,which addresses not only SAFETY but also aspects of uSABILITY not related to SAFETY.lf the uSABLLITY ENGINEERING PROCEss detailed in this International Standard has beencomplied with, then the usABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to beacceptable, unless there is oBJECTIVE EVIDENCE to the contrary.NOTE 3 Such oBJECTIVEEVIDENCE can sub

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