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EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)

General information
Valid from 17.08.2020
Base Documents
EN 62366-1:2015; IEC 62366-1:2015; EN 62366-1:2015/AC:2015; IEC 62366-1:2015/COR1:2016; EN 62366-1:2015/AC:2016-09; IEC 62366-1:2015/A1:2020; EN 62366-1:2015/A1:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.08.2020
Main + amendment
17.08.2020
Amendment
01.08.2018
Corrigendum
05.01.2016
Corrigendum
07.05.2015
Main
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. It can be used 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 use error, which can lead to exposure to hazards including loss or degradation of clinical performance. NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
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