Back

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

General information
Valid from 07.05.2015
Base Documents
EN 62366-1:2015; IEC 62366-1:2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.08.2020
Amendment
17.08.2020
Main + amendment
01.08.2018
Corrigendum
05.01.2016
Corrigendum
08.06.2015
Amendment
07.05.2015
Main
07.03.2008
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 correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
*
*
*
PDF
20.50 € incl tax
Paper
20.50 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 02.03.2016
Main

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Newest version Valid from 03.01.2017
Main

EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Withdrawn from 02.01.2020
Amendment

EVS-EN 62304:2006/A1:2015

Medical device software - Software life-cycle processes
Valid from 04.11.2015