Back

IEC 62366-1:2015

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

General information
Valid from 24.02.2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.06.2020
Amendment
14.07.2016
Corrigendum
24.02.2015
Main
13.11.2007
Main
IEC 62366-1:2015 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.
*
*
*
PDF
309.25 € incl tax
Paper
309.25 € incl tax
Standard monitoring
Customers who bought this item also bought
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Withdrawn from 02.01.2020
Main

ISO 13485:2016

Medical devices -- Quality management systems -- Requirements for regulatory purposes
Newest version Valid from 25.02.2016
Main

IEC TR 62366-2:2016

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
Newest version Valid from 27.04.2016
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