Skip to main content
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
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.

Required fields are indicated with *

*
*
*
PDF
393.34 € incl tax
Paper
393.34 € 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Withdrawn from 02.01.2020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

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)
Withdrawn from 01.10.2021
Main

ISO 15223-1:2016

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)
Withdrawn from 06.07.2021
Amendment

EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 16.09.2021