Back

IEC 62366-1:2015+AMD1:2020 CSV

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

General information
Valid from 17.06.2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
IEC 62366-1:2015+A1:2020 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 (not published yet), 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, once published, will contain 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. The contents of the corrigendum of July 2016 have been included in this copy. This consolidated version consists of the first edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication.
*
*
*
PDF
552.23 € 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 11608-1:2015

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
Newest version Valid from 04.02.2015
Main

ISO 8871-1:2003

Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
Newest version Valid from 19.09.2003
Main

ISO 11040-4:2015

Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Newest version Valid from 02.04.2015