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IEC 62366-1:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices - Part 1: Application of usability engineering to medical devices
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

06-20-2020

Published date

02-24-2015

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 (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.

Committee
TC 62/SC 62A
DevelopmentNote
NEW CHILD AMD 1 IS ADDED NOW
DocumentType
Standard
Pages
148
ProductNote
NEW CHILD AMD 1 IS ADDED NOW
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy
Supersedes

ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
CEI EN IEC 61010-2-101:2023 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide

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