Standard

IEC 62366:2007 ED1

Oct 2007 Replaced

Note: This standard has a new edition: IEC 62366:2007+AMD1:2014 CSV

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Amendment 1 - Medical devices - Application of usability engineering to medical devices Replaced IEC 62366:2007/AMD1:2014 ED1 Amendment from Publication date: Jan 2014 Version: 1 Pages: 13 Language: English/French Services: Read Online (No printing ), Printed and bound

Abstract

Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems 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. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.

Document information

Standard from IEC
Published: 18 October 2007
Withdrawn: 27 April 2016
Edition: 1
Version: 1
Document type: IS
Pages
ISBN: 2831893135

ICS 11.040.01
ISO TC TC 62/SC 62A

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Replaced by: IEC 62366-1:2015+AMD1:2020 CSV
Replaced by: IEC 62366-1:2015 ED1

IEC 62366:2007 ED1

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IEC 62366:2007+AMD1:2014 CSV