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Publication details

Publication CODE Title
IEC 62366-1:2015 (2015-02) MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
 
Price Excl. VAT Total number of pages, tables and drawings
318.00 € 110 P.
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Replaces  IEC 62366:2007
Replaces  IEC 62366:2007+AMD1:2014 CSV
Replaces  IEC 62366:2007/AMD1:2014
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-02-24
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2015-02-24
IEC stability date 2021-12-31
IEC file modification date 2015-02-23
IEC last modification date 2019-10-31