Standard IEC standard · IEC 62366-1:2015

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

Status: Valid · Corrected by: IEC 62366-1:2015/COR1:2016

Scope
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.

Subjects

Medical equipment (11.040) General (11.040.01)


Product information

Language: English French

Written by: IEC

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

Article no: STD-573430

Edition: 1

Approved: 2/24/2015

No of pages: 110

Replaces: IEC 62366:2007 , IEC 62366:2007+AMD1:2014 CSV , IEC 62366:2007/AMD1:2014