JWG 4 - TC 62/SC 62A/JWG 4

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.

IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.
This publication is to be read in conjunction with IEC 62366-1:2015.

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.