IEC 62366-1:2015 

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


Do you need a multi-user copy?




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.

Look inside

Additional information

Publication typeInternational Standard
Publication date2015-02-24
Available language(s)English/French
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Stability date  2019
File size1937 KB

Related publications

Share this page

Share your publications

Learn how to share your publications with your colleagues, using networking options.

Payment information

Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa), PayPal and bank transfers as form of payment.

Keep in touch

Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.

Contact customer services

Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 17:00 CET Monday to Friday.