Comparison of IEC 62366-1:2015 and IEC 62366:2007+AMD1:2014 - The Major Differences

The publication of the internationally harmonized usability standards IEC 62366-1:20151 and IEC TR 62366-2:20162 replaces the prior edition of the usability standard, IEC 62366:2007+AMD1:20143. The new IEC 62366-1 describes a contemporary usability engineering process that is somewhat streamlined compared to the previously prescribed one.

The new standard strengthens links to ISO 14971:20074 and the risk management methods related to safety-related aspects of medical device user interfaces. While we are unable to share direct excerpts of the documents due to copyright limitations, the following provides a clause by clause explanation of the changes.