Please note. This new standard is only a partial replacement to ANSI/AAMI/IEC 62366:2007(R)2013. ANSI/AAMI/IEC 62366:2007(R)2013 is still available, please see historical section. It is expected 62366-2 will be released in late 2015, early 2016.

This document specifies a process for a manufacturer to analyze, 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 mitigates 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.