EVS-EN 62366-1:2015/A1:2020

IEC 62366-1 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety.

Since the publication of the main text of IEC 62366-1, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified. A majority of the members of standardisation committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to IEC 62366-1:2015.

To assist the user in implementing the usability engineering process, the technical report IEC TR 62366-2 is available, which contains tutorial information to assist manufacturers in complying with this document, as well as more generally to design medical devices that go beyond safety-related aspects of user interfaces and offer more detailed descriptions of usability engineering methods that can be applied.