IEC/CD TS 62366-2

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Scope

This Part of IEC 62366, which is a Technical Specification, 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 Specification is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.