In April 2016, the International Electrotechnical Commission (IEC) published IEC/TR 62366-2:2016 Medical Devices, Part 2: Guidance on the Application of Usability Engineering to Medical Devices
As stated in the introduction, “This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their overall medical device development processes. The technical report recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering and seeks to guide the medical device manufacturer’s efforts.”
The technical report includes two normative references.
IEC 62366-1:2015 Medical Devices, Part 1: Application of Usability Engineering to Medical Devices
ISO 14971:2007 Medical Devices, Application of Risk Management to Medical Devices