Last month, the IEC (International Electrotechnical Commission) published IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices (purchase here or here). As noted in the Forward:
This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). (p. 4)
IEC/TR 62366-2, Medical devices – Part 2: Guidance on the Application of Usability Engineering to Medical Devices, is still in draft form and should be published in 2016. The Forward further explains the difference between -1 and -2 by stating:
Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE USER INTERFACES. (pp. 4-5)
I first learned about the standard being divided into two parts from a presentation (.pdf) Ed Israelski, PhD gave at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap.
I’ll post a more in-depth review of the standard after I’ve had some time to fully digest it.