Recognition List #46 – Human Factors

In an update to the list of recognized standards (Recognition List #46) FDA-CDRH provides changes to the recognition of international standards on human factors/usability engineering.

IEC 62366 Edition 1.1 2014-01 Consolidated Version Medical devices–Application of usability engineering to medical devices is in transition

IEC 62366-1 Edition 1.0 2015-02 Medical Devices–Part 1: Application of Usability Engineering to Medical Devices [Including CORRIGENDUM 1 (2016)] is withdrawn and replaced with a newer version including corrigendum

The full list is available at

It includes a number of standards not mentioned above.