Several amendments to the text of the international standard IEC 62366-1: Application of usability engineering to medical devices have been published in June 2020. This standard drives much of the usability engineering work done by Emergo by UL’s Human Factors Research & Design (HFR&D) team. There are a large number of changes, some small and some more significant. The key changes that will affect usability engineering (UE) methods are as follows:
Key changes to IEC 62366
Reference to risk management: Updating of the reference to ISO 14971 with the standard’s 2019 version. So in effect, this means that manufacturers should follow the 2019 version of ISO 14971.
Definition 3.22: Use scenario: Introduction of the term “critical task” as one for which a use error could lead to significant harm (i.e., aligning with US FDA use of the term “critical task”). Note that this term has not been included in IEC 62366’s formal list of definitions. But, it is an important inclusion nonetheless…