Implications for Medical Device Usability Engineering following amendments to IEC 62366

International Standard IEC 62366-1: Application of usability engineering to medical devices, was updated and published in June 2020. There are several changes, some small and some more significant; with all key changes affecting usability engineering.

Key changes include:

  • Reference to risk management: Reference to the 2019 version of ISO 14971.
  • Definition 3.22: Use scenario: the term “critical task” has been introduced as a use error could lead to significant harm.
  • Definition 3.25: User group: the definition has been rewritten to say that the subsets of users are differentiated by “factors that are likely to influence their interactions with the medical device”.
  • Types of use: This is mapped to correspond with the scope of ISO 14971 and to show how both standards should be applied. The following types of use are represented:
    • Reasonably foreseeable use
    • Not reasonably foreseeable use
    • Abnormal use (being outside of the scope of IEC 62366)
  • Risk control measures 4.1.2: training as a third priority control measure is introduced in addition to information of safety.
  • Summative evaluation5.7.3: new requirements include:
    • Explicitly state how the participants are representative of the intended user profiles
    • Describe how the test environment and conditions are representative of the intended use environment
    • Define correct use for each hazard-related use scenario
    • Describe how data will be collected during the test.
  • Summative evaluation acceptance criteria 5.7.3: This has been removed and replaced with a explanation that the purpose of the summative evaluation is to obtain objective evidence that the residual use-related risk is acceptable.
  • Action errors: has a new definition name of “physical mismatch” (i.e. the definition of both is the same)

Further information can be found here.