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.