Usability (IEC 62366)
Usability, in the context of medical devices, refers to the characteristic of a user interface that enables effective, efficient, and satisfactory use under the intended conditions of use. The harmonised standard IEC 62366-1 describes the usability engineering process aimed at identifying and minimising use errors. The user interface also includes accompanying documents such as instructions for use, whose comprehensibility and clarity directly contribute to safe use.
A translation that is linguistically correct but difficult for the user in the target market to understand impairs usability and can lead to safety-relevant use errors. Professional IFU translation must therefore always keep comprehensibility in focus.
Frequently Asked Questions
Why is usability relevant for IFU translation?+
According to IEC 62366-1, accompanying documents – including instructions for use – must be designed to minimise use errors. This also applies to translated versions: the translation must not only be linguistically correct but also comprehensible and unambiguous for the target users. Cultural and linguistic differences must be considered to ensure usability across all markets.