Usability test

Usability tests can be formative, to improve the design, or summative, to validate the final design. Only representative users and realistic conditions give results that count as validation.

method for exploring or evaluating a USER INTERFACE with intended USERS within a specified intended USE ENVIRONMENT

IEC 62366-1:2015+AMD1:2020, clause 3.19

Usability test is defined as a method for exploring or evaluating a user interface with intended users within a specified intended use environment (section 3.19)

MDCG 2021-6 Rev.1, Question 17 (quoting EN 62366-1)