User profile

A user profile is defined for each distinct user group, such as clinicians, patients and service staff. It sets who should take part in usability tests and what the instructions can assume.

summary of the mental, physical and demographic traits of a USER GROUP, as well as characteristics, such as knowledge, skills and abilities, which can have a bearing on design decisions

IEC 62366-1:2015+AMD1:2020, clause 3.29

For the purpose of this document, and also in line with information provided in EN 62366-1:2015/AMD1, the user profile includes ‘the mental, physical or demographic traits of the intended user group, as well as any special characteristics, such as occupational skills, job requirements and working conditions of the user, which can have a bearing on design decisions related to the device’.

MDCG 2023-3 Rev.2, Question 6, footnote 18 (in line with EN 62366-1:2015/AMD1)