Use environment

Lighting, noise, distractions, gloves and time pressure all belong to the use environment. Human factors testing should recreate the conditions that matter, and a device moving from hospital to home use faces a new environment that needs its own evaluation.

actual conditions and setting in which USERS interact with the MEDICAL DEVICE Note 1 to entry: The conditions of use or attributes of the USE ENVIRONMENT can include hygienic requirements, frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization. Social attributes such as team versus individual, chaotic versus calm, stress level and length of shift can also play a role.

IEC 62366-1:2015+AMD1:2020, clause 3.20

Actual conditions and setting in which users interact with the IVDs (e.g. self-tests).

MDCG 2022-2, Section 4, Definitions (modified from 62366-1:2015)

Use environment is actual conditions and setting in which users interact with the medical device (section 3.20)

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

Actual conditions and setting in which users interact with the medical device.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions