self-testing

examination performed by a layperson to evaluate an individual's health status

Note 1

Typically performed in a home or other environment outside a healthcare institution without supervision by a healthcare professional.

Note 2

Adapted from the definition of “device for self-testing” in Reference [38].

Norm

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.65