EN 376:1992

In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing

Scope

This standard specifies requirements for the labelling of in-vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use. The term "self-testing" intends both patient self-testing (i.e. home-testing carried out by patients under the supervision of their physician) and consumer self-testing (i.e. testing carried out by the lay public on their own initiative).