DS/EN 376:1993
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing

Standard No.

DS/EN 376:1993

Release Date

1993

Published By

Danish Standards Foundation

Status

Withdraw

Latest

DS/EN 376:1993

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" includes 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).

DS/EN 376:1993 history

• 1993 DS/EN 376:1993 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing