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EN 376:1992

In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing EN 376:1992

General information

99.60 Withdrawal effective   Feb 13, 2002

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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).

Life cycle

NOW

WITHDRAWN
EN 376:1992
99.60 Withdrawal effective
Feb 13, 2002

REVISED BY

WITHDRAWN
EN 376:2002