NEN-EN 376
In-vitro diagnostic systems - Requirements for labelling of in-vitro diagnostic reagents for self-testing
inactive
| Organization: | NEN |
| Publication Date: | 1 July 1994 |
| Status: | inactive |
| Page Count: | 10 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
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)
Document History
March 1, 2002
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
Specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits which are intended for...
November 1, 1999
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
Specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits which are intended for...
NEN-EN 376
July 1, 1994
In-vitro diagnostic systems - Requirements for labelling of in-vitro diagnostic reagents for self-testing
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...