DS/EN 376
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
inactive
| Organization: | DS |
| Publication Date: | 22 September 1992 |
| Status: | inactive |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
The 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 initiatives).
Document History
May 13, 2002
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control...
DS/EN 376
September 22, 1992
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
The 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...
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