RO
SR EN 376:1997
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" 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).
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Status :
Withdrawn
Approval date : 12/11/1996
Publish date : 12/12/1996
Withdrawal date : 6/23/2003
Number of pages : 12
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices
- Replaced by SR EN 376:2003