SR EN 376:2003

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 materials and kits, which hereafter are called IVD reagents. NOTE This standard can also be applied to accessories.

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General information

Status : Withdrawn
Approval date : 6/23/2003
Publish date : 6/24/2003
Withdrawal date : 5/31/2010
Number of pages : 18
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 376:1997
Normative reference SR ISO 1000:1995
Replaced by SR EN ISO 18113-4:2010