SR EN 375:2003

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.

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General information

Status : Withdrawn
Approval date : 6/24/2003
Publish date : 6/25/2003
Withdrawal date : 5/31/2010
Number of pages : 20
ICS : 01.040.11 Health care technology (Vocabularies),11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 375:1997
Normative reference SR ISO 1000:1995
Replaced by SR EN ISO 18113-2:2010