Historical
ONORM EN 376:2002
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing (FOREIGN STANDARD)
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.
Austrian Standards Institute [on]