DIN EN 13640:2002-06

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the: determination of IVD shelf-life including transport stability;determination of stability of the IVD reagent in use after the first opening of the primary container;monitoring of stability of IVD reagents already placed on the market.