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 reagent shelf-life including transport stability;
determination of stability of the IVD reagent in use after the first opening of the primary container
(e. g. on-board stability);
monitoring of stability of IVD reagents already placed on the market;
verification of stability after IVD reagent modifications that may affect stability.
This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.
Diese ÖNORM gilt für die Stabilitätsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen, einschließlich Reagenzprodukten, Kalibratoren, Kontrollmaterialien und Kits.