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Stability testing of in vitro diagnostic reagents

Executive summary

Stability testing of in vitro diagnostic reagents.

Abstract

This European Standard covers the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. This standard 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.

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