NEN-EN 13640:2002 en

Stabiliteitsproeven van in-vitro-diagnostische reagentia

  • Deze norm is ingetrokken sinds 13-12-2011


Over deze norm

Status Ingetrokken
Aantal pagina's 10
Commissie In vitro diagnostica
Gepubliceerd op 01-04-2002
Taal Engels
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 shalf-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.


ICS-code 11.100.10
Nederlandse titel Stabiliteitsproeven van in-vitro-diagnostische reagentia
Engelse titel Stability testing of in vitro diagnostic reagents
Wordt vervangen door
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica



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