NEN-EN-ISO 23640:2009 Ontw. en

In-vitro-diagnostische medische systemen - Stabiliteitsproeven van in-vitro-diagnostische reagentia

  • Deze norm is ingetrokken sinds 13-12-2011


Over deze norm

Status Ingetrokken
Aantal pagina's 15
Commissie In vitro diagnostica
Gepubliceerd op 01-12-2009
Taal Engels
This International Standard is applicable to the stability testing of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits., hereinafter called IVD reagents. It can also be applied to specimen collection devices that contain substances used to preserve specimens or to initiate reactions for further processing of the specimen in the collection device. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating data in the - establishment of IVD reagent shelf-life; - transport conditions suitable to ensure product specifications are maintained; - establishment of stability of the IVD reagent in use after the first opening of the primary container; EXAMPLES on-board stability, after reconstitution, open vial/bottle stability; - monitoring of stability of IVD reagents already placed on the market; - verification of stability specifications after modifications to the IVD reagent that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles, or the material subject to examination.


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



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