Norm

NEN-EN-ISO 23640:2015 en

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

52,53

Over deze norm

Status Definitief
Aantal pagina's 7
Commissie In vitro diagnostica
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-ISO 23640 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. This International Standard can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.

Details

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 - Evaluation of stability of in vitro diagnostic reagents
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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