NEN-EN-ISO 23640
In vitro diagnostic medical devices - Stability testing of in vitro diagnostic reagents
inactive
| Organization: | NEN |
| Publication Date: | 1 December 2009 |
| Status: | inactive |
| Page Count: | 21 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This International Standard 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.
Document History
June 1, 2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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...
February 1, 2013
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits,...
December 1, 2011
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits,...
NEN-EN-ISO 23640
December 1, 2009
In vitro diagnostic medical devices - Stability testing of in vitro diagnostic reagents
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits,...