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In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents.

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Overview EN ISO 23640:2015 (identical to ISO 23640:2011) defines requirements for the evaluation of stability of in vitro diagnostic (IVD) reagents. It applies to reagents, calibrators, control mater…

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Overview EN ISO 23640:2015 (identical to ISO 23640:2011) defines requirements for the evaluation of stability of in vitro diagnostic (IVD) reagents. It applies to reagents, calibrators, control mater…

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Overview ISO 23640:2011 - "In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents" - defines requirements for designing, performing and reporting stability eval…