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DIN EN ISO 23640:2012
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011 (Foreign Standard)
This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits.*This 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. It specifies the general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in - the establishment of IVD reagent shelf life, including transport conditions; - the establishment of stability after the first opening of the primary container and - the monitoring of stability of IVD reagents already placed on the market.
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Deutsches Institut für Normung [din]