Codes & Standards - Purchase
ISO 23640:2011 specifies 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 suitable to ensure that product specifications are maintained;
- the establishment of stability of the IVD reagent in use after the first opening of the primary container;
- the monitoring of stability of IVD reagents already placed on the market;
- the verification of stability specifications after modifications of the IVD reagent that might affect stability.