This standard is applicable to the stability evaluation of in vitro diagnostic medical devices, so-called in vitro diagnostic reagents, including reagents, calibrators, standards, diluents, buffers and reagent kits. This standard is applicable to sample collection equipment containing substances used to preserve samples or to initiate reactions for further processing of samples. This standard sets out general requirements for stability assessment when: Places special requirements for real-time and accelerated stability assessments when generating data from:
——Establishing an in vitro diagnostic reagent shelf life, including transportation conditions suitable to ensure maintenance of product specifications - In vitro diagnostic reagent shelf life after opening of the primary container. Establishing stability Stability during transport, stability after product reconstitution, stability of reagent containers after opening - Monitoring the stability of in vitro diagnostic reagents already on the market - Verification of stability specifications after modifications of in vitro diagnostic reagents that may affect stability This standard is It cannot be applied to equipment, instruments, devices, systems, or sample containers or test samples.
KS P ISO 23640:2013 history
2019KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
2013KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents