In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011, IDT)
This Malaysian 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 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.
This Malaysian Standard 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 af
Published
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26/01/2021
16
NSC 18 - Medical Devices and Facilities for Healthcare
