This International 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 International 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 International Standard specifes general requirements for stability evaluation and gives specifc 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 specifcations are maintained;
- the establishment of stability of the IVD reagent in use after the frst opening of the primary container;
EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.
- the monitoring of stability of IVD reagents already placed on the market;
- the verifcation of stability specifcations after modifcations of the IVD reagent that might affect stability.
This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.