BS EN ISO 23640:2013 pdf free.In Vitro Diagnostic Medical Devices – Evaluation Of Stability Of In Vitro Diagnostic Reagents.
One important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents is initially designing the stability of a product, then determining and verifying the expiry date of the product that is placed on the market. To determine shelf life, transport stability, and in-use stability, the manufacturer performs an evaluation. In order to provide this important information to the customer, the manufacturer identifies critical factors that might influence stability of the IVD reagent and carefully evaluates these characteristics. Stability of the IVD reagent affects the performance of the device and therefore has an impact on patient results.
It is the manufacturer’s responsibility to determine and monitor stability of IVD reagents to ensure that performance characteristics of the product are maintained. This is best accomplished by developing a stability evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport limitations and in-use stability information, which are then provided to the customers.
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 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; EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.
— 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.
This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.BS EN ISO 23640:2013 pdf free download.