What is ISO 23640 - Stability of in vitro diagnostic reagents about?
ISO 23640 is a European standard that discusses In vitro diagnostic medical devices that discuss the evaluation of the stability of in vitro diagnostic reagents. ISO 23640 applies to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers, and reagent kits, hereinafter called IVD reagents.
ISO 23640 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.
ISO 23640 outlines 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 the stability of IVD reagents already placed on the market
- The verification of stability specifications after modifications of the IVD reagent that might affect the stability
Note: ISO 23640 does not apply to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.
Who is ISO 23640 - Stability of in vitro diagnostic reagents for?
ISO 23640 on the stability of in vitro diagnostic reagents is useful for:
- Medical laboratories
- In vitro diagnostic centres
- Regulatory authorities
Why should you use ISO 23640- 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. Accelerated stability evaluation is a study designed to increase the rate of chemical and/or physical degradation, or change, of an IVD reagent by using stress environmental conditions to predict shelf life.
ISO 23640 guideline assists you with general requirements, protocol, stability reports, procedures, real-time stability evaluation, and accelerated stability evaluation for the evaluation of the stability of in vitro diagnostic reagents.
With compliance and obedience to ISO 23640, you can efficiently evaluate the characteristics and stability of in vitro diagnostic reagents.