ISO 23640 In Vitro Diagnostic Medical Devices - Evaluation of Stability of In Vitro Diagnostic Reagents

Medical Device Tests

ISO 23640 In Vitro Diagnostic Medical Devices - Evaluation of Stability of In Vitro Diagnostic Reagents

ISO 23640 is applicable to the stability assessment of in vitro diagnostic medical devices, hereinafter referred to as IVD reagents, including reagents, calibrators, control materials, diluents, buffers and reagent kits. ISO 23640 is also applicable to sample collection devices containing substances used to protect samples or initiate reactions for further processing of the sample in the collecting device.

ISO 23640 In Vitro Diagnostic Medical Devices - Evaluation of Stability of In Vitro Diagnostic Reagents

ISO 23640 specifies general requirements for stability assessment and gives specific requirements for real-time and accelerated stability assessment when generating data in:

  • Determination of IVD reagent shelf life, including appropriate transport conditions, to ensure product specifications are maintained;
  • Ensuring the stability of IVD reagent in use after the first opening of the primary container;
  • Monitoring the stability of IVD reagents currently on the market;
  • Verification of stability specifications after changes to the IVD reagent that may affect stability.

EUROLAB assists manufacturers with ISO 23640 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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