NF EN ISO 23640

<p>ISO 23640:2011 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. ISO 23640:2011 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. </p> <p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:</p> <ul> <li> the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; </li> <li> the establishment of stability of the IVD reagent in use after the first opening of the primary container;</li> <li> the monitoring of stability of IVD reagents already placed on the market;</li> <li> the verification of stability specifications after modifications of the IVD reagent that might affect stability.</li> </ul>

<p>ISO 23640:2011 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. ISO 23640:2011 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. </p> <p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:</p> <ul> <li> the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; </li> <li> the establishment of stability of the IVD reagent in use after the first opening of the primary container;</li> <li> the monitoring of stability of IVD reagents already placed on the market;</li> <li> the verification of stability specifications after modifications of the IVD reagent that might affect stability.</li> </ul>