体外诊断医疗装置.体外诊断剂的稳定性评估

[中文适用范围]： 本标准适用于体外诊断医疗器械的稳定性评价，包括试剂、校准品、质控品、稀释剂、缓冲液和试剂盒，以下简称IVD试剂。 本国际标准也适用于含有用于保存样品或引发反应以进一步处理收集装置中的样品的物质的样品采集装置。 本国际标准规定了稳定性评价的一般要求，并给出了在生成以下数据时实时和加速稳定性评价的具体要求： ——IVD 试剂保质期的确定，包括适合确保维持产品规格的运输条件； ——首次打开主容器后，建立 IVD 试剂在使用中的稳定性；示例：机载稳定性、重构后稳定性、开瓶稳定性。 监测已投放市场的 IVD 试剂的稳定性； ——对可能影响稳定性的 IVD 试剂进行修改后稳定性规范的验证。 ——本国际标准不适用于仪器、装置、设备、系统或样品容器，或待检验的样品。 [外文原描述]： 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. ISO 23640:2011 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; 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.