ISO 23640:2011适用于体外诊断医疗器械的稳定性评价，包括试剂、校准品、对照材料、稀释剂、缓冲液和试剂盒，以下称为IVD试剂。ISO 23640:2011也可应用于含有用于保存样品或引发反应以在收集装置中进一步处理样品的物质的样本收集装置。 ISO 23640:2011规定了稳定性评价的一般要求，并给出了在以下方面生成数据时实时和加速稳定性评价的具体要求: 建立IVD试剂保质期，包括适合确保保持产品规格的运输条件； 在第一次打开主容器之后建立IVD试剂在使用中的稳定性；已上市IVD试剂的稳定性监测； 在可能影响稳定性的IVD试剂修改后验证稳定性质量标准。

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.