ISO 23640:2011适用于体外诊断医疗器械的稳定性评估，包括试剂，校准品，对照物质，稀释剂，缓冲液和试剂盒，以下称为IVD试剂。 ISO 23640:2011也可以应用于含有用于保存样品的物质的样品采集装置或者用于在采集装置中进一步处理样品的反应。 ISO 23640:2011规定了稳定性评估的一般要求，并在生成数据时给出了实时和加速稳定性评估的具体要求: 建立IVD试剂保质期，包括运输条件适合确保产品规格的维护; 在首次开启主容器之后建立使用中的IVD试剂的稳定性; 对已经投放市场的IVD试剂的稳定性进行监测; 验证可能影响稳定性的IVD试剂修改后的稳定性规格

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.