BS EN ISO 23640:2015适用于体外诊断医疗设备的稳定性评估，包括 试剂、校准器、对照材料、稀释剂、缓冲液和试剂盒，以下简称IVD试剂。这 国际标准也可适用于含有用于检测的物质的样本采集装置 保存样品或启动反应，以便在采集设备中进一步处理样品。本国际标准规定了稳定性评估的一般要求，并给出了具体说明 生成数据时的实时和加速稳定性评估要求:建立IVD试剂保质期，包括适合确保产品质量的运输条件 保持规范；第一次打开主容器后，确定使用中IVD试剂的稳定性；船上稳定性、重组后稳定性、开瓶/瓶稳定性示例。监测已投放市场的IVD试剂的稳定性；可能影响稳定性的IVD试剂修改后的稳定性规范验证。本国际标准不适用于仪器、仪器、设备、系统或样品 容器或接受检查的样品。交叉引用:ISO 1497198/79/ECISO 18113-1:2009EN 13640CLSI EP25 A购买本文件时可获得的所有现行修订版均包含在购买本文件中。

BS EN ISO 23640:2015 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. This International Standard 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.This International Standard 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;EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.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.This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.Cross References:ISO 1497198/79/ECISO 18113-1:2009EN 13640CLSI EP25-AAll current amendments available at time of purchase are included with the purchase of this document.