医疗器械细菌内毒素常规监控/跳批检验用产品单元选择方案研究

Discussion on Product Unit Selection for Routine Control/Skip Batch Test of Bacterial Endotoxin in Medical Devices

依据《医疗器械细菌内毒素试验方法常规监控与跳批检验》(YY/T 0618—2017)中关于细菌内毒素产品单元选择的要求,设计出符合标准要求的代表性样品抽样方案,用于成品常规监控/跳批检验,旨在减少重复检验,优化检验程序。

According to the requirements of Test Methods for Bacterial Endotoxins of Medical Devices: Routine Monitoring and Alternatives to Batch Testing(YY/T 0618—2017) on the selection of bacterial endotoxin product units,this paper designs a representative sample sampling scheme that meets the standard requirements for routine monitoring/skip batch inspection of finished products, in order to reduce repeated inspection and optimize inspection progress.