无菌医疗器械包装生物负载对产品的影响  

Impact of Sterile Medical Device Package Bioburden on Products

作　　者：李梦媛[1] 沈以凌[1] 张悦[1] 李浩鹏[1] Li Mengyuan;Shen Yiling;Zhang;Yue Li Haopeng(Beijing Research Center for Radiation Application)

机构地区：[1]北京市射线应用研究中心

出　　处：《塑料包装》2019年第2期27-28,9,共3页Plastics Packaging

摘　　要：无菌医疗器械包装是无菌医疗器械的重要组成部分,为无菌医疗器械提供了有效的保护。在设定无菌医疗器械灭菌参数和日常质量控制时,生物负载是重要的参考依据。该文对某无菌医疗器械包装生物负载及产品生物负载分别进行监控,浅谈无菌医疗器械包装生物负载对产品的重要性。Sterile medical device package is an important part of sterile medical devices.It provides protection for sterile medical devices. Bioburden is an important reference in setting sterilization parameters and daily quality control of sterile medical devices.The study tests the bioburden of the sterile medical device package and the bioburden of the product separately.Discuss the importance of sterile medical device packaging bioburden to the product.

关 键 词：医疗器械 包装 生物负载 

分 类 号：TH77[机械工程—仪器科学与技术]