无菌医疗器械生产环境表面微生物监测论述  

Monitoring of Surface Microorganisms in the Production Environment of Sterile Medical Devices

作　　者：徐中和 张广 王锡彬 XU Zhonghe;ZHANG Guang;WANG Xibin(Shandong Weigao Group Medical Polymer Products Company Limited,Weihai 264210,China)

机构地区：[1]山东威高集团医用高分子制品股份有限公司,山东威海264210

出　　处：《工业微生物》2024年第4期135-137,共3页Industrial Microbiology

摘　　要：GB15980-1995《一次性使用医疗用品卫生标准》的作废,意味着我国当前缺乏关于医疗器械生产环境表面微生物监控的参考标准,且没有明确法规条款的规定,容易导致表面微生物给医疗器械造成最直接的微生物污染。文章依据药品生产质量管理规范(2010年修订)附录1无菌药品和GB 15979-2002《一次性使用卫生用品卫生标准》的相关规定,对无菌医疗器械生产环境表面微生物标准制定的重要性及监测注意事项展开了分析和论述。With the abolition of GB 15980-1995 Sanitary Standards for Single-use Medical Supplies,there is a lack of reference standards for monitoring surface microorganisms in the production environment of medical devices,and there is no clear regulatory provisions.Surface microorganisms can cause the most direct microbial contamination to medical devices.This paper analyses and discusses the importance of the development of surface microbiological standards for the production environment of sterile medical devices and the monitoring considerations according to the Appendix 1 of the Good Manufacturing Practice for Drugs(revised in 2010),Sterile Drugs,and the relevant provisions of GB 15979-2002 Hygienic Standard for Disposable Sanitary Articles.

关 键 词：无菌医疗器械 洁净区 表面微生物 

分 类 号：TH77[机械工程—仪器科学与技术]