无菌医疗器械生产用水制备与检测监管研究  

作　　者：匡萌 尹冬丽 

机构地区：[1]华仁药业股份有限公司,山东青岛266101

出　　处：《科技创新与应用》2020年第17期195-196,共2页Technology Innovation and Application

摘　　要：无菌医疗器械实际生产的进程中,多个环节都涉及到用水,如果不能确保生产用水制备与检测的工作效果,将会对无菌医疗器械生产的安全性造成影响,出现化学污染与微生物污染等问题。因此,在无菌医疗器械生产用水制备与检测的工作中,应强化监管力度,通过有效的监管方式,规范生产用水的制备行为与检测行为,为生产出安全性、高质量的无菌医疗器材提供保障。In the process of the actual production of aseptic medical devices, many links involve the use of water. If we can not ensure the working effect of the preparation and detection of production water, it will affect the safety of the production of aseptic medical devices. There are some problems, such as chemical pollution and microbial pollution. Therefore, in the preparation and detection of water for the production of aseptic medical devices, supervision should be strengthened, and the preparation and detection behavior of production water should be standardized through effective supervision so as to provide guarantee for the production of safe and high-quality aseptic medical devices.

关 键 词：无菌医疗器械 生产用水 制备与检测 监管措施 

分 类 号：TH77[机械工程—仪器科学与技术]