摘要
文章介绍了医疗器械生产洁净区的送排风系统,包括其构成、设计要素以及在监管过程中的检查要点,旨在指导医疗器械生产企业更好的运行其洁净区送排风系统,提高生产质量。
In this paper,clean area and air supply/exhaust system of medical devices production are introduced,including structure,design elements,and inspection points during government supervision.The aim is to guide the medical devices manufacturers better operate the clean area and air supply/exhaust system,as well as improve the quality of production.
作者
甄辉
郑超
杨笑鹤
ZHEN Hui;ZHENG Chao;YANG Xiao-he(Zhejiang Center for Medical Device Evaluation (Zhejiang Hangzhou 310012))
出处
《中国医疗器械信息》
2017年第17期44-46,共3页
China Medical Device Information
基金
浙江省重大软科学研究项目(项目编号:2015C25013)
关键词
医疗器械
洁净区
送排风系统
检查要点
medical devices
clean area
air supply and exhaust system
inspection points
