摘要
医用分子筛制氧机因其制氧成本低、风险低、供氧连续性好、制氧效率高等特点,已成为主流制氧方式。文章以技术审评的视角,介绍产品结构组成、主要危险源、性能指标、使用注意事项、研究重点内容等,以期为分子筛制氧机行业注册申请人的注册申报及上市后监管提供依据。
Medical molecular sieve oxygen generator has become the mainstream oxygen production method because of its low oxygen production cost,low risk,good oxygen supply continuity and high oxygen production efficiency.From the perspective of technical review,this paper introduces product structure,main hazard sources,performance indexes,precautions for use,and key research contents,in order to provide a basis for the registration of molecular sieve oxygen generator industry registration applicants and post-listing supervision.
作者
任希力
徐琨
李国勇
夏文龙
REN Xi-li;XU Kun;LI Guo-yong;XIA Wen-long(Shandong Center for Food and Drug Evaluation&Inspection,Shandong Jinan 250014)
出处
《中国医疗器械信息》
2024年第3期18-21,共4页
China Medical Device Information
关键词
分子筛
变压吸附
富氧空气
molecular sieve
pressure swing adsorption
oxygen-rich air
