制备医用氧的分子筛制氧系统安全有效性研究

Safety and Effectiveness Research of Molecular Sieve Oxygen Generation System that Generate Medical Oxygen

基于目前已注册上市的产品,介绍一种可制备医用氧(氧浓度≥99.5%)的分子筛制氧系统,分析其常见的风险,并立足于注册审评,从技术要求和性能研究、燃爆风险研究、使用稳定性研究、说明书和警示信息四个方面,探讨医用分子筛制氧系统的安全有效性研究。

This paper bases on registered products and introduces a molecular sieve oxygen generation system that generate medical oxygen with a concentration not less than 99.5%.From the perspective of evaluation,this paper analyzes the common risks,and explores the safety and effectiveness of these products focus on four aspects:technical requirements and performance research,explosion risk research,use period research,instructions and warning information.