医用分子筛制氧设备质量控制要点及对策分析  

Quality Control Key Points and Countermeasures of Medical Molecular Sieve Oxygen Generators

作　　者：李国勇 肖杰 任希力 杨阳 马素华 夏文龙 LI Guoyong;XIAO Jie;REN Xili;YANG Yang;MA Suhua;XIA Wenlong(Shandong Center for Food and Drug Evaluation&Inspection,Jinan Shandong 250014,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《中国医疗设备》2023年第10期14-19,共6页China Medical Devices

基　　金：国家自然科学基金(82172543)。

摘　　要：医用氧气是重症呼吸系统疾病患者的重要治疗手段。分子筛变压吸附制氧具有简单方便、成本低、耗能少、易于调控等特点,已成为临床用氧的重要制备方式。但在临床使用中部分产品存在氧浓度过低、杂质含量过高、输出流量不稳定等问题,给临床应用带来很大隐患。本文基于产品安全、有效的基本要求,围绕产品质量控制中的主要关注点,如氧浓度、氧气洁净度、水分含量、氧流量稳定性、高海拔下性能、家用要求、电气安全性等,开展详细阐述及分析,以期为该产品的设计生产、注册审批、日常监管提供参考。Medical oxygen is an important treatment for respiratory diseases such as severe novel coronavirus patients.Molecular sieve pressure swing adsorption oxygen production method is simple and convenient,low cost,less energy consumption,easy to control and so on,has become an important preparation method of clinical oxygen.However,in the clinical use of some molecular sieve equipment,oxygen concentration is too low,the content of impurities is too high,and the output flow is unstable,which brings great risks to the clinical application.Based on the basic requirements of product safety and effectiveness,this paper aims to elaborate and analyze the main concerns in product quality control,such as oxygen concentration,oxygen cleanliness,moisture content,oxygen flow stability,performance at high altitude,and safety requirements to provide reference for the design and production,registration and approval,daily supervision of the product.

关 键 词：医用制氧设备 变压吸附 质量控制 要点分析 医用氧气 

分 类 号：R197.39[医药卫生—卫生事业管理]