我国医用氧气及分子筛制氧设备监管要求和对策

本文分析我国医用制氧设备及氧气制造原理、管理分类、质量标准、生产要求，依据国家相关法规探索其分类监管及临床应用中存在的难点和不足，以加强医疗机构分子筛制氧设备、医用氧及临床用氧的管理。分子筛制氧设备按医疗器械管理，新修订的《医用气体管道系统用氧气浓缩器供气系统》标准规定其产出气体应符合国家有关法规规定。我国已针对该设备产出气——富氧空气发布了国家药品标准，但如何按药品管理富氧空气尚无明确的规定。依据设备运行、维护、监控等影响生产富氧空气质量的因素，提出富氧空气按医疗机构制剂管理的建议。

Requirements of supervision and suggestions for medical oxygen and oxygen concentrator in China

This article analyses demands of supervision for medical oxygen and oxygen concentrator based on the relative documents of the government, and the principle, classification, manufacturing, quality specification, and discovered on difficulties and problems of oxygen and molecular sieve device in situations of supervision and using in medicine institutes. It is required to comply with regulations of states according to ＂Oxygen concentrator supply systems for use with medical gas pipe line systems＂ for oxygen-enriched air produced by oxygen concentrator, a medical device, moreover the national drug standard of oxygen-enriched air had issued. But there is no provision of supervision published. It is suggested that classified as a medicinal preparation for oxygen-enriched air by the influence factors of the quality, such as operating, maintaining and controlling of an oxygen concentrator.