医用氧质量标准修订及执行情况介绍  

Introduction to the revision and implementation of the medical oxygen quality standard

作　　者：李雪[1] 李佩 洪建文[1] LI Xue;LI Pei;HONG Jianwen(Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国药品标准》2023年第5期508-512,共5页Drug Standards of China

摘　　要：新修订的医用氧质量标准自2022年5月正式实施(批件号:XGB2021-061),修订标准较原标准在检测项目和方法上都有较大变化,增加了水分检查,删除了酸碱度和其他气态氧化物质检查项,修订了一氧化碳、二氧化碳和氧含量测定方法。本文从国内外标准收载情况、起草背景、标准变化情况以及执行过程中的问题方面进行逐一分析介绍,帮助医用氧的生产企业、使用单位及监管部门更好地理解和执行新修订标准。The newly revised medical oxygen quality standard has been officially implemented since May 2022(Approval No:XGB2021-061).The revised standard has changed a lot from the original standard,including the addition of water vapour test,the deletion of the inspection items of pH and other gaseous oxidizing substances,and the revision of the determination methods of carbon monoxide,carbon dioxide and oxygen content.This article introduced the collection of domestic and foreign standards,drafting background,quality standard changes and problems in the implementation process one by one in order to help medical oxygen manufacturers,users and regulatory authorities better understand and implement the new revised standards.

关 键 词：氧 气体检测管 红外分析仪 电解湿度计 顺磁式氧分析仪 

分 类 号：R921.2[医药卫生—药学]