湖北省部分医疗器械生产企业工艺用水水质状况调查  

Investigation on the Quality of Process Water for Some Medical Device Manufacturing Enterprises in Hubei Province

作　　者：梅享林 魏嫣 MEI Xiang-lin;WEI Yan(Hubei Medical Devices Quality Supervision and Test Institute,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2021年第11期15-17,共3页China Medical Device Information

摘　　要：目的:掌握湖北省内医疗器械生产企业工艺用水水质状况。方法:依据相关标准对湖北省内31家医疗器械生产企业的34批次生产工艺用水理化指标进行抽检并查看企业工艺用水管理情况。结果:共有6家生产企业的工艺用水超过参考限值,不合格的主要问题主要集中在电导率、易氧化物和酸碱度等三个项目。结论:本省生产企业的工艺用水存在一定的问题,企业应加强对工艺用水的管理。Objective:To master the process water quality of medical device manufacturing enterprises in hubei province.Methods:According to the relevant standards,34 batches of process water physical-chemical indexs of 31 medical device manufacturing enterprises in hubei province were randomly checked and their process water management was checked.Results:The results of 6 batches of process water were exceeded the reference limits,The main failure items focus on conductivity,readily oxidizablesubstanc and phvalue.Conclusion:There are some problems with the process water of the medical device manufacturing enterprises in hubei province,enterprises should strengthen the management of the process water use.

关 键 词：医疗器械 工艺用水 纯化水 

分 类 号：R197.39[医药卫生—卫生事业管理]