透析用水国际标准的理解与探讨  

Understanding and discussion of the international standard of dialysis water

作　　者：罗丽华 叶晓燕 王升升 杨正根 唐友洪 张乐宇 LUO Li-hua;YE Xiaoyan;WANG Sheng-sheng;YANG Zheng-gen;TANG You-hong;ZHANG Le-yu(Guangzhou Kangsheng BioScience Co.,LTD.,Guangzhou 510660,China;Guangzhou Vocational College of Technology&Business,Guangzhou 511442,China)

机构地区：[1]广州康盛生物科技股份有限公司,广东省血液净化吸附技术企业重点实验室,广州510660 [2]广州科技贸易职业学院,广州511442

出　　处：《中国血液净化》2025年第1期71-74,共4页Chinese Journal of Blood Purification

基　　金：广东省药品监督管理局科技创新项目(2023TDB38)。

摘　　要：现行透析用水国际标准是ISO 23500-3:2019《血液透析及相关治疗用液体制备及质量管理指南第3部分:血液透析及相关治疗用水》,本文对其发展沿革和变迁进行了梳理,并从取样及储存、化学污染物、微生物限度等方面展开分析及探讨其技术要求,以加深相关从业人员对该标准的理解。The current international standard for dialysis water is ISO 23500-3:2019,“Preparation and quality management of fluids for hemodialysis and related therapies-Part 3:Water for hemodialysis and relat-ed therapies”.In this paper we analyzed and discussed the technical requirements from the aspects of sam-pling and storage,chemical contaminant limits,microbiological limits,and others,in order to better under-stand the standard for relevant practitioners.

关 键 词：透析用水 化学污染物 微生物限度 ISO 23500-3 

分 类 号：R19[医药卫生—卫生事业管理]