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血液净化中心管理

透析用水国际标准的理解与探讨

  • 罗丽华 ,
  • 叶晓燕 ,
  • 王升升 ,
  • 杨正根 ,
  • 唐友洪 ,
  • 张乐宇
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  • 510660 广州,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 
    511442 广州,2广州科技贸易职业学院

收稿日期: 2024-05-27

  修回日期: 2024-09-18

  网络出版日期: 2025-01-12

基金资助

广东省药品监督管理局科技创新项目(2023TDB38)

Understanding and discussion of the international standard of dialysis water

  • LUO Li-Hua ,
  • YE Xiao-Yan ,
  • WANG Sheng-Sheng ,
  • YANG Zheng-Gen ,
  • TANG You-Hong ,
  • ZHANG Le-Yu
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  • Guangzhou Kangsheng BioScience Co., LTD., Guangzhou 510660, China; 2Guangzhou Vocational College of Technology & Business, Guangzhou 511442, China

Received date: 2024-05-27

  Revised date: 2024-09-18

  Online published: 2025-01-12

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。

本文引用格式

罗丽华 , 叶晓燕 , 王升升 , 杨正根 , 唐友洪 , 张乐宇 . 透析用水国际标准的理解与探讨[J]. 中国血液净化, 2025 , 24(01) : 71 -74 . DOI: 10.3969/j.issn.1671-4091.2025.01.015

Abstract

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 related therapies”. In this paper we analyzed and discussed the technical requirements from the aspects of sampling and storage, chemical contaminant limits, microbiological limits, and others, in order to better understand the standard for relevant practitioners.

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