中国血液净化

中国血液净化 ›› 2025, Vol. 24 ›› Issue (10): 793-797.doi: 10.3969/j.issn.1671-4091.2025.10.001

• 指南与共识 •    下一篇

YY/T 0793.4-2022《血液透析和相关治疗用液体的制备和质量管理 第4部分：血液透析和相关治疗用透析液质量》标准解读

柯 军    叶晓燕    何晓帆    张 云   

  1. 510663  广州，1广东省医疗器械质量监督检验所机械化学室
    511442  广州，2广州科技贸易职业学院生物技术与健康学院
    510663  广州，3国家药品监督管理局体外循环器械重点实验室
  • 收稿日期:2025-04-27 修回日期:2025-06-10 出版日期:2025-10-12 发布日期:2025-10-12
  • 通讯作者: 柯军 E-mail:gzkj2003@163.com
  • 基金资助:
    广州市高校其他改革类项目(2024QTGG021)

Interpretion of the standard YY/T 0793.4-2022 Preparation and quality management of fluids for hemodialysis and related therapies-Part 4: Quality of dialysis fluid for hemodialysis and related therapies

KE Jun, YE Xiao-yan, HE Xiao-fan, ZHANG Yun   

  1. Guang dong Medical Devices Quality Surveillance and Test Institute,Guangzhou 510663, China; 2Guangzhou Vocational College of Technology &Business, Guangzhou 511442, China; 3Key Laboratory for Extracorporeal Circulation Devices,National Medical Products Administration,Guangzhou 510663,China
  • Received:2025-04-27 Revised:2025-06-10 Online:2025-10-12 Published:2025-10-12
  • Contact: 510663 广州，1广东省医疗器械质量监督检验所机械化学 E-mail:gzkj2003@163.com

摘要： 本文分析了我国医药行业标准YY/T 0793.4-2022《血液透析和相关治疗用液体的制备和质量管理 第4部分：血液透析和相关治疗用透析液质量》与国际标准化组织(the International Organization for Standardization，ISO)23500-5:2019的差异，并对主要条款进行解读。通过对标准的深入分析，帮助临床机构进一步提升血液透析和相关治疗用透析液的质量，对保障患者临床安全具有重要作用。

关键词: 血液透析和相关治疗用透析液, 微生物污染物, 化学污染物

Abstract: This article analyzes the differences between the standard YY/T 0793.4-2022 and the international standard (the International Organization for Standardization, ISO) 23500-5:2019, and provides an interpretation of key clauses. Through in-depth analysis of the standards, it aims to help clinical institutions further improve the quality of dialysis fluids used in hemodialysis and related therapies, which playing a crucial role in ensuring patient clinical safety.

Key words: Dialysis fluid for hemodialysis and related therapies; , Microbiological contaminants; , Chemical contaminants

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