中国血液净化

中国血液净化 ›› 2024, Vol. 23 ›› Issue (12): 891-895.doi: 10.3969/j.issn.1671-4091.2024.12.002

• 指南与共识 • 上一篇    下一篇

YY 0793.2-2023《血液透析和相关治疗用液体的制备和质量管理 第2部分：血液透析和相关治疗用水》标准解读

徐苏华    刘国光    黄麒谕    许朝生    陈华燕    黄敏菊   

  1. 510663 广州，1广东省医疗器械质量监督检验所 2国家药品监督管理局体外循环器械重点实验室
  • 收稿日期:2024-05-23 修回日期:2024-07-05 出版日期:2024-12-12 发布日期:2024-12-12
  • 通讯作者: 徐苏华 E-mail:549561374@qq.com
  • 基金资助:

Interpretation of the standard YY 0793.2-2023 “Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies; part 2: Water for Hemodialysis and Related Therapies”

XU Su-hua, LIU Guo-guang, HUANG Qi-yu, XU Chao-sheng, CHEN Hua-yan, HUANG Min-ju   

  1. Guangdong Medical Devices Quality Surveillance and Test Institute; 2Key Laboratory for Extracorporeal Circulation Devices, National Medical Products Administration, Guangzhou 510663, China
  • Received:2024-05-23 Revised:2024-07-05 Online:2024-12-12 Published:2024-12-12
  • Contact: 510663 广州，1广东省医疗器械质量监督检验所 2国家药品监督管理局体外循环器械重点实验室 E-mail:549561374@qq.com

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摘要： YY 0793.2-2023《血液透析和相关治疗用液体的制备和质量管理 第2部分：血液透析和相关治疗用水》已于2023年11月22日发布，将于2026年12月1日开始实施。本文将YY 0793.2-2023与YY 0572-2015、ISO 23500-3:2019进行对比，并对部分重要条款的差异进行解读，包括标准适用范围、质量要求、微生物要求和检测方法、化学污染物要求和检测方法，最终帮助相关企业理解运用该标准。

关键词: 血液透析和相关治疗用水, 微生物, 化学污染物

Abstract: The standard YY 0793.2-2023 “Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies; part 2: Water for Hemodialysis and Related Therapies” was released on November 22, 2023, and will be implemented from December 1, 2026. This article compares this standard with the standards YY 0572-2015 and ISO 23500-3:2019, and interprets the differences in several important clauses, including the scope of application, quality requirements, microbiological requirements and their detection methods, chemical pollutants requirements and their detection methods. Ultimately, it will help relevant enterprises understand and apply this standard.

Key words: Water for hemodialysis and related treatment, Microorganism, Chemical pollutant

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