中国血液净化

中国血液净化 ›› 2024, Vol. 23 ›› Issue (09): 641-645.doi: 10.3969/j.issn.1671-4091.2024.09.001

• 指南与共识 •    下一篇

YY 0793.3-2023《血液透析和相关治疗用液体的制备和质量管理 第3部分：血液透析和相关治疗用浓缩物》标准解读

徐苏华    骆庆峰    刘国光    黄麒谕    黄敏菊   

  1. 510663 广州，1广东省医疗器械质量监督检验所
    100081 北京，2国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2024-04-12 修回日期:2024-06-06 出版日期:2024-09-12 发布日期:2024-09-12
  • 通讯作者: 徐苏华 E-mail:549561374@qq.com
  • 基金资助:
    广东省药品监督管理局2023年科技创新项目(2023YDZ08)

Interpretation of the standard YY 0793.3-2023 preparation and quality management of fluids for haemodialysis and related therapies-part 3: Concentrates for haemodialysis and related therapies

XU Su-hua, LUO Qing-feng, LIU Guo-guang, HUANG Qi-yu, HUANG Min-ju   

  1. Guang Dong Medical Devices Quality Surveillance and Test Institute; 2Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
  • Received:2024-04-12 Revised:2024-06-06 Online:2024-09-12 Published:2024-09-12
  • Contact: 510663 广州，1广东省医疗器械质量监督检验所 E-mail:549561374@qq.com

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摘要： YY 0793.3-2023《血液透析和相关治疗用液体的制备和质量管理 第3部分：血液透析和相关治疗用浓缩物》将于2025年07月01日开始实施。本文将YY 0793.3-2023与YY 0598-2015、ISO 23500-4:2019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、化学原辅料的要求、溶质浓度及试验方法、微生物限度及其试验方法、pH值、在线使用联机B干粉的pH值及溶质浓度，最终帮助相关企业理解运用该标准。

关键词: 血液透析浓缩物, 化学原辅料, 溶质浓度, 微生物限度, pH值

Abstract: YY 0793.3-2023《Preparation and Quality Control of fluids for hemodialysis and related Therapeutics - Part 3: Concentrates for hemodialysis and related Therapeutics》 will come into force on July 1, 2025. This article compares YY 0793.3-2023 with YY 0598-2015 and ISO 23500-4:2019, and interprets the differences in some important clauses, including the scope of application of the standard, requirements for chemical raw materials, solute concentration and testing methods, microbial limits and testing methods, pH value, pH value and solute concentration of online use of B dry powder, ultimately helping relevant enterprises understand and apply the standard.

Key words: Concentrates for hemodialysis, Chemical raw materials and excipients, Solute concentrations, Microbial limit, pH

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