Chinese Journal of Blood Purification

Chinese Journal of Blood Purification ›› 2024, Vol. 23 ›› Issue (12): 891-895.doi: 10.3969/j.issn.1671-4091.2024.12.002

Previous Articles     Next Articles

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

PDF

24

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

CLC Number: