Chinese Journal of Blood Purification

Chinese Journal of Blood Purification ›› 2024, Vol. 23 ›› Issue (09): 641-645.doi: 10.3969/j.issn.1671-4091.2024.09.001

    Next Articles

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

PDF

36

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

CLC Number: