Chinese Journal of Blood Purification

Chinese Journal of Blood Purification ›› 2025, Vol. 24 ›› Issue (10): 868-870.doi: 10.3969/j.issn.1671-4091.2025.10.016

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Analysis the registrational problems of citric acid disinfectant

ZHAN Na  LIU Rui-yi  LIU Wei-chen   

  1. Center for Medical Device Evaluation of National Medical Products Administration, Beijing 100081, China；2Yangtze River Delta Branch Center for Medical Device Evaluation and inspection of National Medical Products Administration, Shanghai 200120, China
  • Received:2024-10-08 Revised:2025-07-01 Online:2025-10-12 Published:2025-10-12
  • Contact: 100081 北京，1国家药品监督管理局医疗器械技术审评中心 E-mail:zhanna@cmde.org.cn

Abstract: The citric acid disinfectant is widely used for cleaning and disinfecting the internal tubing of dialysis machines. It's safety and validity affect the efficiency of dialyzer reuse. This article analyses the common problems of citric acid disinfectant registration, and combines the current standards and product registration guidelines to provide examples with usual difficulties for offering guidance of registration application.

Key words: Citric acid disinfectant, Registrational supervision

CLC Number: