中国血液净化

中国血液净化 ›› 2025, Vol. 24 ›› Issue (10): 868-870.doi: 10.3969/j.issn.1671-4091.2025.10.016

• 血液净化中心管理 • 上一篇    下一篇

柠檬酸消毒液注册常见问题分析

湛 娜   刘蕊一   刘蔚晨   

  1. 100081 北京，1国家药品监督管理局医疗器械技术审评中心
    200120 上海，2国家药品监督管理局医疗器械技术审评检查长三角分中心
  • 收稿日期:2024-10-08 修回日期:2025-07-01 出版日期:2025-10-12 发布日期:2025-10-12
  • 通讯作者: 湛娜 E-mail:zhanna@cmde.org.cn

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

摘要： 柠檬酸消毒液广泛应用于透析机内部管路的清洗和消毒，其安全有效性影响透析机使用的效果。本文对柠檬酸消毒液注册常见问题进行分析，结合现行标准和产品注册指导原则，对常见和疑难问题举例说明，为注册申报提供指导。

关键词: 柠檬酸消毒液, 注册监管

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

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