中国血液净化

中国血液净化 ›› 2021, Vol. 20 ›› Issue (06): 365-366.doi: 10.3969/j.issn.1671-4091.2021.06.02

• 管理·全民健康助力全面小康 • 上一篇    下一篇

柠檬酸消毒液技术审评概要简介

骆庆峰1,杨宇希1,王永清1   

  1. 1国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2021-03-18 修回日期:2021-04-02 出版日期:2021-06-12 发布日期:2021-06-17
  • 通讯作者: 骆庆峰 lqf0016017@126.com E-mail:lqf0016017@126.com

Brief introduction of technical review of citric acid disinfectant

  1.  1Center for medical device evaluation, NMPA, Beijing 100081, China
  • Received:2021-03-18 Revised:2021-04-02 Online:2021-06-12 Published:2021-06-17

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摘要： 【摘要】随着血液透析相关治疗方式的普及，血液透析设备配套的柠檬酸消毒液用量显著增加。为进一步规范其质量评价要点，帮助企业研究和生产，本文根据法规和国家标准，总结近期技术审评原则要求，对柠檬酸消毒液审评重点进行概要介绍，供生产、技术审评等单位部门参考。

关键词: 柠檬酸消毒液, 技术审评

Abstract: 【Abstract】With the popularization of hemodialysis-related treatments, the amount of citric acid disinfectant used in hemodialysis equipment has increased significantly. To further standardize the key points of its quality evaluation and help enterprises in research and production, this article summarizes recent technical review principles and requirements by regulations and national standards. It provides an overview of the key points of citric acid disinfectant review for departments of production, technical review and others.

Key words: Citric acid disinfectant, Technical review

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