中国药物警戒 ›› 2012, Vol. 9 ›› Issue (7): 421-423.

• 药械安全性研究 • 上一篇    下一篇

避光输注器具对临床用药安全性影响及上市前评价探讨

杨晓冬   

  1. 国家食品药品监督管理局医疗器械技术审评中心,北京 100044
  • 收稿日期:2012-03-06 出版日期:2012-07-10 发布日期:2015-08-07
  • 作者简介:杨晓冬,男,硕士,主治医师,无菌一次性医疗器械技术审评。

Safety Evaluation of Light-resistant Infusion Sets for Clinical Medication

YANG Xiao-dong   

  1. Center For Medical Device Evaluation, SFDA, Beijing 100045, China
  • Received:2012-03-06 Online:2012-07-10 Published:2015-08-07

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摘要： 本文着眼于避光输注器具类产品的具体特点,就该类产品对临床用药的安全性影响因素进行分析阐述,并对该类产品上市前生产企业应考虑的评价因素进行初步探讨,为避光输注器具类产品的研发与评价提供参考。

关键词: 避光输注器具, 安全性, 评价

Abstract: This article analysis factors influencing safety of clinical medication by focusing on specific characteristics of the light-resistant infusion sets. The evaluation factors which should be considered by manufacturing enterprises are preliminary discussed in order to provide reference for development and evaluation of the light-resistant infusion sets.

Key words: light-resistant infusion sets, safety, evaluation