医用敷料进展及产品安全有效性研究简述

中国药物警戒 ›› 2012, Vol. 9 ›› Issue (5): 299-302.

医用敷料进展及产品安全有效性研究简述

张世庆¹，鲁景艳²，章金刚^2，*

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；
2 军事医学科学院野战输血研究所，北京 100850

收稿日期:2011-12-08 出版日期:2012-05-10 发布日期:2015-08-10
通讯作者: zhangjg@nic.bmi.ac.cn.
作者简介:张世庆，男，博士，助理研究员，医疗器械评价。

Summary of the Progress and Specifications for Safety and Effectiveness Regarding Dressing

ZHANG Shi-qing¹, LU Jing-yan², ZHANG Jin-gang^{2, *}

1 Center for Medical Device Evaluation of SFDA, Beijing 100044, China;
2 Institute of Transfusion Medicine, Academy of Military Medical Sciences, Beijing 100850, China

Received:2011-12-08 Online:2012-05-10 Published:2015-08-10

摘要/Abstract

摘要： 医用敷料是关乎公众健康的重要产品，近年来新产品层出不穷，然而由于缺乏研发和上市前评价相关技术指南，在一定程度上限制了该类产品的研发及上市。由此，本文就医用敷料研究进展及其安全有效性研究要点进行了简述，以供大家探讨。

关键词: 医用敷料, 进展, 评价

Abstract: Dressing is very important to the public health, and it developed quickly in recent years. But the progress of dressing is limited by the absence of related evaluation guidance. To help solving these problems, the progress and specifications for safety and effectiveness of dressing were discussed in this article.

Key words: dressing, progress, evaluation

张世庆，鲁景艳，章金刚. 医用敷料进展及产品安全有效性研究简述[J]. 中国药物警戒, 2012, 9(5): 299-302.

ZHANG Shi-qing, LU Jing-yan, ZHANG Jin-gang. Summary of the Progress and Specifications for Safety and Effectiveness Regarding Dressing[J]. Chinese Journal of Pharmacovigilance, 2012, 9(5): 299-302.

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