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陈敏.邓刚.贺伟罡.姜琳琳.袁鹏.医疗器械安全有效基本要求清单在技术审评过程中的运用研究[J].中国医疗器械信息,2018, 24(7)
GHTF. Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) [EB/OL]. [2008-02-21].
http://www.imdrf.org.
GHTF. Essential Principles of Safety and Performance of Medical Devices.[EB/OL].[2012-11-02].http://www.imdrf.org.
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