YY/T 1512-2017: Translated English of Chinese Standard. YY/T1512-2017: Biological Evaluation of Medical Devices - Guidance on the Conduct of Biological Evaluation within a Risk Management Process

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https://www.chinesestandard.net, 10 août 2018 - 26 pages
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This Standard is applicable to the biological evaluation of medical devices in accordance with the requirements in GB/T 16886.1-2011. This Standard does not add or modify the requirements in GB/T 16886.1-2011. This Standard does not include requirements of regulatory inspection or certification and assessment activities. This Standard is applicable to all the biological evaluation of various types of medical devices, including active, passive, implantable and non-implantable medical devices.
 

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Table des matières

Foreword
3
Biological Evaluation is a Risk Management Activity
9
Guidance of Biological Evaluation in Specific Aspects
17
References
25

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À propos de l'auteur (2018)

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