YY/T 1512-2017: Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

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Scope

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.

Basic Data

Standard ID	YY/T 1512-2017 (YY/T1512-2017)
Description (Translated English)	Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	14,140
Date of Issue	2017-07-17
Date of Implementation	2018-07-01
Issuing agency(ies)	State Food and Drug Administration