GB/T 16886.18-2022: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

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Scope

This Document specifies a framework for the identification, and if necessary, quantification of
constituents of a medical device, allowing the identification of biological hazards and the
estimation and control of biological risks from material constituents, using a generally stepwise
approach to the chemical characterization.

Basic Data

Standard ID	GB/T 16886.18-2022 (GB/T16886.18-2022)
Description (Translated English)	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	65,673
Date of Issue	2022-12-30
Date of Implementation	2024-01-01
Older Standard (superseded by this standard)	GB/T 16886.18-2011
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration