GB/T 16886.19-2022: Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

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Scope

This document provides a compilation of parameters and test methods that can be useful for the
identification and evaluation of the physical, i.e., physic‑chemical, morphological and
topographical (PMT) properties of materials in finished medical devices. Such an assessment
is limited to those properties that are relevant to biological evaluation and the medical device’s
intended use (clinical application and duration of use) even if such properties overlap with
clinical effectiveness.

Basic Data

Standard ID	GB/T 16886.19-2022 (GB/T16886.19-2022)
Description (Translated English)	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	18,162
Date of Issue	2022-12-30
Date of Implementation	2024-01-01
Older Standard (superseded by this standard)	GB/T 16886.19-2011
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration