GB/T 16886.15-2022: Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

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Scope

This Document specifies general requirements for the design of tests for identifying and
quantifying degradation products from final metallic medical devices or corresponding material
samples finished as ready for clinical use.
This Document applies to materials that are expected and unintended to degrade in vivo and to
degradation products that result from chemical changes in the final metallic device during in
vitro degradation tests.
This Document does not apply to the evaluation of degradation occurring by purely mechanical
processes; the methodology for producing such degradation products is described in the specific
product standard, if available. This document does not cover the biological activity of
degradation products.
NOTE 1: Due to the nature of the in vitro test, the test results approximate the in vivo behavior of the
implant or material. The described chemistry is a means to generate degradation products for further
evaluation.
NOTE 2: Pure mechanical degradation mainly produces particulate debris. Although not included in the
scope of this Document, such degradation products can cause biological reactions, and perform
biological evaluation according to the methods described in other parts of GB/T(Z) 16886.
NOTE 3: Due to the wide variety of metallic materials used in medical devices, there is no specific
analytical technique to determine the quantification of degradation products. This document does not
involve the characterization of trace elements (mass fraction < 10-6) contained in specific metals or alloys,
nor does it provide specific requirements for acceptable levels of degradation products.

Basic Data

Standard ID	GB/T 16886.15-2022 (GB/T16886.15-2022)
Description (Translated English)	Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	20,225
Date of Issue	2022-12-30
Date of Implementation	2024-01-01
Older Standard (superseded by this standard)	GB/T 16886.15-2003
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration