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

Standard No.

GB/T 16886.15-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 16886.15-2022

Replace

GB/T 16886.15-2003

Scope

This document specifies general requirements for the design of qualitative and quantitative experiments for the degradation products of final metallic medical devices or corresponding material samples available 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 metal 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 chemistry described 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 carry out 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.

GB/T 16886.15-2022 Referenced Document

• ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 3585 Borosilicate glass 3.3 - Properties
• ISO 3696 Water for analytical laboratory use; Specification and test methods
• ISO 8044 Corrosion of metals and alloys — Vocabulary

GB/T 16886.15-2022 history

• 2022 GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
• 2003 GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys

GB/T 16886.15-2022 -All Parts