GB/T 16886.14-2003
Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics (English Version)

Standard No.

GB/T 16886.14-2003

Language

Chinese, Available in English version

Release Date

2003

Published By

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

Latest

GB/T 16886.14-2003

Scope

This part of GB/T 16886 specifies two methods for obtaining solutions for the quantification of degradation products from ceramic materials (including glass). In addition, guidance is given for analyzing these solutions to characterize degradation products. Because this part of GB/T 16886 is a general standard, if there is a specific product standard that discusses the formation of degradation products that is closer to the use conditions, it should be given priority. This part of GB/T 16886 only considers the degradation products produced by chemical dissociation of ceramic materials during in vitro tests, and does not consider the degradation caused by mechanical stress or external energy. It should be noted that while ISO 6872 and ISO 9693 specify chemical degradation tests, they do not specify methods for analyzing degradation products. Due to the wide range of ceramic materials used in medical devices and the varying requirements for precision and accuracy of results, no specific analytical technique is specified. This part of GB/T 16886 does not specify specific requirements for acceptable levels of degradation products. Although these materials will be used in biomedicine, this part of GB/T 16886 does not specify the biological activity of degradation products.

GB/T 16886.14-2003 history

• 2003 GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics

GB/T 16886.14-2003 -All Parts