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

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Scope

This Part of GB/T 16886 specifies two methods of obtaining solutions of degradation
products from ceramics (including glasses) for the purposes of quantification. It also
gives guidance on the analysis of these solutions in order to identify the degradation
products. Because of the generalized nature of this Part of GB/T 16886, product
specific standards, when available, that address degradation product formation under
more relevant conditions of use, should be considered first.
This Part of GB/T 16886 considers only those degradation products generated by a
chemical dissociation of ceramics during in vitro testing. No degradation induced by
mechanical stress or external energy is covered. It is noted that while ISO 6872 and
ISO 9693 cover chemical degradation tests, they do not address the analysis of
degradation products.
Because of the range of ceramics used in medical devices and the different
requirements for accuracy and precision of the results, no specific analytical
techniques are identified. Further, this Part of GB/T 16886 provides no specific
requirements for acceptable levels of degradation products.
Although these materials are intended for biomedical applications, the biological
activity of these degradation products is not addressed in this Part of GB/T 16886.

Basic Data

Standard ID	GB/T 16886.14-2003 (GB/T16886.14-2003)
Description (Translated English)	Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	12,146
Date of Issue	3/5/2003
Date of Implementation	8/1/2003
Adopted Standard	ISO 10993-14-2001, IDT
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China
Summary	This Standard specifies two from ceramic materials (including glass) with a solution of the product of quantitative methods to obtain degradation. Further analysis of these solutions are also given in order to degradation products qualitative guide.