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AS ISO 10993.14-2003

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

06-30-2017

Language(s)

English

Published date

01-01-2003

Publisher

Standards Australia

Preview

Specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification, together with guidance on the analysis of these solutions in order to identify degradation products. This Standards considers only those degradation products generated by a chemical dissociation of ceramics during in-vitro testing.

This part of ISO 10993 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 ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first.This part of ISO 10993 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 ISO 10993 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 ISO 10993.

Committee
HE-012
DocumentType
Standard
ISBN
0 7337 5372 8
Pages
11
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-14:2001 Identical

First published as AS ISO 10993.14-2003.

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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