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Norm
ÖNORM EN ISO 10993-14
Issue date: 2002 05 01
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
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 ...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 19 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 10993-14
2009 09 15
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation...
Norm
ÖNORM EN ISO 10993-14
2002 05 01
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation...
Norm
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