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Norm

ÖNORM EN ISO 10993-9

Issue date: 1999 09 01

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and p...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German | English
Optionally co-design standards:
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. This part of ISO 10993 is not applicable to: a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components which are not degradation products. Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.
ÖNORM EN ISO 10993-9
2022 02 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification o...
Norm
ÖNORM EN ISO 10993-9
2010 04 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification o...
Norm
ÖNORM EN ISO 10993-9
2009 09 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification o...
Norm
ÖNORM EN ISO 10993-9
1999 09 01
Biological evaluation of medical devices - Part 9: Framework for identification and quantification o...
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