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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Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
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...
Norm
↖
Norm
Issue date :
2006 11 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
Norm
Issue date :
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
Issue date :
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
1992 12 30
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
Norm
Issue date :
1999 03 04
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
