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Norm
ÖNORM EN ISO 10993-9
Issue date: 2010 04 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
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Withdrawn: 2022 02 15
Publisher:
Austrian Standards International
Format:
Digital | 16 Pages
Language:
German
| English
| Download GER/ENG
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. Information
obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This
part of ISO 10993 considers both non-resorbable and resorbable materials.
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
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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 :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
1998 11 19
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Final Draft
Issue date :
2010 03 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Norm
Issue date :
2022 02 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Norm
Issue date :
2009 11 30
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products