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BSI - BS EN ISO 10993-9

Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products

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Organization: BSI
Publication Date: 30 June 2009
Status: inactive
Page Count: 88
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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.

Document History

May 4, 2018
Draft BS EN ISO 10993-9 Biological evaluation of medical devices. Part 9: Framework for identification and quantification of potential degradation products.
A description is not available for this item.
June 30, 2010
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
A description is not available for this item.
June 30, 2010
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
A description is not available for this item.
June 30, 2009
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
A description is not available for this item.
BS EN ISO 10993-9
June 30, 2009
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
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...
June 15, 1999
Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
A description is not available for this item.
June 15, 1999
Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
A description is not available for this item.

References

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