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ISO 10993-9

Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products

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Organization: ISO
Publication Date: 1 March 1999
Status: inactive
Page Count: 15
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

April 23, 2019
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation...
December 15, 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...
ISO 10993-9
March 1, 1999
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...

References

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