AS ISO 10993.9-2002
Withdrawn
Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
01-01-2002
06-30-2017
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.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 4697 7
|
| Pages |
8
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 10993-9:1999 | Identical |
First published as AS ISO 10993.9-2002.
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