AS ISO 10993.9-2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
30-06-2017
English
01-01-2002
Important note : Users cannot be edited or removed once added to your Multi user PDF.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Withdrawn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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