DR 03177 CP
Superseded
Superseded
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Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
Published date
03-25-2003
Publisher
Superseded date
10-26-2017
Superseded by
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Proposes guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test.
| CommentClosesDate |
05-06-2003
|
| Committee |
HE-012
|
| DocumentType |
Draft
|
| PublisherName |
Standards Australia
|
| Status |
Superseded
|
| SupersededBy |
To be AS ISO 10993.15
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