DR 03508 CP
Superseded
Superseded
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Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
Published date
10-13-2003
Publisher
Superseded date
06-30-2017
Superseded by
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Proposes adoption of ISO 10993-17:2002 to provide a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
| CommentClosesDate |
12-02-2003
|
| Committee |
HE-012
|
| DocumentType |
Draft
|
| PublisherName |
Standards Australia
|
| Status |
Superseded
|
| SupersededBy |
To be AS ISO 10993.17
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