PD ISO/TR 10993-33:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
Hardcopy , PDF
English
31-03-2015
14-09-2026
Foreword
Introduction
1 Scope
2 Selection of tests
3 Recommended tests
4 Use of in vitro tests to detect genotoxicity
5 Use of in vivo tests to detect genotoxicity
6 Bacterial reverse mutation assay
7 In vitro mammalian chromosome aberration test
8 In vitro mammalian micronucleus test
9 In vitro mammalian cell gene mutation test using
mouse lymphoma (L5178Y) cells
10 In vivo mammalian erythrocyte micronucleus test
11 Chromosome aberration test (in vivo)
Bibliography
Gives background information to facilitate the selection of tests and guidance on the performance of tests.
| Committee |
CH/194
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this Technical Report is to provide background information to facilitate the selection of tests and guidance on the performance of tests.
| Standards | Relationship |
| ISO/TR 10993-33:2015 | Identical |
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