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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 33: GUIDANCE ON TESTS TO EVALUATE GENOTOXICITY - SUPPLEMENT TO ISO 10993-3
British Standards Institution
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Availability date: 11/05/2021
Foreword<br>Introduction<br>1 Scope<br>2 Selection of tests<br>3 Recommended tests<br>4 Use of in vitro tests to detect genotoxicity<br>5 Use of in vivo tests to detect genotoxicity<br>6 Bacterial reverse mutation assay<br>7 In vitro mammalian chromosome aberration test<br>8 In vitro mammalian micronucleus test<br>9 In vitro mammalian cell gene mutation test using<br> mouse lymphoma (L5178Y) cells<br>10 In vivo mammalian erythrocyte micronucleus test<br>11 Chromosome aberration test (in vivo)<br>Bibliography
Gives background information to facilitate the selection of tests and guidance on the performance of tests.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/194 |