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BS PD ISO/TR 10993-33 : 2015

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BS PD ISO/TR 10993-33 : 2015

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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Table of Contents

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>&nbsp;&nbsp;&nbsp;mouse lymphoma (L5178Y) cells<br>10 In vivo mammalian erythrocyte micronucleus test<br>11 Chromosome aberration test (in vivo)<br>Bibliography

Abstract

Gives background information to facilitate the selection of tests and guidance on the performance of tests.

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/194