Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-03-2015

Publisher

British Standards Institution

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.

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.

Committee	CH/194
DocumentType	Standard
Pages	60
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
ISO/TR 10993-33:2015	Identical

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PD ISO/TR 10993-33:2015

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Category

Subcategory

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