ISO/TR 10993-33:2015
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.
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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
6.1 General
6.2 Preparations
6.2.1 Bacteria
6.2.2 Medium
6.2.3 Metabolic activation
6.2.4 Test sample preparation
6.3 Test conditions
6.3.1 Solvents
6.3.2 Exposure concentrations
6.3.3 Controls
6.4 Procedure
6.4.1 Treatment with test sample
6.4.2 Incubation
6.4.3 Data collection
6.5 Data and reporting
6.5.1 Treatment of results
6.5.2 Evaluation and interpretation of results
6.5.3 Criteria for a valid test
6.5.4 Test report
7 In vitro mammalian chromosome aberration test
7.1 General
7.2 Preparations
7.2.1 Cells
7.2.2 Media and culture conditions
7.2.3 Preparation of cultures
7.2.4 Metabolic activation
7.2.5 Test sample preparation
7.3 Test conditions
7.3.1 Solvents
7.3.2 Exposure concentrations
7.3.3 Controls
7.4 Procedure
7.4.1 Treatment with test sample or extract and harvest time
7.4.2 Chromosome preparation
7.4.3 Analysis
7.5 Data and reporting
7.5.1 Treatment of results
7.5.2 Evaluation and interpretation of results
7.5.3 Test report
8 In vitro mammalian micronucleus test
8.1 General
8.2 Preparations
8.2.1 Cells
8.2.2 Media and culture conditions
8.2.3 Preparation of cultures
8.2.4 Metabolic activation
8.2.5 Use of cytoB as a cytokinesis blocker
8.2.6 Test sample preparation
8.3 Test conditions
8.3.1 Solvents
8.3.2 Exposure concentrations
8.3.3 Controls
8.4 Procedure
8.4.1 Treatment with test sample or extract and harvest time
8.4.2 Cell harvest and slide preparation
8.4.3 Analysis
8.5 Data and reporting
8.5.1 Treatment of results
8.5.2 Evaluation and interpretation of results
8.5.3 Test report
9 In vitro mammalian cell gene mutation test using mouse lymphoma (L5178Y) cells
9.1 General
9.2 Preparations
9.2.1 Cells
9.2.2 Media and culture conditions
9.2.3 Preparation of cultures
9.2.4 Metabolic activation
9.2.5 Test sample preparations
9.3 Test conditions
9.3.1 Solvent/vehicle
9.3.2 Exposure concentrations
9.3.3 Controls
9.4 Procedure
9.4.1 General
9.4.2 Treatment with test sample
9.4.3 Measurement of survival, viability and mutant frequency
9.5 Data and reporting
9.5.1 Treatment of results
9.5.2 Evaluation and interpretation of results
10 In vivo mammalian erythrocyte micronucleus test
10.1 General
10.2 Preparations
10.2.1 Selection of animal species
10.2.2 Housing and feeding conditions
10.2.3 Preparation of the animals
10.2.4 Test sample preparation
10.3 Test conditions
10.3.1 Solvent/vehicle
10.3.2 Controls
10.4 Procedure
10.4.1 Number and sex of animals
10.4.2 Treatment schedule
10.4.3 Limit test
10.4.4 Dose levels
10.4.5 Routes of administration and doses levels
10.4.6 Bone marrow/blood preparation
10.4.7 Analysis
10.5 Data and reporting
10.5.1 Evaluation of results
10.5.2 Evaluation and interpretation of results
10.5.3 Test report
11 Chromosome aberration test (in vivo)
11.1 General
11.2 Preparations
11.2.1 Selection of animal species
11.2.2 Housing and feeding conditions
11.2.3 Preparation of the animals
11.2.4 Test sample preparation
11.3 Test conditions
11.3.1 Solvent/vehicle
11.3.2 Controls
11.4 Procedure
11.4.1 Number and sex of animals
11.4.2 Treatment schedule
11.4.3 Dose levels
11.4.4 Limit test
11.4.5 Dose levels and routes of exposure
11.4.6 Bone marrow collection and preparation of slides
11.4.7 Analysis of Metaphase Cells
11.5 Data and reporting
11.5.1 Treatment of results
11.5.2 Evaluation and interpretation of results
11.5.3 Test report
Bibliography
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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
6.1 General
6.2 Preparations
6.2.1 Bacteria
6.2.2 Medium
6.2.3 Metabolic activation
6.2.4 Test sample preparation
6.3 Test conditions
6.3.1 Solvents
6.3.2 Exposure concentrations
6.3.3 Controls
6.4 Procedure
6.4.1 Treatment with test sample
6.4.2 Incubation
6.4.3 Data collection
6.5 Data and reporting
6.5.1 Treatment of results
6.5.2 Evaluation and interpretation of results
6.5.3 Criteria for a valid test
6.5.4 Test report
7 In vitro mammalian chromosome aberration test
7.1 General
7.2 Preparations
7.2.1 Cells
7.2.2 Media and culture conditions
7.2.3 Preparation of cultures
7.2.4 Metabolic activation
7.2.5 Test sample preparation
7.3 Test conditions
7.3.1 Solvents
7.3.2 Exposure concentrations
7.3.3 Controls
7.4 Procedure
7.4.1 Treatment with test sample or extract and harvest time
7.4.2 Chromosome preparation
7.4.3 Analysis
7.5 Data and reporting
7.5.1 Treatment of results
7.5.2 Evaluation and interpretation of results
7.5.3 Test report
8 In vitro mammalian micronucleus test
8.1 General
8.2 Preparations
8.2.1 Cells
8.2.2 Media and culture conditions
8.2.3 Preparation of cultures
8.2.4 Metabolic activation
8.2.5 Use of cytoB as a cytokinesis blocker
8.2.6 Test sample preparation
8.3 Test conditions
8.3.1 Solvents
8.3.2 Exposure concentrations
8.3.3 Controls
8.4 Procedure
8.4.1 Treatment with test sample or extract and harvest time
8.4.2 Cell harvest and slide preparation
8.4.3 Analysis
8.5 Data and reporting
8.5.1 Treatment of results
8.5.2 Evaluation and interpretation of results
8.5.3 Test report
9 In vitro mammalian cell gene mutation test using mouse lymphoma (L5178Y) cells
9.1 General
9.2 Preparations
9.2.1 Cells
9.2.2 Media and culture conditions
9.2.3 Preparation of cultures
9.2.4 Metabolic activation
9.2.5 Test sample preparations
9.3 Test conditions
9.3.1 Solvent/vehicle
9.3.2 Exposure concentrations
9.3.3 Controls
9.4 Procedure
9.4.1 General
9.4.2 Treatment with test sample
9.4.3 Measurement of survival, viability and mutant frequency
9.5 Data and reporting
9.5.1 Treatment of results
9.5.2 Evaluation and interpretation of results
10 In vivo mammalian erythrocyte micronucleus test
10.1 General
10.2 Preparations
10.2.1 Selection of animal species
10.2.2 Housing and feeding conditions
10.2.3 Preparation of the animals
10.2.4 Test sample preparation
10.3 Test conditions
10.3.1 Solvent/vehicle
10.3.2 Controls
10.4 Procedure
10.4.1 Number and sex of animals
10.4.2 Treatment schedule
10.4.3 Limit test
10.4.4 Dose levels
10.4.5 Routes of administration and doses levels
10.4.6 Bone marrow/blood preparation
10.4.7 Analysis
10.5 Data and reporting
10.5.1 Evaluation of results
10.5.2 Evaluation and interpretation of results
10.5.3 Test report
11 Chromosome aberration test (in vivo)
11.1 General
11.2 Preparations
11.2.1 Selection of animal species
11.2.2 Housing and feeding conditions
11.2.3 Preparation of the animals
11.2.4 Test sample preparation
11.3 Test conditions
11.3.1 Solvent/vehicle
11.3.2 Controls
11.4 Procedure
11.4.1 Number and sex of animals
11.4.2 Treatment schedule
11.4.3 Dose levels
11.4.4 Limit test
11.4.5 Dose levels and routes of exposure
11.4.6 Bone marrow collection and preparation of slides
11.4.7 Analysis of Metaphase Cells
11.5 Data and reporting
11.5.1 Treatment of results
11.5.2 Evaluation and interpretation of results
11.5.3 Test report
Bibliography