ISO/TR 10993-33:2015
(Main)Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
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.
Évaluation biologique des dispositifs médicaux — Partie 33: Directives sur les essais pour évaluer la génotoxicité — Supplément à l'ISO 10993-3
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 10993-33
First edition
2015-03-01
Biological evaluation of medical
devices —
Part 33:
Guidance on tests to evaluate
genotoxicity — Supplement to ISO
10993-3
Évaluation biologique des dispositifs médicaux —
Partie 33: Directives sur les essais pour évaluer la génotoxicité —
Supplément à l’ISO 10993-3
Reference number
©
ISO 2015
© ISO 2015
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Contents Page
Foreword .vi
Introduction .viii
1 Scope . 1
2 Selection of tests . 1
3 Recommended tests . 1
4 Use of in vitro tests to detect genotoxicity. 2
5 Use of in vivo tests to detect genotoxicity . 2
6 Bacterial reverse mutation assay . 3
6.1 General . 3
6.2 Preparations . 3
6.2.1 Bacteria . 3
6.2.2 Medium . 4
6.2.3 Metabolic activation . 4
6.2.4 Test sample preparation. 4
6.3 Test conditions . 4
6.3.1 Solvents . 4
6.3.2 Exposure concentrations . 5
6.3.3 Controls . 6
6.4 Procedure . 7
6.4.1 Treatment with test sample . 7
6.4.2 Incubation . 7
6.4.3 Data collection . 7
6.5 Data and reporting . 8
6.5.1 Treatment of results. 8
6.5.2 Evaluation and interpretation of results . 8
6.5.3 Criteria for a valid test . 8
6.5.4 Test report . 9
7 In vitro mammalian chromosome aberration test .11
7.1 General .11
7.2 Preparations .11
7.2.1 Cells .11
7.2.2 Media and culture conditions .11
7.2.3 Preparation of cultures . .11
7.2.4 Metabolic activation .11
7.2.5 Test sample preparation.12
7.3 Test conditions .12
7.3.1 Solvents .12
7.3.2 Exposure concentrations .12
7.3.3 Controls .13
7.4 Procedure .14
7.4.1 Treatment with test sample or extract and harvest time .14
7.4.2 Chromosome preparation .14
7.4.3 Analysis .14
7.5 Data and reporting .15
7.5.1 Treatment of results.15
7.5.2 Evaluation and interpretation of results .15
7.5.3 Test report .15
Contents Page
8 In vitro mammalian micronucleus test .17
8.1 General .17
8.2 Preparations .18
8.2.1 Cells .18
8.2.2 Media and culture conditions .18
8.2.3 Preparation of cultures . .18
8.2.4 Metabolic activation .18
8.2.5 Use of cytoB as a cytokinesis blocker .18
8.2.6 Test sample preparation.19
8.3 Test conditions .19
8.3.1 Solvents .19
8.3.2 Exposure concentrations .19
8.3.3 Controls .20
8.4 Procedure .21
8.4.1 Treatment with test sample or extract and harvest time .21
8.4.2 Cell harvest and slide preparation . .21
8.4.3 Analysis .22
8.5 Data and reporting .22
8.5.1 Treatment of results.22
8.5.2 Evaluation and interpretation of results .22
8.5.3 Test report .23
9 In vitro mammalian cell gene mutation test using mouse lymphoma (L5178Y) cells .25
9.1 General .25
9.2 Preparations .25
9.2.1 Cells .25
9.2.2 Media and culture conditions .25
9.2.3 Preparation of cultures .
...
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