ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
- genotoxicity;
- carcinogenicity;
- reproductive and developmental toxicity.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.3
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.2.3
Section sec_5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_6.4
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.4
Section sec_8
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.2.1
Annex sec_A.2.2
Annex sec_A.2.2.1
Annex sec_A.2.2.2
Annex sec_A.2.2.3
Annex sec_A.2.3
Annex sec_A.3
Annex sec_A.3.1
Figure fig_A.1
Table tab_A.1
Annex sec_A.3.2
Annex sec_A.3.3
Annex sec_A.3.3.1
Annex sec_A.3.3.2
Annex sec_A.3.3.3
Annex sec_A.3.3.4
Annex sec_A.3.4
Annex sec_A.3.4.1
Annex sec_A.3.4.2
Annex sec_A.3.4.2.1
Annex sec_A.3.4.2.2
Annex sec_A.3.4.2.3
Annex sec_A.3.4.2.4
Annex sec_A.3.4.2.5
Annex sec_A.4
Annex sec_A.4.1
Annex sec_A.4.2
Annex sec_A.4.3
Annex sec_B
Figure fig_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_D
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_F
Table tab_F.1
Table tab_F.2
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Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for test strategies
4.1 General
4.2 Additional requirements for carcinogenicity testing
4.3 Additional requirements for reproductive toxicity testing
5 Genotoxicity tests
5.1 General
5.2 Test strategy
5.3 Sample preparation
6 Carcinogenicity tests
6.1 General
6.2 Evaluation strategy
6.3 Sample preparation
6.4 Test methods
7 Reproductive and developmental toxicity tests
7.1 General
7.2 Test strategy
7.3 Sample preparation
7.4 Test methods
8 Test report
Annex A (informative) Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing
Annex B (informative) Flowchart for follow-up evaluation
Annex C (informative) Rationale of test systems
Annex D (informative) Cell transformation test systems
Annex E (normative) Considerations for carcinogenicity studies performed as implantation studies
Annex F (informative) In vitro tests for embryo toxicity
Bibliography
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.3
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.2.3
Section sec_5.3
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Section sec_6.4
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.4
Section sec_8
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.2.1
Annex sec_A.2.2
Annex sec_A.2.2.1
Annex sec_A.2.2.2
Annex sec_A.2.2.3
Annex sec_A.2.3
Annex sec_A.3
Annex sec_A.3.1
Figure fig_A.1
Table tab_A.1
Annex sec_A.3.2
Annex sec_A.3.3
Annex sec_A.3.3.1
Annex sec_A.3.3.2
Annex sec_A.3.3.3
Annex sec_A.3.3.4
Annex sec_A.3.4
Annex sec_A.3.4.1
Annex sec_A.3.4.2
Annex sec_A.3.4.2.1
Annex sec_A.3.4.2.2
Annex sec_A.3.4.2.3
Annex sec_A.3.4.2.4
Annex sec_A.3.4.2.5
Annex sec_A.4
Annex sec_A.4.1
Annex sec_A.4.2
Annex sec_A.4.3
Annex sec_B
Figure fig_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_D
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_F
Table tab_F.1
Table tab_F.2
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Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for test strategies
4.1 General
4.2 Additional requirements for carcinogenicity testing
4.3 Additional requirements for reproductive toxicity testing
5 Genotoxicity tests
5.1 General
5.2 Test strategy
5.3 Sample preparation
6 Carcinogenicity tests
6.1 General
6.2 Evaluation strategy
6.3 Sample preparation
6.4 Test methods
7 Reproductive and developmental toxicity tests
7.1 General
7.2 Test strategy
7.3 Sample preparation
7.4 Test methods
8 Test report
Annex A (informative) Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing
Annex B (informative) Flowchart for follow-up evaluation
Annex C (informative) Rationale of test systems
Annex D (informative) Cell transformation test systems
Annex E (normative) Considerations for carcinogenicity studies performed as implantation studies
Annex F (informative) In vitro tests for embryo toxicity
Bibliography