EN ISO 10993-3:2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for test strategies
5 Genotoxicity tests
6 Carcinogenicity tests
7 Reproductive and developmental toxicity tests
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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42 EEC
         on medical devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 90/385/EEC on
         active implantable medical devices

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.