ANSI/AAMI/ISO 10993-3:2014

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
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
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
Bibliography

Defines 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.