ANSI/AAMI/ISO 10993-3:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
Hardcopy , PDF
04-11-2023
English
14-08-2014
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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.
| Committee |
WG 06
|
| DocumentType |
Standard
|
| ISBN |
1-57020-561-2
|
| Pages |
50
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-3:2014 | Identical |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| ISO/TR 10993-33:2015 | Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3 |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| CFR 40(PTS700-789) : JUL 2016 | PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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