I.S. EN ISO 10993-3:2014
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
Hardcopy , PDF
English
01-01-2014
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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
Describes 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.
| DevelopmentNote |
Supersedes I.S. EN 30993-3 (12/2003)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-3:2014 | Identical |
| NBN EN ISO 10993-3 : 2014 | Identical |
| BS EN ISO 10993-3:2014 | Identical |
| UNE-EN ISO 10993-3:2015 | Identical |
| ISO 10993-3:2014 | Identical |
| NS EN ISO 10993-3 : 2014 | Identical |
| SN EN ISO 10993-3 : 2014 | Identical |
| DIN EN ISO 10993-3:2015-02 | Identical |
| NF EN ISO 10993-3 : 2014 | Identical |
| UNI EN ISO 10993-3 : 2015 | Identical |
| NEN EN ISO 10993-3 : 2014 | Identical |
| 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 |
| ASTM C 1439 : 2013 : REDLINE | Standard Test Methods for Evaluating Latex and Powder Polymer Modifiers for use in Hydraulic Cement Concrete and Mortar |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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