UNE-EN ISO 10993-3:2015
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
Spanish, Castilian, English
06-05-2015
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Genotoxicity tests
4.1 General
4.2 Test strategy
4.3 Sample preparation
4.4 Test methods
4.4.1 In vitro genotoxicity tests
4.4.2 In vivo genotoxicity tests
5 Carcinogenicity tests
5.1 General
5.2 Test strategy
5.3 Sample preparation
5.4 Test methods
6 Reproductive and developmental toxicity tests
6.1 General
6.2 Test strategy
6.3 Sample preparation
6.4 Test methods
7 Test report
Annex A (informative) Cell transformation test system
Annex B (informative) Rationale of test systems
Annex C (informative) Role of implantation
carcinogenicity studies
Bibliography
Gives strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Also provides guidance on selection of tests.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 30993-3. (04/2004)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-3:2014 | Identical |
| NBN EN ISO 10993-3 : 2014 | Identical |
| NEN EN ISO 10993-3 : 2014 | Identical |
| NS EN ISO 10993-3 : 2014 | Identical |
| I.S. EN ISO 10993-3:2014 | Identical |
| SN EN ISO 10993-3 : 2014 | Identical |
| UNI EN ISO 10993-3 : 2015 | Identical |
| BS EN ISO 10993-3:2014 | Identical |
| EN ISO 10993-3:2014 | Identical |
| NF EN ISO 10993-3 : 2014 | Identical |
| DIN EN ISO 10993-3:2015-02 | 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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