NEN 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
12-01-2013
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
Defines strategies for hazard identification and tests on medical devices for the following biological aspects: - genotoxicity; - carcinogenicity; - reproductive and developmental toxicity.
| DevelopmentNote |
Supersedes NEN ISO 10993-3. (12/2003)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-3:2014 | Identical |
| I.S. EN ISO 10993-3:2014 | Identical |
| BS EN ISO 10993-3:2014 | Identical |
| EN ISO 10993-3:2014 | Identical |
| UNI EN ISO 10993-3 : 2015 | Identical |
| UNE-EN ISO 10993-3:2015 | Identical |
| DIN EN ISO 10993-3:2015-02 | Identical |
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