11/30212473 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
Hardcopy , PDF
English
31-10-2014
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) - Rationale of test systems
Annex B (informative) - Cell transformation test
systems
Annex C (normative) - Considerations for carcinogenicity
studies performed as implantation studies
Annex D (normative) - Guidance on selecting an
appropriate sample preparation procedure in
genotoxicity testing
Annex E (informative) - Tests to evaluate genotoxicity
Annex F (informative) - In vitro tests for embryotoxicity
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directive 93/42/EC
BS EN ISO 10993-3.
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
80
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| 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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