00/561676 DC : DRAFT APRIL 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
10-31-2003
11-23-2012
Foreword
1 Scope
2 Normative references
3 Definitions
4 Genotoxicity tests
4.1 General
4.2 Sample preparation
4.3 Test methods
4.4 Test strategy
5 Carcinogenicity tests
5.1 General
5.2 Sample preparation
5.3 Test methods
5.4 Test strategy
6 Reproductive toxicity tests
6.1 General
6.2 Sample preparation
6.3 Test methods
6.4 Test strategy
7 Test report
Annex A (informative) Flow chart for genotoxicity testing
Annex B (informative) Bibliography
Annex C (informative) Cell transformation systems
Annex D (informative) Carcinogenicity tests performed as
implantation tests
Annex E (informative) rationale of test systems
BS EN ISO 10993-3.
| Committee |
CH/26
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| 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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