00/561676 DC : DRAFT APRIL 2000

Superseded

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DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY

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Superseded date: 31-10-2003

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

Table of Contents - (Show below) - (Hide below)

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

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BS EN ISO 10993-3.

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Comment Closes On
Committee	CH/26
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 10993-3:2014

Standards Referencing This Book - (Show below) - (Hide below)

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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