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ANSI/AAMI/ISO 10993-5:2009/(R)2014 - Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity >
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ANSI/AAMI/ISO 10993-5:2009/(R)2014 - Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, 2009
- ANSI/AAMI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices —Part 5: Tests for in vitro cytotoxicity
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of AAMI adoption of ISO 10993-5:2009
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Sample and control preparation [Go to Page]
- 5 Cell lines
- 6 Culture medium
- 7 Preparation of cell stock culture
- 8 Test procedures [Go to Page]
- 9 Test report
- 10 Assessment of results
- Annex A Neutral red uptake (NRU) cytotoxicity test [Go to Page]
- Annex B Colony formation cytotoxicity test [Go to Page]
- Annex C MTT cytotoxicity test [Go to Page]
- Annex D XTT cytotoxicity test [Go to Page]
- Bibliography [Go to Page]
