Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-1:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management process
Annex C (informative) - Suggested procedure for literature review
Bibliography