Foreword
Introduction
1 Scope
2 Terms and definitions
3 General principles applying to biological evaluation
of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation tests
7 Assurance of test methods
Annex A (informative) Rationale
Annex B (informative) Flow chart to aid in ensuring a
systematic approach to biological evaluation of
medical devices
Bibliography