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
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices