NS EN ISO 10993-1 : 2009 COR 2010

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

Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.