I.S. EN 30993-1:1995

Cooperating organizations
National foreword
Foreword
Introduction
Guide
1. Scope
2. Normative references
3. Definitions
4. General principles applying to biological evaluation
     of materials and devices
5. Categorization of medical devices
6. Testing
7. Guidance on selection of biological evaluation tests
8. Assurance of test methods
Annexes
A. (informative) Rationale
B. (informative) Bibliography of international and
     national standards and regulations
Tables
1. Guidance for initial evaluation tests
2. Guidance for supplementary evaluation tests
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references

Provides guidance on the fundamental principles governing the biological evaluation of medical devices; the definition of categories of devices based on the nature and duration of contact with the body; the selection of appropriate tests.