UNI 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

Gives advice on the fundamental principles governing the biological evaluation of medical devices; and the selection of appropriate tests. Also helps with the definition of categories of devices based on the nature and duration of contact with the body. Also gives detailed definitions, tables and annexes.