Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests
6 Labelling
Annex A (informative) - Rationale for the
development and provisions of this
International Standard
Bibliography
Annex ZA (informative) - Relationship between
this European Standard and the
Essential Requirements of EU Directive
93/42/EEC on medical devices