National foreword
National Annex NA (informative) - Bibliography
European foreword
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
Bibliography