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 B (informative) - Reference tables
from ISO 13959
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography