National foreword
National Annex NA (informative) - Bibliography
European Foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests for compliance with microbiological
requirements
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