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