National foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified
in the information provided by the medical
device manufacturer
5 Risk analysis
6 Information to be provided by the medical
device manufacturer
7 Presentation of the information
Annex A (informative) - Commonly utilized processing
methods
Annex B (informative) - Example of processing instructions
for reusable medical devices
Annex C (informative) - Classification of medical devices
Annex D (informative) - Additional guidance on information
to be provided by the medical device manufacturer
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices