Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Product definition
6 Process definitions
7 User requirements
8 Validation
9 Routine monitoring and control
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on Active Implantable
         Medical Devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro diagnostic
         medical devices