Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk management
4.2 Information supplied by the manufacturer
4.3 Materials
5 Functional requirements and test methods
5.1 General
5.2 Design
5.3 User interface
5.4 Controlled functions
6 Technical safety requirements and test methods
Annex A (informative) Guidance notes
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC