14/30270462 DC : 0

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification testing and analysis/Design
  validation
Annex A (informative) - Rationale for the
        provisions of this International Standard
Annex B (normative) - Packaging
Annex C (normative) - Product labels, instructions
        for use, and training
Annex D (normative) - Sterilization
Annex E (informative) - In vitro test guidelines
        for paediatric devices
Annex F (informative) - Statistical procedures
        when using in vitro performance criteria
Annex G (informative) - Examples and definitions
        of some physical and material properties of
        heart valve systems
Annex H (informative) - Examples of standards
        applicable to testing of materials and
        components of heart valve systems
Annex I (informative) - Raw and post-conditioning
        mechanical properties for support structure
        materials
Annex J (informative) - Corrosion assessment
Annex K (informative) - Echocardiographic protocol
Bibliography
Annex ZA (informative) - Relationship
         between this European Standard
         and the Essential Requirements of
         EU Directive 93/42/EEC on medical
         devices

BS EN ISO 5840-1.