DIN EN ISO 5840-1 E : 2015

National foreword
National Annex NA (informative) - Bibliography
European foreword.
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 part of ISO 5480
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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices
Bibliography

Pertains to heart valve substitutes intended for human implantation and provides general requirements.