UNI EN ISO 5840 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
  6.1 Intended use
  6.2 Design inputs
  6.3 Design outputs
  6.4 Design transfer (manufacturing qualification)
  6.5 Risk management
7 Verification testing and analysis/Design validation
  7.1 General requirements
  7.2 In vitro assessment
  7.3 Preclinical in vivo evaluation
  7.4 Clinical investigation
Annex A (informative) - Rationale for the provisions of
        this International Standard
Annex B (informative) - Heart valve substitute hazards,
        associated failure modes and evaluation methods
Annex C (informative) - Risk assessment guidelines
Annex D (informative) - Examples and definitions of some
        physical and material properties of heart valve
        substitutes and their components
Annex E (informative) - Statistical procedures when using
        performance criteria
Annex F (informative) - In vitro procedures for testing
        unstented or similar valves in compliant chambers
Annex G (informative) - Preclinical in vivo tests
Annex H (informative) - Echocardiographic protocol
Annex I (informative) - Description of the heart valve
        substitute
Annex J (informative) - Figures of examples of components
        of some heart valve substitutes
Annex K (informative) - Examples of standards applicable
        to testing of materials and components of some heart
        valve substitutes
Annex L (informative) - Guidelines for verification of
        hydrodynamic performance
Annex M (informative) - Durability testing
Annex N (informative) - Examples of design specific testing
Annex O (informative) - Fatigue assessment
Annex P (normative) - Packaging
Annex Q (normative) - Labelling and instructions for use
Annex R (normative) - Methods of evaluating clinical data
Annex S (normative) - Sterilization
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Applies to all devices intended for implantation in human hearts, as a heart valve substitute. Also applies to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.