EN ISO 5840-3:2013

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 5840
Annex B (informative) - Examples of transcatheter heart
        valve substitutes, components and delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions for
        use and training
Annex E (normative) - Sterilization
Annex F (informative) - Valve description
Annex G (informative) - Transcatheter heart valve substitute
        hazards, associated failure modes and
        evaluation methods
Annex H (informative) - In vitro test guidelines for
        paediatric devices
Annex I (informative) - Statistical procedures when
        using performance criteria
Annex J (informative) - Examples and definitions of
        some physical and material properties of
        transcatheter heart valve substitutes and
        their components
Annex K (informative) - Examples of standards applicable
        to testing of materials and components of
         transcatheter heart valve substitutes
Annex L (informative) - Raw and post-conditioning
        mechanical properties for support structure
        materials
Annex M (informative) - Corrosion assessment
Annex N (informative) - Guidelines for verification of
        hydrodynamic performance
Annex O (informative) - Durability testing
Annex P (informative) - Fatigue assessment
Annex Q (informative) - Preclinical in vivo evaluation
Annex R (normative) - Adverse event classification
        during clinical investigation
Annex S (informative) - Echocardiographic protocol
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.ISO 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.ISO 5840-3:2013 is applicable to both newly developed and modified transcatheter 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.