UNI 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

Specifies an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management.