PREN ISO 5840-3 : DRAFT 2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Verification testing and analysis/Design validation
Annex A (informative) - Rationale for the provisions
        of this International Standard
Annex B (informative) - Minimally invasive heart
        valve substitute hazards, associated failure
        modes and evaluation methods
Annex C (informative) - Examples and definitions of
        some physical and material properties of
        heart valve substitutes and their components
Annex D (informative) - Statistical procedures when
        using performance criteria
Annex E (informative) - In vitro test guidelines for
        paediatric devices
Annex F (informative) - Preclinical in vivo evaluation
Annex G (informative) - Echocardiographic protocol
Annex H (informative) - Valve description
Annex I (informative) - Examples of minimally invasive
        heart valve substitutes, components and
        delivery systems
Annex J (informative) - Examples of standards applicable
        to testing of materials and components of
        some heart valve substitutes
Annex K (informative) - Guidelines for verification of
        hydrodynamic performance
Annex L (informative) - Durability testing
Annex M (informative) - Fatigue assessment
Annex N (normative) - Packaging
Annex O (normative) - Product labels, instructions for
        use, and training
Annex P (normative) - Adverse event classification
        during clinical investigation
Annex Q (normative) - Sterilization
Annex R (informative) - Raw and post-conditioning
        mechanical properties
Annex S (informative) - Corrosion assessment
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42

Describes an approach for qualifying the design and manufacture of a minimally invasive heart valve substitute through risk management.