EN ISO 5840:2009

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) - 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
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.It is applicable 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.ISO 5840:2005 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are 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 may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.