EN ISO 5840-2:2015

European foreword
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) - Heart valve substitute hazards,
        associated failure modes, and evaluation methods
Annex B (informative) - In vitro procedures for testing
        unstented or similar valves in compliant chambers
Annex C (informative) - Preclinical in vivo evaluation
Annex D (informative) - Description of the surgical heart
        valve substitute
Annex E (informative) - Examples of components of some
        surgical heart valve substitutes
Annex F (informative) - Guidelines for verification of
        hydrodynamic performance
Annex G (informative) - Durability testing
Annex H (informative) - Examples of design specific testing
Annex I (informative) - Fatigue assessment
Annex J (normative) - Methods of evaluating clinical data
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices

ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical 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 surgical 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 surgical heart valve substitute.ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840‑3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.ISO 5840-2:2015 excludes homografts.