EN ISO 5840-1:2015

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) - Rationale for the provisions
        of this part of ISO 5480
Annex B (normative) - Packaging
Annex C (normative) - Product labels, instructions
        for use, and training
Annex D (normative) - Sterilization
Annex E (informative) - In vitro test guidelines for
        paediatric devices
Annex F (informative) - Statistical procedures when
        using in vitro performance criteria
Annex G (informative) - Examples and definitions of
        some physical and material properties of heart
        valve systems
Annex H (informative) - Examples of standards
        applicable to testing of materials and components
        of heart valve systems
Annex I (informative) - Raw and post-conditioning mechanical
        properties for support structure materials
Annex J (informative) - Corrosion assessment
Annex K (informative) - Echocardiographic protocol
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices

ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.ISO 5840-1:2015 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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.ISO 5840-1:2015 defines operational conditions for heart valve substitutes.ISO 5840-1:2015 excludes homografts.NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.