AAMI ISO 5840-1 : 2016

Glossary of equivalent standards
Committee representation
Background on AAMI adoption of ISO 5840-1:2015
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 (normative) - Packaging
Annex C (normative) - Product labels, instructions
        for use, and training
Annex D (normative) - Sterilization
Annex E (informative) - In vitro test guidelines for
        pediatric 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

Pertains to heart valve substitutes intended for human implantation and provides general requirements.