Table of Contents

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
        document
Annex B (informative) - Examples of heart valve repair
        devices and delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions for use,
        and training
Annex E (normative) - Sterilization
Annex F (informative) - Heart valve repair system characteristics
Annex G (informative) - Heart valve repair system hazards,
        associated failure modes and evaluation methods
Annex H (informative) - In vitro test guidelines for
        paediatric devices
Annex I (informative) - Examples and definitions of some
        physical and material properties of heart valve repair
        device components
Annex J (informative) - Examples of standards applicable
        to testing of materials and components of heart valve
        repair devices
Annex K (informative) - Considerations for device material
        properties undergoing alterations post implantation
Annex L (informative) - Corrosion assessment
Annex M (informative) - Guidelines for in vitro evaluation
        of functional performance of the repair
Annex N (informative) - Durability testing
Annex O (informative) - Fatigue assessment
Annex P (informative) - Preclinical in vivo evaluation
Annex Q (normative) - Adverse event classification during
        clinical investigation
Annex R (informative) - Imaging protocol
Annex S (informative) - Clinical investigation endpoints
        for valve repair devices: Suggestions for endpoints
        and their timing
Annex T (informative) - Additional device design evaluation
        requirements
Annex U (informative) - Guidelines for delivery system
        design evaluation
Bibliography

Abstract

Pertains to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus).

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
ProductNote	This Standard is also refer as ISO 5840‑2:2015,ISO 5840‑1:2015,ISO 5840‑3:2013,ISO 10555‑1, ISO 10993‑4:2017,ISO/TS 11139,ISO 25539‑1,ISO/IEC Guide 51:2014,IEC 60601‑1,ASTM F1830 – 97:2013,
Pages
ISBN
Committee	TC 150