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) - 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

Abstract

Pertains 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 5840-2 : 60.00 (2015)