Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification and validation
Annex A (informative) Surgical heart valve substitute hazard analysis example
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 and system
Annex E (informative) Examples of components of some surgical heart valve substitutes and systems
Annex F (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing
Annex G (informative) Examples of design specific testing
Annex H (informative) Fatigue assessment
Annex I (normative) Methods of evaluating clinical data against objective performance criteria
Annex J (normative) Adverse event classification during clinical investigation
Bibliography