Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Abbreviations<br>5 Fundamental requirements<br>6 Device description<br>7 Design verification testing and analysis/design<br>&nbsp;&nbsp;validation<br>Annex A (informative) - Heart valve substitute hazards,<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;associated failure modes, and evaluation methods<br>Annex B (informative) - In vitro procedures for testing<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;unstented or similar valves in compliant chambers<br>Annex C (informative) - Preclinical in vivo evaluation<br>Annex D (informative) - Description of the surgical heart<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;valve substitute<br>Annex E (informative) - Examples of components of some<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;surgical heart valve substitutes<br>Annex F (informative) - Guidelines for verification of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;hydrodynamic performance<br>Annex G (informative) - Durability testing<br>Annex H (informative) - Examples of design specific testing<br>Annex I (informative) - Fatigue assessment<br>Annex J (normative) - Methods of evaluating clinical data<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directive 93/42/EEC<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;on medical devices

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	British Standards Institution
Pages
ISBN
Committee	CH/150/2
Supersedes	14/30281560 DC : 0