Parameters and methods for testing artificial heart valves.

Abstract

The report describes the development of heart valve test standards. The aim is comprehensive quality assurance by in vitro tests. The project includes three test fields: general basis, development and definition of test methods and test devices and comparative in vitro assessment of valves for the definition of minimum requirements. A preliminary list of test parameters and test steps has been defined: geometrical, flow, deformation, force, and conditioning parameters. A system of geometrical parameters has been developed for standardized aortic models. Geometrical parameters of 31 valves of six types and different sizes underline a close correlation between geometrical and hemodynamic parameters. The relative ostium cross-section Ae/AT increases with valve size and lies between 0.3 and 0.5. Two new measurement devices with quasi-steady flow are proposed as quick testers for leakage flow and pressure loss.