This document specifies the test method for in vitro fluid dynamics of transcatheter implantable prosthetic heart valves. This document applies to transcatheter implantable artificial heart valves, which mainly include: artificial heart valves for the left heart aortic valve and mitral valve, and artificial heart valves for the right heart pulmonary valve and tricuspid valve. The support structure of such a valve may be made of metallic materials and/or polymeric materials, and the leaflets may be made of animal-derived tissue and/or non-animal-derived materials.
T/CSBME 045-2022 history
2022T/CSBME 045-2022 Standard test methods for hydrodynamic performance of heart valve substitutes implanted by transcatheter techniques