1 Scope
2 Normative references
3 Definitions
4 Valve description
5 Material, component and valve assembly testing
6 Hydrodynamic testing
7 Durability testing
8 Preclinical in vivo evaluation
9 Clinical evaluation
10 Packaging, labelling and instructions
Annexes
A Rationale for the provisions of this International
Standard
B Materials related to heart valve substitutes
C Physical and material properties of heart valve
substitutes and their components
D Standards applicable to testing of materials and
components of heart valve substitutes
E Definitions of components of a heart valve substitute
F Valve description