1

Scope

1.1

This International Standard specifies tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve substitutes of all types, and of the materials and compo nents of which they are made.

1.2

Requirements are provided for preclinical in vivo evaluation, for clinical evaluation, and for reporting the results of all types of testing and evaluation covered in this International Standard. These requirements do not purport to comprise a complete test programme.

1.3

Specifications are also given for packaging and labelling of heart valve substitutes.

1.4

This International Standard is not applicable to heart valve substitutes comprised in whole or in part of human tissue.

NOTE - A rationale for the provisions of this International Standard is given in annex A.