Testing of heart v
Testing of heart valve substitutes
All heart valve substitutes to be tested shall be of the quality suitable for human implantation, before testing , each heart valve substitute shall have been sterilized by the process oriented to be used . In the case of heart valve substitute that may be resterilized by the user , it shall also be subjected to the recommended maximum number of resterilization cycles using the method stated by the manufacture to be the worst case procedure . (127)
Mechanical testing of a heart valve substitute for the following procedures is at least three heart valve substitutes of each of the largest medium and smallest size tissue annulus diameter, plus at least one valve of each intermediate size shall be tested.
1-sewing ring tear-off and tear-out forces principle
The aim of this test procedure is to generate information on the sewing ring such that it satisfactorily withstands the force
specified by the manufacture , separating it from other parts of the valve .