Torque of rotate
2-Torque of rotate table valves
the aim of this test is to provide information on the torque required to rotate the valve with its sewing ring of appropriate procedure . The test shall be carried out for the worst case (dry or wet) as specified by the manufacturer.
3- Static pressure testing
The aim of this test procedure is to provide information about
the static pressure the heart valve substitute can withstand without impairment of function .
The aim of test procedure is to examine stiffness occluder sticking or dislodging the valves shall be .
procedure and results
the manufactures shall document the testing procedure and
describe the different design related problems that could occur when the heart valve substitute is submitted to given range of force.
The aim of the test procedure is to generate invitro information on the fluid mechanical performance of the heart valve substitute under conditions of steady and pulsatile flow testing .
The aim is to provide information on durability and failure modes experienced invitro compared to a valve with well –established acceptable clinical performance . All other measuring equipment used shall have measurement accuracy of 5% of the full scale reading .
The test fluid shall be appropriate for the conditions set by the test .Polymeric leaflet heart valve substitutes and other shall be tested at 37ºc unless it can be demonstrated that testing at other temperatures do not influence the test results.
Most mechanical biological heart valve substitutes may be tested at ambient room temperature
In vivo evaluation
The aim of invivo assessment is to provide data pertaining to the clinical performance and unanticipated side effects of a heart valve substitute invivo