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