① Test instrument—fatigue test machine

② Test method 

The time in which each valve achieves the target transvalvular pressure difference (aortic valve 100mmhg, mitral valve 120mmhg) in the test should account for more than 5% of its time in each open and close cycle, and such kind of cycles should account for more than 95% of the entire test cycles.

③ Test basis

Bioprosthetic valves should be capable of withstanding at least 200 million cycles and maintain intact structural properties in the condition of the transvalvular pressure difference (aortic valve 100mmhg, mitral valve 120mmhg), under normotensive conditions as specified in ISO 5840-2:2015.

④ Evaluation method

The test samples were subjected to pulsatile flow testing after every 5*106 cycles to evaluate their performance. The valve should still maintain its basic performance after 200 million fatigue cycles.