① Test instrument— Pulsatile-flow test machine

② Test basis—— ISO 5840-2: 2015 

The hemodynamic waveform simulated by the pulsatile tester should be capable of conforming to the waveform under physiological conditions in ISO 5840.

③ Test method—ISO 5840-2: 2015

The effective orifice area and total reflux percentage were measured at four different simulated cardiac outputs (e.g., 2 L/ min, 3.5 L/ min, 5 L/ min, and 7 L/ min) over the range of 2 L/ min–7 L/min at the same heart rate.

④ Test requirements—ISO 5840-2: 2015

The minimum performance requirements of ISO5840 were met with a heart rate = 70 beats/minute, simulated cardiac output = 5.0 L/ minute, and a forward flow time fraction of 35% under normotensive conditions.