YY/T 1564-2017Cardiovascular implants-Pulmonary valve conduit -Pulsatile flow test methods (English PDF)

4.1 Test system

4.1.1 in vitro pulsatile flow test system should be able to produce similar physiological conditions pulsation, the physiological conditions should be consistent with Table 1, Table 2 Claim.

4.1.2 In vitro pulsatile flow performance test The performance of the system can be confirmed by reference to the valve.

4.1.3 In vitro pulsatile flow performance test system should be able to test the pressure over time, the volume flow rate, velocity field and turbulent shear stress field.

4.1.4 In vitro pulsatile flow performance test system repeatability should be evaluated.

4.1.5 in vitro pulsatile flow test system geometry and mechanical properties should be able to represent the expected site of implantation.

4.1.6 Testers should be able to observe and photograph blood inflow and outflow during all phases of circulation.

4.1.7 The pressure measurement system shall have a natural frequency of at least 50 times the test cycle rate and a measurement accuracy of ± 0.26 kPa (± 2 mmHg) Range.

4.1.8 Flow measurement system measurement accuracy should be within ± 2mL range.

4.1.9 The minimum measurement accuracy of all other measuring equipment shall be within ± 5% of the full scale reading.

4.2 Test conditions

According to the population of pulmonary artery valves, select the appropriate test conditions in Table 1 and Table 2.