Testing of flow rate and pressure during sterile catheter power injection

Intravascular catheter - Single-use sterile catheter
Flow and pressure testing during power injection (applicable only to products for power injection)
1 Principle
Connect the catheter to the actual or simulated connection tubing through the catheter holder or its adjacent end. The connection tubing is then connected to a constant-pressure device filled with the injection fluid or a simulated injection fluid. The pressure source is set to the recommended syringe pressure limit for the product, and the system flow should be measured by a mass balance or other appropriate method. The peak pressure at the catheter inlet should also be recorded by an online pressure sensor.
2 Equipment
2.1 Constant pressure device, providing simulated injection fluid to the catheter and catheter connector assembly, while maintaining the pressure within 5% of the clinical used pressure during the measurement process, and the temperature within ±2°C of the required temperature.
2.2 Injection fluid or simulated injection fluid (such as a mixture of glycerol and water or others), mixed to achieve the target injection fluid's dynamic viscosity (viscosity/mass density) within ±5% of the required range.
2.3 Actual or simulated connection tubing, with an inner diameter and length that comply with clinical use.
2.4 Online pressure sensor and data recorder, connecting the end of the simulated connection tubing and the catheter holder.
2.5 System flow measurement device, with an accuracy of ±2%, such as a mass balance and timer or flow meter. 
LFY-710C Medical Catheter Power Injection Flow and Pressure Tester is a device suitable for testing the steady flow rate of the injection fluid passing through the vascular internal catheter under a constant power injection pressure, as well as the pressure at the catheter inlet. It complies with the standard YY 0285.1-2017 "Single-use Sterile Catheters for Vascular Internal Use - Part 1: General Requirements".