Intravascular catheters-single-use sterile catheters
Test of flow and pressure in power injection (only applicable to power injection products)
1 principle
The catheter is connected to the actual or simulated connecting pipeline through the catheter base or its adjacent end, and the connecting pipeline is then connected to a constant pressure device filled with injection or simulated injection. The pressure of the pressure source is set to the recommended syringe pressure limit of the product, and the system flow rate should be measured by a mass balance or other suitable methods. The peak pressure at the catheter inlet should also be recorded by an on-line pressure sensor.
2 instruments
2.1 Constant pressure device, which provides simulated injection to the catheter and catheter connector assembly, while keeping the pressure within ±5% of the clinical use pressure and the temperature within ±2°C of the required temperature during the measurement process.
2.2 Injection or simulated injection, (for example, a mixture of glycerol and water or others) mix so that the dynamic viscosity (kinematic viscosity/fluid density) of the target injection is within the required ±5% range.
2.3 The actual or simulated connecting pipe, the inner diameter and length should be in line with clinical use.
2.4 On-line pressure sensor and data logger, connect the end of the analog connecting pipe and the catheter base.
Test of flow and pressure in power injection (only applicable to power injection products)
1 principle
The catheter is connected to the actual or simulated connecting pipeline through the catheter base or its adjacent end, and the connecting pipeline is then connected to a constant pressure device filled with injection or simulated injection. The pressure of the pressure source is set to the recommended syringe pressure limit of the product, and the system flow rate should be measured by a mass balance or other suitable methods. The peak pressure at the catheter inlet should also be recorded by an on-line pressure sensor.
2 instruments
2.1 Constant pressure device, which provides simulated injection to the catheter and catheter connector assembly, while keeping the pressure within ±5% of the clinical use pressure and the temperature within ±2°C of the required temperature during the measurement process.
2.2 Injection or simulated injection, (for example, a mixture of glycerol and water or others) mix so that the dynamic viscosity (kinematic viscosity/fluid density) of the target injection is within the required ±5% range.
2.3 The actual or simulated connecting pipe, the inner diameter and length should be in line with clinical use.
2.4 On-line pressure sensor and data logger, connect the end of the analog connecting pipe and the catheter base.
2.5 System flow measuring devices, with an accuracy of ±2%, such as mass balances and timers or flow meters.
