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Appendix 2 Flow Accuracy Test Method for Infusion Pump
1. Test method: gravimetric method
2. Principle
Gravimetric method uses electronic balance. Connect calibration system as per diagram 2-1. Put certain
volume of fluid into container (Container should add lid. If without lid it should add certain amount of
paraffin oil to prevent evaporation). Injection needle should be under surface of fluid. Use container to
collect the total output volume from infusion pump during test period. Then calculate the differences
between preset volume and actual volume flowing out (weight on electronic balance)
3. Test Environment
3.1 Temperature: 20±2°C
3.2 Relative humidity: 60±15%
3.3 Atmospheric pressure: 860hpa~1060hpa (645mmHg~795mmHg) (note:1 standard atmospheric
pressure:760mmHg)
4. Test instruments and reagents:
4.1. Calibrated electronic balance (Requires precision to more than three decimal places)
4.2 Injection needle (18G,1.2mm)
4.3 Infusion set
4.4 Connecting components (connecting infusion tube and needle)
4.5 container ( anti-volatile paraffin oil)
5 Test procedures
5.1 Connect infusion pump, infusion set, electronic balance and container.
5.2 The balance is placed in suitable fixed position; the container on the balance. Put certain amount of
water and certain drops of Anti-volatile oil to container (Record the reading of electronic balance)
5.3 Connect a brand new infusion set as per instruction, immerse injection needle below the surface of
fluid in container and keep hanging.
5.4 The infusion pump is placed in proper position. Ensure infusion pump input terminal and the container
fluid surface at the same level height. Turn on the machine.
5.5 Fix the pipe and ensure no deformation of tubing due to movement or other reasons during testing.
5.6 Enter calibration interface (under system settings)
Press START key, the Infusion Pump shall start operation at 150ml/h. After it finishes VTBI (10ml),
