Medical infusion set leakage testing equipment
Whats/App: +86 156 1874 6768
Web: standard-groups.com
Application
This tester is designed for positive pressure leakage testing of medical infusion devices during quality control and compliance verification.
Typical application scenarios include:
Positive pressure leakage testing of disposable infusion sets
Quality inspection of gravity-type infusion devices
Incoming inspection and batch testing in medical device manufacturing
Type testing and routine verification in testing laboratories
Compliance testing during product development and certification
Applicable test products include disposable infusion sets and related fluid delivery components.
Standards
The Infusion Set Positive Pressure Leakage Tester complies with the following medical device standard:
GB 8368-2018 (Disposable infusion sets for single use, gravity feed)
Parameters
| Parameter | Specification |
|---|---|
| Positive Pressure Output Range | 120 kPa–160 kPa (adjustable), LED digital display, accuracy within ±5% |
| Positive Pressure Holding Performance | Pressure drop shall not exceed 1 kPa within 3 minutes |
| Test Duration | 1 s–60 s (adjustable), LED digital display, accuracy within ±1 s |
| Pressure Range | 0–69 kPa |
| Time Setting Range | 0–999 s |
| Power Consumption | 200 VA |
| Display Type | 320 × 240 monochrome LCD, full Chinese window interface |
| Control Method | Keyboard control for menu navigation and on-screen keypad operation |
| Operating Temperature | 5–40 °C |
| Relative Humidity | 45–80% |
| Power Supply Voltage | 220 V ±22 V |
| Power Frequency | 50 Hz ±1 Hz |
| Equipment Classification | Class I, Type B |
Accessories
Power cable
Built-in printer
Drain outlet connector
Operation manual
Test Procedures
Place the instrument horizontally on a stable testing bench.
Install the test specimen securely onto the drain outlet connector.
Connect the power plug to the distribution board, ensuring reliable grounding of the power socket.
Power on the instrument and set the required positive pressure and test duration via the control panel.
Start the test and observe pressure stability during the test period.
Record or print the test results as required after test completion.
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