Infusion Set Positive Pressure Leakage Tester
The Infusion Set Positive Pressure Leakage Tester is a dedicated testing instrument developed in accordance with relevant national medical device standards for evaluating the positive pressure leakage performance of infusion sets. The system integrates intelligent control, force measurement, displacement measurement, and data output functions, providing a stable and standardized solution for leakage testing. With a user-friendly interface and clear parameter display, the tester ensures efficient and repeatable quality inspection for disposable infusion devices.
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 |
Features
Standard-oriented design
Developed specifically to meet the positive pressure leakage test requirements defined in national medical device standards.
Integrated intelligent control system
The built-in CPU, mainboard, LCD display, and keyboard enable stable control and precise parameter setting.
Clear and intuitive operation
Full-window Chinese interface with menu-driven operation allows straightforward use without specialized training.
Stable pressure control and monitoring
Adjustable positive pressure output with digital display ensures consistent test conditions and reliable leakage detection.
Compact and functional structure
Combines control, measurement, and data output functions in a single, practical testing unit.
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.
Maintenance Information
Regularly inspect pressure connections and sealing components to prevent leakage.
Keep the display screen and control panel clean and free from moisture.
Verify pressure accuracy periodically to maintain compliance with test requirements.
Ensure the power supply grounding is reliable before each operation.
Store the instrument in a clean, dry environment when not in use.
FAQ
1. What is the core advantage of this product?
Its main advantage lies in standardized positive pressure leakage testing specifically designed for disposable infusion sets in accordance with medical device regulations.
2. Are the test results reliable?
Yes. Stable pressure control, accurate timing, and defined pressure-holding requirements ensure consistent and repeatable test results.
3. Which international or industry standards does it comply with?
The tester complies with GB 8368-2018 for disposable gravity-type infusion sets.
4. Why is this product important?
Positive pressure leakage testing is critical for ensuring the safety and reliability of infusion devices, directly impacting patient safety during clinical use.
5. Which fields is this product suitable for?
It is suitable for medical device manufacturing, quality inspection laboratories, regulatory testing institutions, and product development environments for infusion devices.
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