Infusion Set Positive Pressure Leakage Tester | ASTM ISO Testing Machine
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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 |
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