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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