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ISO 8536 infusion set positive pressure leakage tester

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Whats/App: +86 156 1874 6768

Web: standard-groups.com

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.

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

ParameterSpecification
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


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