ISO 18250-1 Subatmospheric Pressure Air Leakage Tester

The ISO 18250-1 Air Leakage Tester is used to assess the sealing performance of small bore connectors when subjected to sub-atmospheric pressure, simulating real aspiration conditions. By applying a controlled vacuum and monitoring pressure changes over time, the tester determines whether the connector meets the leakage limits specified in ISO 18250-1 and ISO 80369-20 Annex D.

The instrument features an integrated PLC system and a user-friendly 7-inch touch screen. Test results are automatically calculated and can be printed directly, improving testing efficiency and data traceability for quality control and compliance purposes.

Technical Parameters

Testing Principle

The ISO 18250-1 Air Leakage Tester evaluates the sealing performance of small bore connector assemblies by applying a controlled sub-atmospheric pressure (vacuum) to the system and monitoring the rate of pressure change over a specified period.

During the test, a stable vacuum is first established within the connector assembly. The system then continuously measures any pressure rise over time. A significant increase in pressure indicates air ingress, which reflects inadequate sealing. This method effectively simulates real-world aspiration conditions and provides objective data to verify whether the connector meets the leakage requirements specified in ISO 18250-1 and ISO 80369-20 Annex D.

Common Error Mitigation

To obtain accurate and reliable test results, the following practices are recommended:

• Ensure connector assemblies are properly connected and sealed before testing.
• Verify that the vacuum source and pressure sensor are functioning correctly.
• Set appropriate test time and pressure parameters according to the relevant standard.
• Regularly calibrate the pressure sensor to maintain measurement accuracy.
• Operate the equipment in a stable laboratory environment to minimize external interference.

Applications and Use Cases

The ISO 18250-1 Air Leakage Tester is mainly used by medical device manufacturers and testing laboratories for quality control and compliance verification of small bore connectors.

Typical applications include:

• Air leakage testing of medical connectors during aspiration
• Compliance testing according to ISO 18250-1 and ISO 80369-20 Annex D
• Quality control of infusion and transfusion connectors
• R&D verification of new small bore connector designs
• Routine batch testing in medical connector production

Key Advantages

The ISO 18250-1 Air Leakage Tester provides a reliable and standardized solution for evaluating subatmospheric pressure air leakage in small bore connectors, fully complying with ISO 18250-1 and ISO 80369-20 Annex D requirements.

Its PLC control system with a 7-inch color touch screen simplifies operation, while the built-in thermal printer enables automatic result output, significantly improving testing efficiency and data traceability. With high measurement accuracy of ±0.25% FS and real-time pressure curve display, the tester delivers precise and visual results.

The compact benchtop design makes it easy to integrate into laboratory workflows, making it well-suited for both routine quality control and product development of medical connectors.