ISO 80369-20 Medical Small Bore Connector Test Equipment

ISO 80369-20 Medical Small Bore Connector Test Equipment

The ISO 80369-20 Medical Small Bore Connector Test Equipment is a comprehensive test system designed to evaluate the performance of small-bore connectors used in medical applications. It supports Annex B (pressure decay / subatmospheric-pressure air leakage) and Annex C (positive-pressure liquid leakage) test methods, and includes the Connector Assembly Device for Annexes B through I of ISO 80369-20 and ISO 18250-1.

Technical Parameters

Professional Construction & Technical Precision

The Medical Small Bore Connector Test Equipment is built with high-precision force sensors, pressure transducers, and flow meters to ensure accurate and repeatable test results. The system features a modular design that allows flexible configuration for different connector types and test methods as required by ISO 80369-20.

The PLC touchscreen controller enables programmable test sequences, real-time data monitoring, and automatic data logging. Robust mechanical fixtures and safety interlocks ensure reliable operation and operator safety during testing. The equipment is designed for long-term laboratory use with minimal maintenance requirements.

Testing Principle

The Medical Small Bore Connector Test Equipment evaluates the functional performance of small-bore connectors according to ISO 80369-20. The connector under test is mounted on precision fixtures, and various mechanical and fluidic tests are performed, including:

• Leakage Testing: Applying internal pressure or vacuum to detect liquid or gas leakage.
• Separation Force Testing: Measuring the axial force required to separate the connector.
• Resistance to Separation: Evaluating the connector’s ability to resist unintentional disconnection.
• Flow Rate Testing: Verifying flow characteristics through the connector.

All test parameters are precisely controlled and recorded, providing objective data to verify compliance with the standard and ensure the safety and reliability of medical connectors in clinical use.

Common Error Mitigation & Safety Guidelines

To achieve accurate and repeatable test results while ensuring safe operation, the following practices are strongly recommended:

• Verify correct connector type and test method selection before each series.
• Ensure connectors are properly mounted and aligned in the test fixtures.
• Use clean, filtered test media (air or liquid) to avoid contamination.
• Calibrate force sensors, pressure transducers, and flow meters at recommended intervals.
• Record all critical parameters—including force, pressure, flow rate, duration, and observations—for complete traceability and regulatory compliance.

Safety Notes

• Follow proper procedures when handling pressurized systems.
• Do not exceed the rated pressure or force limits of the equipment.
• Only qualified personnel should operate or maintain the equipment.

• User-Friendly Design: Compact, durable, and requires no external power or compressed air, ensuring ease of use in laboratory settings.
• High Throughput: Semi-automatic testing capabilities increase efficiency, reducing test times while maintaining traceability and accuracy

Primary Use Cases & Business Value

The Medical Small Bore Connector Test Equipment delivers significant value by enabling comprehensive validation of small-bore connector performance, helping manufacturers meet strict regulatory requirements, reduce the risk of misconnections, and ensure patient safety. It supports faster product development, reliable compliance documentation, and improved quality control for medical device manufacturers.

Industrial Applications & Lab Scenarios

• Medical Device Manufacturers — ISO 80369-20 compliance testing for infusion sets, catheters, and respiratory equipment
• Connector and Tubing Producers — Performance validation of Luer, NRFit, and other small-bore connectors
• Third-Party Testing Laboratories — ISO 80369-20 formal compliance and type-approval testing
• Quality Assurance and R&D Departments — Design verification and batch release testing
• Hospitals and Clinical Engineering — Incoming inspection of medical connectors

Strategic Procurement Advantages & Global Support

• Perform multiple ISO 80369-20 test methods in one integrated system
• Achieve high accuracy with precision force, pressure, and flow measurement
• Benefit from flexible fixtures for various connector types and programmable test cycles
• Ensure full compliance with international medical connector safety standards
• Receive responsive technical support, calibration services, and full documentation from an experienced manufacturer