ISO 80369-7 Luer Gauge Checklist

ISO 80369-7 Luer Gauge Checklist: Ensuring Compliance and Safety in Medical Connectors

Introduction

The ISO 80369-7 standard is a crucial guideline for the design and testing of Luer connectors used in medical applications. It replaces the previous ISO 594 standard, introducing stricter requirements to enhance safety and reduce the risk of misconnections. This checklist provides a comprehensive guide to ensure that Luer connectors meet the necessary specifications and perform reliably in clinical settings.

Dimensional Requirements

1. Male Luer Slip Connector (L1)

• Verify the dimensions and tolerances as specified in Figure B.1 and Table B.1 of the ISO 80369-7 standard.

• Ensure the maximum inside diameter at the tip of the male taper (through bore), Øf, is 2.900 mm.

2. Female Luer Slip Connector (L1)

• Check the dimensions against Figure B.2 and Table B.2.

• Confirm the compatibility with the male Luer Slip Connector using the specified reference cones.

3. Male Luer Lock Connector (L2)

• For connectors with a fixed collar, refer to Figure B.3 and Table B.3.

• For those with a floating or rotatable collar, use Figure B.4 and Table B.4.

4. Female Luer Lock Connector (L2)

• Verify dimensions using Figure B.5 and Table B.5 for standard connectors.

• For variant A, B, and C, check Figures B.6, B.7, and B.8, respectively.

Performance Testing

1. Leakage Tests

• Pressure Decay Leakage Test: Apply an axial force of 26.5N to 27.5N and a torque of 0.08Nm to 0.10Nm while rotating the connector. Pressurize the system to 300kPa to 330kPa and maintain for 15-20 seconds. The leakage should not exceed 0.005 Pa·m³/s.

• Positive Pressure Liquid Leakage Test: Apply an axial force of up to 27.5N and a torque of up to 0.12Nm. Maintain a pressure of 300kPa to 330kPa for 30-35 seconds. No significant leakage should be observed.

2. Stress Cracking Test

• Subject the connector to the stress conditions outlined in ISO 80369-20:2015, ensuring it meets the requirements of 6.1.1.

3. Resistance to Separation

• Axial Load Test: Apply an axial force of 23N to 25N for Luer Slip Connectors and 32N to 35N for Luer Lock Connectors. Maintain for 10-15 seconds to ensure the connector does not separate.

• Unscrewing Torque Test: For Luer Lock Connectors, apply a torque of 0.0198Nm to 0.0200Nm and maintain for 10-15 seconds.

4. Resistance to Overriding

• Test the connector using the appropriate gauges as described in Annex B of the ISO 80369-7 standard to ensure it does not override during assembly.

Material Specifications

• Ensure that the materials used for the Luer connectors have an elastic modulus greater than 700 MPa when tested in tension or flexure. This requirement ensures the durability and reliability of the connectors in various medical applications.

Conclusion

Adhering to the ISO 80369-7 Luer Gauge Checklist is essential for manufacturers and healthcare providers to ensure the safety and effectiveness of medical devices. By meeting the stringent dimensional and performance requirements, Luer connectors can significantly reduce the risk of misconnections and associated complications, thereby enhancing patient care.