What are the key differences between ISO 80369-7 and ISO 594?

The ISO 80369-7 standard, which replaced ISO 594, introduces several key differences and improvements to ensure better safety and performance of luer connectors used in medical applications. Here are the main differences:

Dimensional and Mechanical Specifications

• Stricter Dimensions: ISO 80369-7 has more precise dimensional requirements compared to ISO 594. This includes more detailed specifications for the taper angle, thread dimensions, and overall connector geometry.

• Unified Requirements: The new standard combines the separate sets of dimensions for semi-rigid and rigid materials into one unified set, simplifying compliance requirements.

Material Requirements

• Elastic Modulus: ISO 80369-7 requires that the material used for luer connectors must have an elastic modulus greater than 700 MPa when tested in tension or flexure. This ensures that the connectors can withstand mechanical stress without deformation.

Testing and Performance

• Testing Against Reference Connectors: ISO 80369-7 requires testing against both luer slip and luer lock reference connectors, ensuring that connectors meet performance standards in both configurations.

• Modified Assembly and Test Procedures: The new standard includes modifications to assembly and test procedures to better align with modern testing equipment and methods. This ensures more reliable and consistent performance testing.

• Variable Testing Guidance: ISO 80369-7 provides guidance for performing variable tests, which can help reduce the number of samples needed while maintaining statistical confidence.

Non-Interconnectability

• Prevention of Misconnections: One of the primary goals of ISO 80369-7 is to prevent misconnections between different medical devices. This is achieved through more stringent dimensional and design requirements that make it difficult to connect incompatible devices.

Backward Compatibility

• Compatibility with ISO 594: While ISO 80369-7 is designed to be backward compatible with ISO 594, connectors that only meet the performance requirements of ISO 594 may not be fully compliant with ISO 80369-7. This is because ISO 80369-7 requires full compliance with material, dimensional, and performance specifications.

These changes in ISO 80369-7 aim to improve patient safety by reducing the risk of misconnections and ensuring that luer connectors perform reliably in medical applications.