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Glossary Term
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ISO 80369 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications)

Definition

ISO 80369 is an international standard that specifies the dimensions, design, and performance requirements for small-bore connectors used in medical devices. These connectors are designed to minimize the risk of accidental misconnections between devices delivering different types of liquids or gases, ensuring patient safety and reducing adverse events.

Relevance to the MedTech Industry

ISO 80369 ensures the safe and reliable connection of medical devices used for critical functions, such as intravenous therapy, respiratory support, and enteral feeding. By standardizing connector designs, the standard helps prevent potentially life-threatening misconnections, improving patient outcomes and reducing liability risks for manufacturers and healthcare providers.

Additional Information & Related Terms

Key Sections of ISO 80369

  1. ISO 80369-1: General Requirements

    • Provides overarching requirements for small-bore connectors used in healthcare applications.

  2. ISO 80369-2 to ISO 80369-7

    • Specifies connectors for specific applications, including:

      • ISO 80369-2: Breathing systems and driving gases.

      • ISO 80369-3: Enteral feeding.

      • ISO 80369-6: Neuraxial applications.

      • ISO 80369-7: Intravascular or hypodermic use.

  3. Performance Testing

    • Includes mechanical, leakage, and usability testing to ensure connectors perform reliably under clinical conditions.

  4. Prevention of Misconnections

    • Specifies unique designs and geometries for each application to avoid accidental cross-connections between systems.


Examples of Applications

  • Enteral Feeding Systems: ISO 80369-3 connectors prevent misconnections between enteral feeding and intravenous lines.

  • Breathing Systems: ISO 80369-2 connectors ensure compatibility and safety in respiratory therapy equipment.

  • Intravascular Systems: ISO 80369-7 connectors standardize designs for intravenous and hypodermic devices to ensure safe medication delivery.

Related Terms

  • Regulatory Compliance: ISO 80369 compliance is critical for meeting FDA, CE, and other global regulatory standards.

  • Usability Engineering (ISO 62366): Ensures connectors are designed for intuitive and error-free use.

  • ISO 13485: Quality management system requirements, often incorporating ISO 80369 for device compatibility and safety.

  • Sterilization Validation (ISO 11137): Ensures that small-bore connectors maintain sterility where required.

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