Standard name: Small-bore connectors for liquids and gases in healthcare applications.
Applicable medical devices:
This standard applies to any small-bore connectors where their end-use is either part of or form connections in:
- Intravascular devices
- Hypodermic applications
- Breathing systems and driving gas devices
- Enteral and gastric applications (such as drainage connections and enteral feeding sets)
- Urethral and urinary applications (such as collecting systems and catheters)
- Limb cuff inflation devices
- Neuraxial devices
Testing capabilities to ISO 80369 include:
- Dimensional requirements for luer connectors
- Fluid leakage by pressure decay using specific reference fitting
- Falling drop positive pressure liquid leakage
- Subastmospheric-pressure air leakage
- Stress cracking – with reference fitting
- Resistance to separation – from axial load/unscrewing
- Resistance to overriding
Standard Sections:
- ISO 80369-1:2010 General requirements
- ISO 80369-3:2016 Connectors for entral applications
- ISO 80369-5:2016 Connectors for limb cuff inflation applications
- ISO 80369-6:2016 Connectors for neuraxial applications
- ISO 80369-7:2016 Connectors with 6% (Luer) taper for intravascular or hypodermic application
- ISO 80369-20:2015 Common test methods
This standard does not specify requirements for the medical devices which uses these connectors as part of their device. ISO 80369-20 section of this standard contains the common test methods to support the functional requirements for small-bore connectors. The other parts document the design and dimensions of small-bore connectors according to their specific application categories and provide a framework for testing connectors of different medical applications against each other to ensure non-interconnectability. ISO 80369-2 section 'Connectors for breathing systems and driving gases applications' and ISO 80369-4 section 'Connectors for urethral and urinary applications' are still under development by the International Organization for Standarization.
Custom Testing
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of EN ISO 80369.
