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Connector Testing

 

ISO 80369 is a series of standards developed to ensure the safety and compatibility of small- bore connectors used in healthcare applications. These connectors are crucial for various medical devices, such as syringes, catheters, and infusion tubes, in order to prevent misconnections and ensure secure connections for liquids and gases.

The standard is divided into several parts, each addressing different types of connectors and their specific applications. SMTL use the test methods listed in ISO 80369-20 General Test Methods and can currently test to the following parts of the standard:

  • ISO 80369-3: Connectors for enteral applications.
  • ISO 80369-6: Connectors for neuraxial applications.
  • ISO 80369-7: Connectors for intravascular or hypodermic applications (Luer connectors)

ISO 80369-20 encompasses several test methods covering assessments of leakage, resistance to separation, and durability under stress. The testing undertaken by SMTL includes the following performance requirements:

  • Fluid leakage by pressure decay (Annex B)
  • Falling drop positive pressure liquid leakage (Annex C)
  • Sub-atmospheric pressure air leakage test (Annex D)
  • Stress cracking (Annex E)
  • Resistance to separation from axial load (Annex F)
  • Resistance to separation from unscrewing (Annex G)
  • Resistance to overriding (Annex H)
  • Disconnection by unscrewing (Annex I)

connecter testing
 

Testing of connectors is intended to be performed against respective calibrated reference connectors manufactured to the fine tolerances stipulated in each of the standards.

However, in many instances, our clients require testing which is beyond the test method parameters set out in a standard. For example, SMTL have recently reviewed the performance of needle-free connectors when assembled with glass syringes.

Alongside our standard testing services, our expert team can develop a custom testing program to meet your specific testing requirements and resolve any design or functionality issues you might have. To discuss a testing programme please contact us smtl.info@wales.nhs.uk

 

Relevant Standards

  • ISO 80369-1: General requirements
  • ISO 80369-3: Connectors for enteral applications
  • ISO 80369-6: Connectors for neuraxial applications
  • ISO 80369-7: Connectors for intravascular or hypodermic applications
  • ISO 80369-20: General test methods