Luer Testing Services

What are luer connectors?

Luer connectors are a standardized interlocking system of tapered small-bore connectors used in the medical device industry for intravascular and hypodermic applications on devices such as syringes, catheters and IV sets.

What are the luer testing standards?

The primary guidance standard for luer testing is ISO 80369-7 for small-bore connectors for liquids and gases in healthcare applications. It supersedes ISO 594-1 and ISO 594-2.

STERIS offers a complete range of tests for luer connectors in accordance with ISO 80369-7.

Why is luer testing performed?

Luer connectors are used to form secure leak-proof connections for the transfer of liquids and gases required for patient care. Luer testing is performed to ensure that these connectors are fit for use and safe.

ISO 80369-7 outlines the performance criteria for these connections and ISO 80369-20 outlines the test methods used to ensure that these criteria are met. Through luer testing, manufacturers can ensure the reliability of these connections to prevent disruptions or misconnections of product used in a healthcare setting.

Luer testing services from STERIS include:

  • Dimensional analysis
  • Performance tests (ISO 80369-20):
    • 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)

Dimensional analysis (ISO 80369-7 Annex B)

The dimensional requirements of luer connectors can be found detailed in ISO 80369-7 Annex B. These dimensional requirements were introduced to ensure that luer connectors do not misconnect with other small-bore connectors in clinical use. STERIS can offer guidance and manage the measurement of luer connectors against their applicable dimensional requirements.

Technical support

STERIS also offers technical support, including:

  • Protocol development
  • Early-stage design support
  • CAD compliance
  • Material assessment
  • Training

Related content:

TechTalk: Design requirements for luer connectors
TechTip: From ISO 594 to ISO 80369: Making sense of the latest luer requirements
TechTalk: Testing validation TechTalk webinar

Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.