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ISO 80369 Part 7 and Part 20 Luer System/Luer Lock Connections

Based on the ISO 80369 standard, various tests are used to test a Luer system or Luer lock connector for stability—ZwickRoell offers the right testing system.

Details on the Luer system or Luer lock connection

  • The Luer cone is a standardized connector system used in tube systems in the medical industry. It is used with cannulas, syringes, catheters, three-way stopcocks, and infusion tubes. The seal is achieved through a conical fitting, called a Luer cone. The Luer lock connector also has a threaded sleeve to achieve a tight connection so fluids cannot escape.
  • For quality control of these components, a materials testing machine with superimposed torsion drive is used.
  • Based on the ISO 80369 standard, various tests are used to test a Luer system or Luer lock connector for stability. It is possible to easily determine torques under static axial load with the superimposed axial/torsion drive of a zwickiLine torsion materials testing machine.
  • With the integrated compression fixture, the seal integrity tests required by the standard can be performed.

Luer lock testing: Revisions to ISO 80396 require reliable testing solution to ensure data integrity

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Related products ISO 80369

Traceable, tamper-proof test results in accordance with FDA 21 CFR Part 11

Traceable tamper-proof test results
  • Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
  • With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
  • Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
  • Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
  • ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
  • testXpert III logs all test and system related actions and settings and can therefore always answer the question “When does who do what, why and who is responsible?” 

Learn more about the testXpert III option

Name Type Size Download
  • Industry brochure: Medical PDF 6 MB