ISO 80369-1

ISO 80369 applies to small-bore connectors used in medical devices or accessories intended for patient-side care. The core of these standards are new connector types that minimize the possibility of interconnections. This test standard specifies the requirements for small-bore connectors which convey liquids or gases medical applications.

Axial motion is used to try to connect luer with a max force not to exceed 70N. Then the test machine must apply a load at a rate of 10N/sec. Then torque not exceeding 0.12 N-m for no more than 90 degrees is applied counterclockwise. Next, the maximum axial force and max torque is held at least 10 sec. Then the connection is disengaged with an axial force less than .02N. This test requires a small test machine capable of combined axial and torsional motion and loading.

ISO 80369 includes sections on:

  • 80369-1 General Requirements
  • 80369-2 Connectors for breathing systems and driving gases applications
  • 80369-3 Connectors for enteral applications
  • 80369-4 Connectors for urethral and urinary applications
  • 80369-5 Connectors for limb cuff inflation applications
  • 80369-6 Connectors for neuraxial applications
  • 80369-7 Connectors for intravascular or hypodermic applications
  • 80369-20 Test methods for each application

How does ISO 80369 improve patient safety?

ISO 80369 attempts to ensure that luers intended for different medical materials and different geometries are incompatible and cannot be accidentally connected. The test is aimed at ensuring that incompatible luers will NOT connect together.

There are ISO 80369 connector standards for each of five major types of fluid or gas delivery systems used in direct patient care.

Equipment Required

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Recommended Test Machine for ISO 80369