Testing capability planning

ISO 80369 Medical Connector Testing Solutions

Plan or expand medical connector testing capability by matching the applicable standard, connector interface, reference connector or gauge, test method, fixture, measurement equipment and calibration or documentation requirements. Start with the engineering task, then define the equipment and supporting product scope.

Medical connector testing laboratory with reference products fixtures and measurement equipment
Configuration principle

Define the test requirement before selecting the equipment list.

Capability mapping

How a Connector Test Solution Is Defined

Equipment should not be selected in isolation. The applicable standard, connector side, reference interface, assembly condition and measured quantity determine the final configuration.

  1. 01Application
  2. 02Applicable standard
  3. 03Connector / DUT side
  4. 04Reference connector or gauge
  5. 05Test method
  6. 06Fixture / assembly condition
  7. 07Measurement equipment
  8. 08Calibration / verification
  9. 09Report & documentation
Application mapping

Standards & Application Coverage

Use the application and its applicable standard to identify the relevant reference interface and typical verification capability.

ApplicationApplicable standardTypical capability
Intravascular / HypodermicISO 80369-7Luer reference connectors, gauges, leakage, axial force and torque
EnteralISO 80369-3Reference connectors and applicable functional testing
Limb Cuff InflationIEC 80369-5Reference connectors and applicable verification
NeuraxialISO 80369-6Reference connectors and functional verification
RespiratoryISO 80369-2Connector verification for the applicable respiratory scope
Reservoir DeliveryISO 18250 seriesReference connectors and applicable verification methods
Configuration examples

Typical Solution Configurations

These examples are planning references, not fixed packages. Final configuration depends on the applicable standard, DUT side, connector interface and required test methods.

ISO 80369-7 Luer Verification

  • Reference connectors and Luer gauges
  • Controlled assembly and suitable fixtures
  • Leakage, axial separation and unscrewing torque
  • Calibration and documentation scope

Configuration depends on the male or female DUT, slip or lock interface and required verification methods.

Multi-Family ISO 80369 Laboratory

  • ISO 80369-3, IEC 80369-5, ISO 80369-6 and ISO 80369-7 coverage
  • Family-specific reference connectors or gauges
  • Shared method equipment only where technically applicable
  • Fixtures, adapters and verification records

Each connector family is configured separately; one equipment list does not automatically satisfy every ISO 80369 application part.

Production QC Setup

  • Gauges and selected reference connectors
  • Selected leakage or mechanical checks
  • Repeatable fixtures and controlled setup conditions
  • Calibration control and periodic verification records

The inspection plan should match the product, lot controls, measured characteristics and release requirements.

Technical inquiry

Technical Inquiry and Configuration Support

To prepare a technically appropriate configuration, provide as much of the following information as available. Unknown items can be reviewed with KingPo engineering before quotation.

  • Standard
  • Application
  • Connector family
  • DUT side
  • Male / female
  • Slip / lock
  • Figure / Annex
  • Required test methods
  • Reference connectors required
  • Gauge requirement
  • Existing equipment
  • Calibration requirement
  • Documentation requirement
  • Quantity