ISO80369-20 Annex F Axial Load Tester 0-500N for Medical Connectors

The ISO 80369-20 Annex F Axial Load Tester is designed for mechanical separation testing of medical small-bore connector assemblies. Unlike leakage testing equipment, this tester focuses on the mechanical retention of the connector interface when an axial load is applied.

For Luer connectors and other medical small-bore connectors, axial load testing helps laboratories and manufacturers evaluate whether a connector assembly may separate, slip or fail under the specified loading condition. The tester is suitable for R&D verification, incoming inspection, production quality control and laboratory test projects related to ISO 80369-20 Annex F.

Because connector geometry, mating direction and fixture design can affect the test result, the fixture and sample holding method should be confirmed according to the customer’s actual connector sample and test procedure.

What Annex F Axial Load Testing Verifies

ISO 80369-20 Annex F axial load testing is used to evaluate the mechanical connection strength of medical small-bore connector assemblies under axial force.

Typical verification purposes include:

• Checking whether a connector assembly separates under axial load
• Evaluating mechanical retention of Luer slip or Luer lock connector samples
• Supporting connector design verification during R&D
• Supporting incoming inspection of connector components
• Supporting production QC for medical connector assemblies
• Preparing samples for ISO 80369 related performance evaluation

This tester does not apply liquid pressure or air leakage conditions. If the project requires leakage testing, the ISO 80369-20 Liquid Leakage Tester or Annex D Air Leakage Tester should be selected instead.

Testing Principle

During the test, the connector sample is installed in a suitable fixture or connector holding configuration. The tester applies axial force along the connector mating direction according to the required test method. The system controls the loading process and records the force, time or separation result depending on the selected configuration.

The key points of Annex F related testing are the loading direction, fixture alignment and sample holding method. Poor alignment, unsuitable clamping or incorrect fixture design may affect the test result. For this reason, the fixture should be selected or customized according to the sample type, connector gender and mating structure.

For Luer connector samples, appropriate ISO 80369-7 reference connectors or gauges may also be required depending on the test setup and sample verification plan.

Technical Specifications

Fixture and Sample Holding

Fixture selection is a critical part of ISO 80369-20 Annex F axial load testing. The fixture must hold the connector sample securely while allowing the load to be applied along the correct axis.

Typical fixture considerations include:

• Connector type: Luer slip, Luer lock or other small-bore connector
• Sample gender: male connector, female connector or assembled connector
• Mating structure and loading direction
• Whether a reference connector is required
• Whether the sample needs a customized holder
• Whether the fixture could damage or deform the sample before the load is applied

For non-standard samples, customer drawings, photos or sample dimensions should be confirmed before quotation.

Difference from Leakage Testers

This distinction is important because Annex F testing evaluates mechanical connection behavior, while liquid and air leakage testers evaluate sealing performance.

Typical Test Objects

The ISO 80369-20 Annex F Axial Load Tester can be configured for different medical small-bore connector samples depending on the fixture and test method.

Typical test objects include:

• Medical small-bore connector assemblies
• Luer slip connector samples
• Luer lock connector samples
• Syringe and needle connector assemblies
• Infusion connector components
• Catheter connector assemblies
• Connector prototypes for R&D verification
• Connector samples requiring axial load separation testing

For special connector structures, the test fixture should be confirmed before quotation.

Technical Features

• Designed for ISO 80369-20 Annex F related axial load testing
• 0–500N measuring range for medical connector separation evaluation
• 0.01N force resolution and ≤ ±1% force accuracy based on current product configuration
• Controlled axial loading for small-bore connector samples
• Suitable for Luer connector assemblies and related medical connectors
• Fixture configuration can be matched to the connector sample type
• Time setting range up to 0–9999s according to current product data
• Supports connector R&D validation, incoming inspection and production QC
• Documentation or calibration information can be provided where applicable

Operation and Handling Notes

The connector sample should be installed carefully to ensure that the axial load is applied in the correct direction. The fixture should hold the sample securely without damaging the connector interface before the test begins.

Do not use leakage test fixtures as a substitute for axial load fixtures unless the fixture has been confirmed for mechanical loading. The force sensor, sample holder and connector interface should be protected from impact, overload and misalignment.

For formal laboratory testing or regulated quality systems, documentation requirements such as calibration document, fixture configuration and test record format should be confirmed before order placement.