ISO80369-20 Annex D Subatmospheric Air Leakage Tester

The ISO 80369-20 Annex D Subatmospheric Air Leakage Tester is designed for medical small-bore connector air leakage evaluation under controlled negative-pressure conditions. Unlike liquid leakage testing, Annex D focuses on air leakage behavior when the connector assembly is exposed to a subatmospheric pressure condition.

This tester is suitable for medical device manufacturers, R&D laboratories, quality control departments and third-party testing laboratories that need to verify connector sealing performance according to ISO 80369-20 Annex D related test requirements. Depending on the sample type, the tester may be used together with suitable connector fixtures, adapters or ISO 80369-7 reference connectors.

For customers working with Luer slip, Luer lock or other small-bore connector assemblies, KINGPO can help review the connector type and test method before quotation to confirm the proper fixture and test configuration.

What Annex D Subatmospheric Air Leakage Testing Verifies

ISO 80369-20 Annex D air leakage testing is used to evaluate whether a medical small-bore connector assembly can maintain sealing performance under subatmospheric pressure. The test is especially relevant when the connector design, mating condition or assembly quality may affect air tightness.

Typical verification purposes include:

• Checking air leakage behavior of medical small-bore connector assemblies
• Evaluating Luer connector sealing performance under negative-pressure conditions
• Supporting R&D verification for connector design changes
• Supporting incoming inspection or production QC for connector components
• Preparing samples for ISO 80369 related type testing or internal validation

This tester is not a liquid leakage tester and should not be used to replace ISO 80369-20 Annex B / Annex C liquid leakage testing equipment.

Testing Principle

During the test, the connector sample is installed on a suitable fixture or reference connector configuration. The tester applies a controlled subatmospheric pressure condition to the connector assembly. The system then monitors the leakage-related response, such as pressure change or air leakage result, according to the selected test method and equipment configuration.

The actual test setup depends on the connector type, sample geometry and required ISO 80369-20 Annex D test procedure. For Luer connector samples, appropriate ISO 80369-7 reference connectors may be required to create the correct mating interface.

The tester helps laboratories perform repeatable air leakage evaluation while keeping the sample connection, pressure condition and result recording under controlled test conditions.

Difference from ISO 80369-20 Liquid Leakage Tester

This difference should be clearly shown on the page so customers do not confuse Annex D air leakage testing with Annex B / Annex C liquid leakage testing.

Typical Test Objects

The ISO 80369-20 Annex D Air Leakage Tester can be configured for different medical small-bore connector samples, depending on the test method and fixture requirement.

Typical test objects include:

• Luer connector assemblies
• Male and female Luer slip connector samples
• Male and female Luer lock connector samples
• Syringe and needle connector assemblies
• Infusion connector components
• Catheter connector assemblies
• Medical small-bore connector prototypes
• Connector samples requiring ISO 80369 related air leakage verification

For non-standard samples or special connector geometry, the fixture configuration should be confirmed before quotation.

Technical Features

• Designed for ISO 80369-20 Annex D related subatmospheric air leakage testing
• Provides controlled negative-pressure / subatmospheric test conditions
• Suitable for medical small-bore connectors and Luer connector assemblies
• Fixture configuration can be matched to the customer’s sample type
• Can be used with appropriate ISO 80369-7 reference connectors where required
• Supports repeatable connector air leakage evaluation in R&D and QC laboratories
• Test process and result recording can be configured according to project requirements
• Documentation or calibration information can be provided where applicable
• Suitable for manufacturers, testing laboratories and medical device quality teams

Technical Configuration Notes

Because connector samples and laboratory test methods may differ, the final tester configuration should be confirmed according to the required ISO 80369-20 Annex D test scope.

Do not list unconfirmed pressure range, leakage range, resolution or accuracy values on the page unless they are supported by the actual product specification or calibration document.

Operation and Handling Notes

Before testing, the user should confirm the sample type, connector gender, mating interface and applicable test procedure. The fixture and connector interface should be clean and properly installed to avoid false leakage results caused by poor sample mounting.

During operation, the tester should be used according to the selected Annex D test method and internal laboratory procedure. The sample should not be forced into an incompatible fixture or reference connector. After testing, the fixture and connector interface should be cleaned and stored properly to maintain repeatable test conditions.

For regulated laboratories or formal verification projects, documentation requirements should be confirmed before order placement, including calibration document, configuration list, fixture drawing or test record format where applicable.

Relationship with ISO 80369-7 Reference Connectors

ISO 80369-20 provides common test methods for small-bore connector performance evaluation, while ISO 80369-7 is commonly associated with intravascular and hypodermic Luer connector applications. For Luer connector testing, the correct reference connector or gauge may be required depending on the connector type and test method.

For example:

• Female Luer connector samples may require suitable male reference connectors.
• Male Luer connector samples may require suitable female reference connectors.
• Dimensional pre-checking may require the ISO 80369-7 Male Plug Gauge or Female Ring Gauge.
• A complete ISO 80369-7 Luer Gauge Set may be useful for laboratories handling multiple connector types.

KINGPO can help confirm whether the Annex D Air Leakage Tester should be supplied with specific ISO 80369-7 reference connectors, dimensional gauges or customized fixtures.