How to Perform ISO 80369 Small-Bore Connectors in Healthcare Applications

Annex B

Principle: The connector under test is assembled to an appropriate reference connector. The medium, as specified in the relevant application part of this series, is introduced into the connection and pressurized to the specified pressure.

Annex C

Principle: A connector is assembled to a reference connector. Water is introduced into the connection and pressurized for the hold period.

Annex D

Principle: Air leakage during aspiration in a connector assembly is tested by measuring the change in subatmospheric pressure over time after the vacuum pressure is applied to the bore of the connector.

Slip connector:

1. Apply an axial force while rotating the slip connector under test in torsion.
2. Make sure the rotation does not exceed 90°.

Locking connector:

1. Apply an axial force while rotating the connector under test in torsion.

• Note: This section covers the mechanical testing portion only

Annex E

Principle: A connector is securely assembled to an appropriate reference connector and the connection is evaluated for stress cracking by demonstrating that it properly seals utilizing the leak test.

Slip connector:

1. Apply an axial force while rotating the slip connector under test in torsion.
2. Make sure the rotation does not exceed 90°.

Locking connector:

1. Apply an axial force while rotating the connector under test in torsion.

• Note: This section covers the mechanical testing portion only

Annex F

Principle: The security of the connection to an axial pull is determined by applying an axial separation force between the assembled connector under test and the appropriate reference connector. The connection is expected to be maintained.

Slip connector:

1. Apply an axial force while rotating the slip connector under test in torsion.
2. Make sure the rotation does not exceed 90°.
3. Apply and hold the axial force in a direction away from the test fixture at the specified rate, at the specified period.
4. Verify that connectors have not completely detached at the interface.

Locking connector:

1. Apply an axial force while rotating the connector under test in torsion.
2. Apply and hold the axial force in a direction away from the test fixture at the specified rate, at the specified period.
3. Verify that connectors have not completely detached at the interface.

Annex G

Principle: The security of connection between male and female locking connectors is determined by inspecting the connection after applying specified unscrewing torque. The connection is expected to be maintained.

Slip connector:

1. Apply an axial force while rotating the slip connector under test in torsion.
2. Make sure the rotation does not exceed 90°.
3. Reverse the torque and apply an unscrewing torque force.
4. Hold the unscrewing torque at the specified period without applying any supplementary force in other directions.

Locking connector:

1. Apply an axial force while rotating the connector under test in torsion.
2. Reverse the torque and apply an unscrewing torque force.
3. Hold the unscrewing torque at the specified period without applying any supplementary force in other directions.

Annex H

Principle: The resistance to overriding of male and female locking connectors is determined by observing the thread or lugs of the connector under test after applying the specified torque.

1. Assemble the connector under test to the appropriate male or female reference connector.
2. Apply the torque as specified in the standard.
3. Hold the torque at this value for the hold period specified without applying any supplementary force in other directions.

Annex I

Principle: The ability to disconnect the connection using a twist of male and female connectors is determined by inspecting the connection after applying the specified torque. The connection is expected to disconnect.

Slip connector:

1. Apply an axial force while rotating the slip connector under test in torsion.
2. Make sure the rotation does not exceed 90°.
3. Let the assembled connectors sit for the specified period.
4. Apply an unscrewing torque to the connector under test at the specified rate until the connection separates without applying any supplementary force in other directions.
5. Record the torque at which the connector under test completely detaches from the reference connector.

Locking connector:

1. Apply an axial force while rotating the connector under test in torsion.
2. Let the assembled connectors sit for the specified period.
3. Apply an unscrewing torque to the connector under test at the specified rate until the connection separates without applying any supplementary force in other directions.
4. Record the torque at which the connector under test completely detaches from the reference connector.