Enersol Testing Equipment and Accessories for ISO 80369-20:2015

Enersol's small bore testing equipment, devices and accessories are designed specifically to meet requirements of ISO 80369-20:2015.

Enersol also has a range of equipment for ISO 594 series, ISO 7886 series, ISO 8537 and other similar standards.

Some of Enersol's ISO 80369-20 equipment is backwards compatible with ISO 594-1:1986 and ISO 594-2:1998, thus allowing a laboratory to continue to test syringes and other medical devices requiring ISO 594 tests. Some of the items in this range also include equipment that can also be used for ISO 7886, ISO 8537 and similar standards.

Enersol also conducts testing of small bore connectors following the methods of ISO 80369-20 in its ISO 17025 accredited laboratory.

To accompany the ISO 80369-20 testing equipment Enersol has a range of reference connectors for ISO 80369-3:2016, IEC 80369-5:2015, ISO 80369-6:2016 and ISO 80369-7:2016. These reference connectors are required for the tests of ISO 80369-20, and the reference connectors can be supplied with the testing equipment.

Click the BUTTONS below to download guidance documents for Enersol Reference Connectors and Equipment.

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To find out more, please contact Enersol by emailing or submitting a request for catalogue.

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Testing equipment for ISO 80369-20:2015

Enersol's ISO 80369-20 testing equipment and devices come with the necessary power supplies, weights and accessories for testing. Typically the requirements to use this equipment are the appropriate reference connectors (can be supplied with the equipment), a sturdy level benchtop and some items require mains power, and/or compressed air.

(Cat. # S15A) Connector Assembly Device

Required for ISO 80369-20:2015, Annex B to I

This is used for the assembly of the reference connector and test sample in accordance with the ISO 80369-20:2015 and the parts (eg. ISO 80369-3, ISO 80369-6, ISO 80369-7).

This device is also used for ISO 80369-20:2015 Annex E - Stress Cracking and ISO 80369-20:2015 Annex H - Resistance to overriding

The device has a fixed known side weight and fixed known axial weight. Supplied with the device is an additional side weight which is used for the resistance to overriding test.

The weights oppose forces and torques applied by the user. When the weights are rising, it indicates that the correct force and torque are being applied.

(Cat. # S77) Automated Pressure Decay Tester

ISO 80369-20:2015 Annex B - Leakage by Pressure Decay

This tester has a built-in touch screen. The user loads the assembled test sample, performs the test and the tester provides a result on-screen.

The user must first assemble the test sample to the appropriate reference connector using S15A. The tester applies a known pressure and measures the pressure drop over the test period.

The volume of the testing apparatus is known, and the volume of the test sample is available from the manufacturer of the test sample. The tester calculates a measure of leakage rate as defined in ISO 80369 and compares it with limits in the standard.

(Cat. # S16A) Positive Pressure Liquid Leakage Tester

ISO 80369-20:2015 Annex C - Positive Pressure Liquid Leakage

This tester is backwards compatible and can be used for the liquid leakage test of the ISO 594 series, liquid leakage past piston of ISO 7886 series and ISO 8537, as well as liquid leakage past nozzle and needle hub assembly.

The user must first assemble the test sample with a reference connector using S15A. Water is introduced into the connection and pressurized by the tester for a hold period.

(Cat. # S78) Automated Sub-atmospheric Pressure Air Leakage Tester

ISO 80369-20:2015 Annex D - Subatmospheric-pressure Air Leakage

This tester has a built-in touch screen. The user loads the assembled test sample, performs the test and the tester provides a result on-screen.

The user must first assemble the test sample with a reference connector using S15A. The assembly under test is attached to a vacuum chamber of known volume. The rise in absolute pressure is recorded over the test period and a measure of the leakage rate is calculated in accordance with the standard. This is compared with the stipulated limit.

(Cat. # S18A) Separation Force Tester

ISO 80369-20:2015 Annex F - Resistance to Separation from Axial Load

The user must first assemble the test sample to the appropriate reference connector using S15A. The separation force device is set up by raising the test platform to the start position and placing the known axial weight on the platform.

The required separation force in the appropriate standard is applied using a known, fixed weight. The weight is applied over a period of a few seconds, by gradually withdrawing support for it.

(Cat. # S19A) Unscrewing Torque Device

ISO 80369-20:2015 Annex G - Resistance to Separation from Unscrewing

The user must first assemble the test sample to the appropriate reference connector using S15A. A known weight is hung from a pully of known radius, which thus applies a known unscrewing torque to the assembled sample under test.

(Cat. # S79) Disconnection by Unscrewing Tester

ISO 80369-20:2015 Annex I - Disconnection by Unscrewing

The user must first assemble the test sample to the appropriate reference connector using S15A. As the test sample is turned by the operator, a known weight swings out from its rest position, and increases the unscrewing torque. The tester calculates and displays the torque, based on the weight, the angle and the dimensions of the device.

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For Laboratory equipment and testing enquiries please contact
Lisa Henretty or Hung Truong