ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector For Testing Female Luer Connectors For Leakage

ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector for testing female Luer Connectors for leakage

Escape Clause:
ISO 80369-7; Page 24; Annex C; Figure C.2; Note 2 states:
The minimum length of the female taper of 10,5 mm is required for testing non-interconnectable characteristics. A minimum length of the female taper of 7,5 mm may be used for the performance tests of Clause 6.
What they are saying here is that if you use an ISO 594/1 Fig 5 Reference Fitting with a certified length of 7.5mm minimum you can use it for all of the tests of ISO 80369-7 Paragraph/Clause 6, but if you sent that Reference fitting out to be certified to match ISO 80369-7 Fig C.2 it will fail because it does not meet the 10.5mm minimum. This escape Clause will allow you to use your old ISO 594/1 Fig 5 Reference Fittings until they wear out or until you cannot convince the oversight party that it is allowed.

From our perspective:
If you request a quote for a new ISO 594/1 Fig 5 Reference Connector from us; we will quote an item which will pass both ISO 594 and ISO 80369-7 requirements. It will be DUO-marked and DUO-certified to both specifications.

ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector
The ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector is used for testing Female Luer Connectors for: Leakage; Separation from axial load; Stress cracking; and Non-interconnectable characteristics in the ISO 80369-7; Clause 6 specified tests. Keeping with the requirements of ISO 80369-7; the Reference Connectors we sell are from hardened stainless steel. The ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector has design details which are not specified in ISO 80369-7 and which allow connection to test equipment. These design details vary by manufacturer so be sure you understand the configuration before you order the Reference Connector. The ISO 80369-7 Fig C2 Male Reference Luer Slip Connector is an integral part of Luer needle and syringe testing.

Uses for the ISO 80369-7; Page 24; Annex C; Fig C.2; Male Reference Luer Slip Connector
Below is a list of tests which are best accomplished by using the ISO 80369-7 Fig C.4 Male Reference Luer Slip Connector:
ISO 80369-7 Clause...
4.1: Non-Interconnectivity
6.1: Fluid Leakage
6.2: Sub-Atmospheric Pressure Air Leakage
6.3: Stress Cracking
6.4: Resistance To Separation From Axial Load

ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector For Testing Female Luer Connectors For Leakage. ISO 80369-7 — Small-bore connectors for liquids and gases in healthcare applications — Part 7: connectors for intravascular or hypodermic applications (the Luer interface). This item is the Figure C.2 gauge of that standard. It is the male luer slip side of the interface. It is used for fluid leakage under positive pressure. Kingpo machines reference connectors and gauges in-house from hardened steel, inspects them against the figure before despatch and supplies them with a calibration certificate.

What it is used for

• Fluid leakage under positive pressure

ISO 80369-7:2016 cancelled and replaced ISO 594-1:1986 and ISO 594-2:1998, consolidating and technically revising their clauses, tables, figures and annexes.

Specification

How the test is run

1. Condition the reference connector and the sample together at the test temperature stated in the standard.
2. Mate the sample to the reference connector with the axial force or torque the standard specifies — never by hand feel alone.
3. Apply the test medium. Leakage tests use liquid under positive pressure or air under sub-atmospheric pressure; mechanical tests use a tensile or compressive load at a controlled rate.
4. Hold for the dwell time in the standard and record the reading.
5. Repeat for the number of samples the protocol calls for and report the worst case, not the average.

Reference connectors are inspection tools. Overriding tests and repeated axial-load tests wear them by design — plan replacement against test cycles.

Choosing the right figure

Annex C (and the equivalent annexes in the other parts) assigns one figure per reference connector, and each figure is certified for a specific set of tests. Picking the wrong one is the most common specification error in this category: the connectors look almost identical, but a figure that is certified for leakage is not the one you use for separation from axial load. Order against the figure number in your test protocol, not against the photograph.

What this is not

A reference connector is not a complete test system. Leakage, sub-atmospheric air leakage and separation-force tests need pressure, vacuum or force applied through ISO 80369-20 test apparatus. It is also not a simple go/no-go dimensional gauge: for a quick fit check on a conical fitting you want a plug gauge or a ring gauge, not a reference connector.

Frequently asked questions

Can I use one reference connector for several tests?

Only the tests the figure is certified for. Different figures are machined to different limits and, in some cases, to different materials, because the test loads differ.

Do you supply the test apparatus as well?

Yes. Kingpo builds the ISO 80369-20 apparatus — leakage, sub-atmospheric air leakage, separation force and unscrewing torque — alongside the reference connectors.

Is a calibration certificate included?

Yes, and we re-calibrate reference connectors you already hold.

Related gauges and equipment

Other gauges and test equipment to the same standard:

• ISO 80369-7 Fig C.2 Luer Gauges
• ISO 80369-7 Fig C.4 Male Luer Reference Connector Hardness Steel Material
• ISO 80369-7 Figure C.2 Male Reference Luer Slip Connector and C.4 Male Luer Reference Connector
• ISO 80369-7 Fig C.3 Luer Gauges
• ISO 80369-7 Fig C.1 Luer Gauges
• ISO 80369-7 Fig C.5 Luer Gauges

Send the standard, figure number and quantity to Kingpo technical sales for a quotation and delivery date.