ISO 80369-7 Luer Gauges. ISO 80369-7 — Small-bore connectors for liquids and gases in healthcare applications — Part 7: connectors for intravascular or hypodermic applications (the Luer interface). It is the reference luer side of the interface. 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
- Dimensional and mechanical checks on the connector under test
- Repeatable mating with the sample so results are comparable between laboratories
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
| Standard | ISO 80369-7 |
| Material | Hardened stainless / tool steel |
| Calibration | Calibration certificate supplied |
| Made by | Kingpo — machined, inspected and calibrated in-house |
How the test is run
- Condition the reference connector and the sample together at the test temperature stated in the standard.
- Mate the sample to the reference connector with the axial force or torque the standard specifies — never by hand feel alone.
- 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.
- Hold for the dwell time in the standard and record the reading.
- 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.2 Male Reference Luer Slip Connector For Testing Female Luer Connectors For Leakage
- ISO 80369-7 Fig C.1 Luer Gauges
Send the standard, figure number and quantity to Kingpo technical sales for a quotation and delivery date.
ISO 80369-7 Annex C defines six reference connectors for Luer lock and Luer slip testing, numbered C.1 to C.6. They are the controlled counterparts your sample connector is mated against, and picking the wrong one is the most common specification error in Luer testing - not because the parts look different, but because several of them look almost identical and are certified for different test clauses.
The table below is the short version. Three of the six are female reference connectors used to test male samples (C.1, C.3, C.5); three are male reference connectors used to test female samples (C.2, C.4, C.6). Within each group the figures are split by test purpose, not by size.
Which figure do you need
| Figure | Reference connector | Test object | Tests covered |
|---|---|---|---|
| C.1 | Female, Luer lock | Male Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.2 | Male, Luer slip | Female Luer slip | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.3 | Female, Luer lock | Male Luer lock | Separation from axial load, resistance to overriding |
| C.4 | Male, Luer lock | Female Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.5 | Female, Luer slip | Male Luer slip | Leakage, separation from axial load, stress cracking, non-interconnectable characteristics |
| C.6 | Male, Luer lock | Female Luer lock | Separation from axial load, resistance to overriding |
The three pairs that get confused
C.1 versus C.3. Both are female reference connectors for male Luer lock fittings. C.1 carries the sealing and torque test set; C.3 carries separation force and overriding resistance. A full Clause 6 qualification of a male Luer lock connector needs both.
C.4 versus C.6. Both are male reference connectors for female Luer lock fittings, with the same split: C.4 for sealing and torque, C.6 for pull-and-strip.
C.2 versus C.5. Both involve Luer slip, but they point in opposite directions. C.2 is the male reference connector that tests female slip fittings; C.5 is the female reference connector that tests male slip fittings.
The 10.5 mm and 7.5 mm taper length rule
A minimum taper length of 10.5 mm is required for the non-interconnectable characteristic tests. A minimum of 7.5 mm may be used for the Clause 6 performance tests. This matters in practice: an older ISO 594 reference fitting certified to a 7.5 mm minimum will pass the Clause 6 performance work but will not satisfy a reviewer asking for the non-interconnectable characteristic test. If your notified body or lab asks for that test, the reference connector has to meet the longer dimension.
Common specification and materials
All six connectors are machined from hardened stainless steel at HRC 58-62, with a 0.06:1 cone taper, surface roughness Ra of 0.8 µm or better on critical surfaces, and an edge radius of 0.15 mm to 0.20 mm on lugs and threads. Any radius or chamfer marked R on the drawing is 0.5 mm or less.
What these are not
These are reference connectors, not test apparatus. Pressure, vacuum and axial load come from ISO 80369-20 test equipment, which is a separate purchase. They are also not dimensional gauges: for a simple fit or geometry check on a Luer interface you want a male plug gauge or a female ring gauge. The reference connector exists to be the controlled mating part in a defined test configuration.
The dimensional limits behind all six gauges — Ød, ØD, the Luer lock thread major diameter, the taper length and the 6 % taper angle — are tabulated in millimetres on the Luer dimensions quick reference.
Not sure which figure your protocol calls for? Send us the clause numbers and we will tell you which connectors to order, or quote the six-piece set.
Parameters of the ISO 80369-7 Luer Gauges. Dimensions and limits are those of the reference connector defined by the standard named above.
| Standard | ISO 80369-7 |
| Reference connector | Reference luer |
| Material | Hardened stainless / tool steel |
| Scope of supply | Reference connector / gauge and calibration certificate |
| Calibration | Calibration certificate supplied; re-calibration available |
| Origin | Kingpo — machined, inspected and calibrated in-house |
Custom versions, alternative materials and re-calibration are available. Send the standard, figure number and quantity for a quotation. Reference connectors are consumable inspection tools — plan replacement against test cycles.
ISO 80369-7 Annex C defines six reference connectors for Luer lock and Luer slip testing, numbered C.1 to C.6. They are the controlled counterparts your sample connector is mated against, and picking the wrong one is the most common specification error in Luer testing - not because the parts look different, but because several of them look almost identical and are certified for different test clauses.
The table below is the short version. Three of the six are female reference connectors used to test male samples (C.1, C.3, C.5); three are male reference connectors used to test female samples (C.2, C.4, C.6). Within each group the figures are split by test purpose, not by size.
Which figure do you need
| Figure | Reference connector | Test object | Tests covered |
|---|---|---|---|
| C.1 | Female, Luer lock | Male Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.2 | Male, Luer slip | Female Luer slip | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.3 | Female, Luer lock | Male Luer lock | Separation from axial load, resistance to overriding |
| C.4 | Male, Luer lock | Female Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.5 | Female, Luer slip | Male Luer slip | Leakage, separation from axial load, stress cracking, non-interconnectable characteristics |
| C.6 | Male, Luer lock | Female Luer lock | Separation from axial load, resistance to overriding |
The three pairs that get confused
C.1 versus C.3. Both are female reference connectors for male Luer lock fittings. C.1 carries the sealing and torque test set; C.3 carries separation force and overriding resistance. A full Clause 6 qualification of a male Luer lock connector needs both.
C.4 versus C.6. Both are male reference connectors for female Luer lock fittings, with the same split: C.4 for sealing and torque, C.6 for pull-and-strip.
C.2 versus C.5. Both involve Luer slip, but they point in opposite directions. C.2 is the male reference connector that tests female slip fittings; C.5 is the female reference connector that tests male slip fittings.
The 10.5 mm and 7.5 mm taper length rule
A minimum taper length of 10.5 mm is required for the non-interconnectable characteristic tests. A minimum of 7.5 mm may be used for the Clause 6 performance tests. This matters in practice: an older ISO 594 reference fitting certified to a 7.5 mm minimum will pass the Clause 6 performance work but will not satisfy a reviewer asking for the non-interconnectable characteristic test. If your notified body or lab asks for that test, the reference connector has to meet the longer dimension.
Common specification and materials
All six connectors are machined from hardened stainless steel at HRC 58-62, with a 0.06:1 cone taper, surface roughness Ra of 0.8 µm or better on critical surfaces, and an edge radius of 0.15 mm to 0.20 mm on lugs and threads. Any radius or chamfer marked R on the drawing is 0.5 mm or less.
What these are not
These are reference connectors, not test apparatus. Pressure, vacuum and axial load come from ISO 80369-20 test equipment, which is a separate purchase. They are also not dimensional gauges: for a simple fit or geometry check on a Luer interface you want a male plug gauge or a female ring gauge. The reference connector exists to be the controlled mating part in a defined test configuration.
The dimensional limits behind all six gauges — Ød, ØD, the Luer lock thread major diameter, the taper length and the 6 % taper angle — are tabulated in millimetres on the Luer dimensions quick reference.
Not sure which figure your protocol calls for? Send us the clause numbers and we will tell you which connectors to order, or quote the six-piece set.
ISO 80369-7 Annex C defines six reference connectors for Luer lock and Luer slip testing, numbered C.1 to C.6. They are the controlled counterparts your sample connector is mated against, and picking the wrong one is the most common specification error in Luer testing - not because the parts look different, but because several of them look almost identical and are certified for different test clauses.
The table below is the short version. Three of the six are female reference connectors used to test male samples (C.1, C.3, C.5); three are male reference connectors used to test female samples (C.2, C.4, C.6). Within each group the figures are split by test purpose, not by size.
Which figure do you need
| Figure | Reference connector | Test object | Tests covered |
|---|---|---|---|
| C.1 | Female, Luer lock | Male Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.2 | Male, Luer slip | Female Luer slip | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.3 | Female, Luer lock | Male Luer lock | Separation from axial load, resistance to overriding |
| C.4 | Male, Luer lock | Female Luer lock | Leakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics |
| C.5 | Female, Luer slip | Male Luer slip | Leakage, separation from axial load, stress cracking, non-interconnectable characteristics |
| C.6 | Male, Luer lock | Female Luer lock | Separation from axial load, resistance to overriding |
The three pairs that get confused
C.1 versus C.3. Both are female reference connectors for male Luer lock fittings. C.1 carries the sealing and torque test set; C.3 carries separation force and overriding resistance. A full Clause 6 qualification of a male Luer lock connector needs both.
C.4 versus C.6. Both are male reference connectors for female Luer lock fittings, with the same split: C.4 for sealing and torque, C.6 for pull-and-strip.
C.2 versus C.5. Both involve Luer slip, but they point in opposite directions. C.2 is the male reference connector that tests female slip fittings; C.5 is the female reference connector that tests male slip fittings.
The 10.5 mm and 7.5 mm taper length rule
A minimum taper length of 10.5 mm is required for the non-interconnectable characteristic tests. A minimum of 7.5 mm may be used for the Clause 6 performance tests. This matters in practice: an older ISO 594 reference fitting certified to a 7.5 mm minimum will pass the Clause 6 performance work but will not satisfy a reviewer asking for the non-interconnectable characteristic test. If your notified body or lab asks for that test, the reference connector has to meet the longer dimension.
Common specification and materials
All six connectors are machined from hardened stainless steel at HRC 58-62, with a 0.06:1 cone taper, surface roughness Ra of 0.8 µm or better on critical surfaces, and an edge radius of 0.15 mm to 0.20 mm on lugs and threads. Any radius or chamfer marked R on the drawing is 0.5 mm or less.
What these are not
These are reference connectors, not test apparatus. Pressure, vacuum and axial load come from ISO 80369-20 test equipment, which is a separate purchase. They are also not dimensional gauges: for a simple fit or geometry check on a Luer interface you want a male plug gauge or a female ring gauge. The reference connector exists to be the controlled mating part in a defined test configuration.
The dimensional limits behind all six gauges — Ød, ØD, the Luer lock thread major diameter, the taper length and the 6 % taper angle — are tabulated in millimetres on the Luer dimensions quick reference.
Not sure which figure your protocol calls for? Send us the clause numbers and we will tell you which connectors to order, or quote the six-piece set.