ISO 80369-7 Luer Gauges

ISO 80369-7 Fig C.1 Luer Gauges

ISO80369-7 Luer Gauges

  • Model:

C.1 is the female reference Luer lock connector used to evaluate male Luer lock fittings. It is the connector you reach for when the question is whether a male locking connector seals, assembles smoothly, releases at the specified torque, or survives stress cracking over time.

What this gauge tests

  • Fluid leakage
  • Ease of assembly
  • Unscrewing torque
  • Stress cracking
  • Non-interconnectable characteristics

How it differs from the neighbouring figure

C.1 and C.3 are both female reference connectors built for male Luer lock fittings, which is why they are so often confused. The split is by test purpose: C.1 covers leakage, assembly, unscrewing torque and stress cracking; C.3 covers separation force from axial load and resistance to overriding (thread stripping). A laboratory qualifying a male Luer lock connector to the full Clause 6 set generally needs both.

Before you buy

Because C.1 is the connector that seals against the male taper, its own taper surface is the measurement-critical face. It is supplied with the dimensional inspection record matching the Figure C.1 drawing, and the taper length note below applies to it.

What are these not

These are reference connectors, not complete test systems. Leakage, sub-atmospheric air leakage and axial load separation require pressure, vacuum or force applied through ISO 80369-20 test equipment. They are also not dimensional gauges: for a simple fit check on a Luer interface you want a male plug gauge or a female ring gauge, not an Annex C reference connector.

Related reference connectors

The other figures in the same ISO 80369-7 Annex C family:

Not sure which figure your test protocol calls for? The ISO 80369-7 Luer gauge overview sets out all six figures side by side and explains the three pairs that get confused.

ISO 80369-7 Fig C.1 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). This item is the Figure C.1 gauge of that standard. 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

StandardISO 80369-7
Figure / annexFigure C.1
MaterialHardened stainless / tool steel
CalibrationCalibration certificate supplied
Made byKingpo — machined, inspected and calibrated in-house

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:

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

FigureReference connectorTest objectTests covered
C.1Female, Luer lockMale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.2Male, Luer slipFemale Luer slipLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.3Female, Luer lockMale Luer lockSeparation from axial load, resistance to overriding
C.4Male, Luer lockFemale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.5Female, Luer slipMale Luer slipLeakage, separation from axial load, stress cracking, non-interconnectable characteristics
C.6Male, Luer lockFemale Luer lockSeparation 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.

Standard figureISO 80369-7 Annex C, Figure C.1
Reference connector typeFemale reference conical fitting
Luer configurationLuer lock
Test objectmale Luer lock fittings
Tests coveredFluid leakage, Ease of assembly, Unscrewing torque, Stress cracking, Non-interconnectable characteristics
Cone taper0.06 : 1
MaterialHardened stainless steel
HardnessHRC 58-62
Surface roughness, critical surfacesRa ≤ 0.8 µm
Edge radius, lugs and threads0.15 mm - 0.20 mm
Radius or chamfer R≤ 0.5 mm
Taper length≥ 10.5 mm required for non-interconnectable characteristic tests; 7.5 mm minimum permitted for Clause 6 performance tests
UnitsMillimetres unless otherwise stated

Dimensional tolerances follow the ISO 80369-7 Annex C drawing for this figure. Confirm the drawing revision, certification scope and documentation package required by your quality system before ordering.

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

FigureReference connectorTest objectTests covered
C.1Female, Luer lockMale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.2Male, Luer slipFemale Luer slipLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.3Female, Luer lockMale Luer lockSeparation from axial load, resistance to overriding
C.4Male, Luer lockFemale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.5Female, Luer slipMale Luer slipLeakage, separation from axial load, stress cracking, non-interconnectable characteristics
C.6Male, Luer lockFemale Luer lockSeparation 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.

ISO80369 Testing Equipment,Luer Gauge,ISO80369 Gauge,ISO5356 Gauge


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

FigureReference connectorTest objectTests covered
C.1Female, Luer lockMale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.2Male, Luer slipFemale Luer slipLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.3Female, Luer lockMale Luer lockSeparation from axial load, resistance to overriding
C.4Male, Luer lockFemale Luer lockLeakage, ease of assembly, unscrewing torque, stress cracking, non-interconnectable characteristics
C.5Female, Luer slipMale Luer slipLeakage, separation from axial load, stress cracking, non-interconnectable characteristics
C.6Male, Luer lockFemale Luer lockSeparation 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.