Specification builder · Tier C
Luer (small-bore) connector test system for ISO 80369-20 test methods on ISO 80369-7 connectors
A luer connector test system checks that syringe, IV set, cannula and stopcock luer connectors seal and stay connected, using the ISO 80369-20 test methods (liquid leakage, air leakage under vacuum, stress cracking, pull-off, unscrewing and overriding) against ISO 80369-7 reference connectors. It is bought by drug and medical-device testing laboratories and by local makers of disposables for batch release. It replaces the older ISO 594-1/-2 tests, which are superseded.
What this equipment will do
- Connector types: luer slip and luer lock connectors (ISO 80369-7) on syringes, IV and extension sets, cannulas, needle hubs and stopcocks.
- Other small-bore connector families: neuraxial (ISO 80369-6) and enteral (ISO 80369-3) connectors. (with the optional module)
- Liquid leakage under positive pressure, by falling-drop or pressure-decay method (ISO 80369-20).
- Air leakage under vacuum (subatmospheric pressure) (ISO 80369-20).
- Resistance to separation from axial load (pull-off) (ISO 80369-20).
- Luer lock: resistance to separation from unscrewing (ISO 80369-20).
- Luer lock: resistance to overriding of the threads (ISO 80369-20).
- Luer lock: disconnection by unscrewing, by the revised 2024 method (ISO 80369-20:2024).
- Stress cracking: connector pairs held assembled at the specified torque for the hold period, then leak-tested (ISO 80369-20). (with the optional module)
- Air leakage during aspiration, the test added in ISO 80369-20:2024. (with the optional module)
- Assembly of each specimen to the reference connector with the axial force and torque applied together under instrument control, so results do not depend on the operator. (with the optional module)
- Assembly force and torque curve for each specimen, for comparison with old ease-of-assembly results (information only, not pass/fail). (with the optional module)
Not covered: Connector dimensions (cone taper, length and thread profile) are not measured; they need the profile projector or the optical measuring microscope.; Syringe plunger forces, dead space, dose accuracy and leakage past the plunger need the syringe performance test system (ISO 7886-1).; Needle hub bond strength and cap removal forces need the digital force gauge with test stand (ISO 7864).; Flow rate through IV sets and needles needs the needle and IV set flow rate tester.
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Standards this specification draws on
- ISO 80369-20:2024 Defines the common test methods for small-bore connectors (leakage, subatmospheric air leakage, stress cracking, separation from axial load and unscrewing, overriding, disconnection by unscrewing, air leakage during aspiration) that the system must perform.
- ISO 80369-7:2021 Defines luer slip and luer lock connectors, their performance requirements and test values, and the reference connectors used in every test.
- ISO 80369-1:2018 General requirements for small-bore connectors, including non-interconnectability between connector families.
- IEC 61010-1 Electrical safety standard for laboratory and test equipment.
- IEC 61326-1 EMC requirements for laboratory and measurement equipment.
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; requires calibrated equipment and traceable results.
- ISO 7500-1:2018 Verification and calibration of the force-measuring system of static testing machines.
- 21 CFR Part 11 US FDA rule on electronic records and signatures, applied to test software used for batch release.
- 21 CFR Part 820 US FDA Quality Management System Regulation (aligned with ISO 13485 from 2 Feb 2026) for manufacturers exporting devices to the US.
Common mistakes in tenders for this equipment
- Writing ISO 594-1 / ISO 594-2 in the specification: they are superseded by ISO 80369-7 and ISO 80369-20, whose test values and methods differ, so results to the old standards are not accepted.
- Buying the force/torque tester without a complete, certified set of ISO 80369-7 reference connectors (and a spare set), so no valid test can be run.
- Specifying only a torque tester and forgetting the leakage and subatmospheric air-leakage equipment and the stress-cracking fixtures; ask for a clause-by-clause statement against ISO 80369-20.
- Copying one maker's sensor capacity, software name or integrated pressure unit so only that brand can comply; state the test methods and the force, torque and pressure ranges needed instead.
- Accepting calibration only at full scale: luer tests use very low torques, so calibration and accuracy must be proven at the actual test values with ISO/IEC 17025 certificates.
- Citing the 2015 edition of ISO 80369-20 instead of the 2024 edition, which changed the disconnection-by-unscrewing method, added air leakage during aspiration and widened the humidity range.
- Leaving out yearly calibration, reference-connector resupply and local service, so the instrument loses accreditation after the first year.
- Asking for DRAP medical-device registration of the tester itself: it is laboratory test equipment, so this demand only confuses bidders.