Specification builder · Tier B
Digital torque tester for luer lock and other small-bore medical connectors and closures (ISO 80369-7 / ISO 80369-20), low range about 0.01-2 N.m
A digital torque tester turns a connector against a standard reference connector and measures the small torque needed to tighten, unscrew or override it. Drug and device testing laboratories, local syringe and IV-set makers and universities use it to check luer lock connectors against ISO 80369-7 and ISO 80369-20, and some labs also use it for bottle and vial cap torque. It is laboratory test equipment, not a medical device.
What this equipment will do
- Product types: luer lock and luer slip connectors of syringes, IV and extension sets, three-way stopcocks, IV cannula and catheter hubs and needle hubs (ISO 80369-7), in the low torque range of about 0.02 to 0.3 N.m.
- Product types: larger connectors, needle-free valves and caps of prefilled syringes and vials, up to 2 N.m. (with the optional module)
- Product types: application and removal torque of bottle and vial screw caps, 5 N.m or more (ASTM D2063). (with the optional module)
- Product types: other small-bore connectors (for example enteral and neuraxial, ISO 80369 series) and luer lock adaptors and tip caps of prefillable syringes (ISO 11040-4). (with the optional module)
- Unscrewing torque: resistance to separation from unscrewing and disconnection by unscrewing, clockwise and anticlockwise, with peak torque recorded (ISO 80369-20).
- Resistance to overriding: torque raised to a set value and held, to check that the threads do not jump (ISO 80369-20), with torque-angle curves. (with the optional module)
- Assembly of the connector under a set push force and torque at the same time, as ISO 80369-20 requires. (with the optional module)
- Stress cracking: connectors kept assembled at the set torque and force for the test period (ISO 80369-20). (with the optional module)
- Resistance to separation from axial load (pull-off test, ISO 80369-20). (with the optional module)
- Leakage of the connection under positive pressure and vacuum (ISO 80369-20). (with the optional module)
- Repeated connect and disconnect cycling (not less than 100 cycles) with torque and angle recorded for each cycle. (with the optional module)
Not covered: Dimensional checks of the luer cone and thread (taper, length, diameters) need ISO 80369-7 gauges or a measuring microscope / profile projector.; Syringe plunger forces, dead space and syringe leakage need the syringe performance test system (ISO 7886-1).; Needle-hub bond strength, tubing joint strength and other pull tests above 100 N need a universal testing machine (ISO 7864, ISO 8536-4).
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Standards this specification draws on
- IEC 61010-1 Electrical safety of laboratory and test equipment; the basic safety standard for the tester.
- IEC 61326-1 EMC requirements for laboratory and measurement equipment, so the sensitive low-range torque signal is not disturbed and the tester does not disturb others.
- ISO 80369-20:2024 Test-method standard for small-bore connectors: defines the assembly, unscrewing, overriding, stress-cracking and separation tests the tester must perform.
- ISO 80369-7:2021 Luer connectors for intravascular and hypodermic use: sets the reference connectors and the torque and axial force values used in the tests.
- ISO 11040-4:2024 Prefillable glass syringes: includes torque tests on luer lock adaptors and tip caps for labs testing prefilled syringes.
- ASTM D2063/D2063M-24 Test methods for torque retention of continuous-thread closures using non-automated (manual) torque testing equipment, used when the tester is also used for bottle and vial caps.
- BS 7882:2017 Method for calibration and classification of torque measuring devices, used to calibrate and classify the torque sensors.
- DIN 51309:2022 German standard for calibration of static torque measuring devices; an accepted alternative basis for the torque calibration.
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; requires calibrated, traceable equipment and controlled records.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; the reference for audit trail and e-signature functions in the test software.
- EU GMP Annex 11 EU / PIC/S GMP rule for computerised systems, applied by DRAP-aligned GMP inspections to QC software.
Common mistakes in tenders for this equipment
- Specifying one large torque range (for example 0-10 N.m) for luer tests: the error at 0.02-0.15 N.m is then larger than the value being measured. State the maximum error over 0.02-0.3 N.m instead.
- Leaving out ISO 80369-7 stainless reference connectors and product holders, so the tester arrives but cannot run a standard test.
- Citing withdrawn ISO 594-1 / ISO 594-2 or the 2015 edition of ISO 80369-20 instead of ISO 80369-7:2021 and ISO 80369-20:2024.
- Copying one maker's exact speed range, sensor capacities or axial-load method so only that brand can comply; write minimum performance with 'not less than / not more than'.
- Accepting a calibration certificate that does not cover the lowest test torque or the anticlockwise (unscrewing) direction, or that is not from an ISO/IEC 17025 accredited torque laboratory.
- Buying a bottle-cap torque tester (5-20 N.m) and expecting it to measure luer unscrewing torque correctly.
- Demanding DRAP medical-device registration or ISO 13485 for a laboratory test instrument, which only confuses bidders and reduces competition.
- Forgetting the 48-hour stress-cracking fixtures and the temperature/humidity logging that ISO 80369-20 requires.