Specification builder · Tier A
Digital push-pull force gauge with manual or motorised test stand, interchangeable load cells and device test fixtures
A digital force gauge mounted on a test stand pulls or pushes on a sample and records the peak force, for example the force to pull a needle out of its hub, separate a luer connector, push on a connector or remove a cap. Drug and device testing laboratories, local syringe, needle and IV-set makers and universities use it to check products against ISO device standards. A motorised stand, the right load cell ranges and proper fixtures matter more than the gauge itself.
What this equipment will do
- Products handled: small device parts such as needles, cannulas, luer connectors, IV set joints, caps and tubing, held on the stand; peak pull (tension) and push (compression) force recorded with pass/fail limits, on a force system verified and classed to ISO 7500-1.
- Needles, IV cannulas and pen needles: bond strength between hub and needle tube (ISO 7864; pen needles ISO 11608-2). (with the optional module)
- Luer connectors: resistance to separation from axial load (pull-off) against ISO 80369-7 reference connectors (ISO 80369-20). (with the optional module)
- Infusion (IV) sets: tensile strength of joints and connections at the specified force (ISO 8536-4). (with the optional module)
- Catheters: peak tensile force of catheter sections and hub joints, within the stand and load-cell capacity (ISO 10555-1). (with the optional module)
- Caps and protectors: removal force of syringe, pen-needle and IV set caps (ISO 11608-2 for pen needles), and connection (insertion) force. (with the optional module)
- IV set spike: insertion and withdrawal force into a test closure. (with the optional module)
- Peel strength of tapes, labels and pouch seals at 90 or 180 degrees. (with the optional module)
- Tests at a set pulling speed or hold time, with stop at a set force or at break, so results do not depend on the operator. (with the optional module)
- Force-displacement curves and force at a given distance. (with the optional module)
- Both low forces (a few N, e.g. luer and cap tests) and high forces (hundreds of N, e.g. needle hub and tubing joints) measured accurately on separate load cell ranges. (with the optional module)
- Torque on caps and threaded connectors, read on the same indicator. (with the optional module)
Not covered: Needle point sharpness and penetration force need the needle penetration force tester.; Full ISO 80369-20 luer testing (leakage, stress cracking, unscrewing, overriding) needs the luer connector test system; unscrewing and opening torques of connectors and caps on their own need the digital torque tester.; Forces above the stand capacity and full material tensile tests (tensile strength and elongation of tubing, films and catheter materials) need the universal testing machine.; Leak and burst tests on syringes, IV sets and catheters need the device pressure and vacuum leak tester.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety standard for laboratory and test equipment; applies to the mains-powered stand, controller and chargers.
- IEC 61326-1 EMC standard for laboratory equipment, so the motor drive does not disturb readings or other instruments.
- ISO 7500-1:2018 Verification and classification (class 0.5, 1, 2) of the force measuring system of tension/compression testing machines; defines how accurate the system really is.
- ISO 376 Calibration of the force-proving instruments used to verify the system under ISO 7500-1; ensures the calibration itself is traceable.
- ISO 7864:2016 Sterile hypodermic needles; sets the hub-to-needle-tube bond strength test that the system must perform.
- ISO 80369-20:2024 Common test methods for small-bore (luer) connectors, including resistance to separation from axial load, which needs controlled force and reference connectors.
- ISO 8536-4 Infusion sets for single use; requires tensile tests of joints and connections at specified forces.
- ISO 11608-2 Pen needles; includes bond strength and cap / needle removal forces measured with a force tester.
- ISO 10555-1 Intravascular catheters general requirements; includes peak tensile force of catheter sections and hub joints (high forces may need a universal testing machine).
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; requires calibrated, traceable equipment with known measurement uncertainty.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; relevant where electronic force-test results are used for batch release or regulatory decisions.
Common mistakes in tenders for this equipment
- Copying one brand's numbers (an exact sampling rate, a stroke length or a speed range such as 0.5 to 1,100 mm/min) so only that brand complies; state the minimum the test standards really need.
- Asking only for "accuracy 0.1%" without saying "of full scale" and without an ISO 7500-1 class and range, so a gauge that is inaccurate at low forces can still comply on paper.
- Buying one large load cell (for example 500 N) and then testing 2-10 N luer and cap forces at the bottom of its range, where the error can be several percent.
- Leaving out the fixtures (needle hub holders, ISO 80369-7 reference connectors, cap and spike fixtures), so the instrument sits unused while jigs are made locally without control.
- Accepting a factory "calibration certificate" instead of an ISO 7500-1 verification by an ISO/IEC 17025 accredited laboratory, which accreditation assessors will not accept.
- Specifying a manual stand for tests that state a rate or hold time, so results depend on the operator and cannot be defended in an appeal.
- Asking for DRAP medical-device registration or ISO 13485 from the supplier: this is test equipment, and the demand only excludes valid bidders.
- Not fixing the yearly calibration price in the tender, so the lab later pays high single-source calibration charges.