Specification builder · Tier C
Electromechanical universal testing machine (1-10 kN) for tensile, compression, peel and bond-strength testing of medical devices, gloves, packaging and plastics
A universal testing machine pulls, pushes or peels a sample at a controlled speed while a load cell measures the force, giving tensile strength, joint and bond strength, elongation, seal strength and compression results. Drug and device testing laboratories, local makers of IV sets, catheters, needles and gloves, packaging QC labs and universities use it to test products against ISO and ASTM standards. Its value depends as much on correct low-force load cells, fixtures and accredited calibration as on the frame itself.
What this equipment will do
- Sample types: infusion sets, catheters and hypodermic needles; rubber and nitrile examination gloves; sterile pouches, blister lids and sachets; plastic films, sheets and moulded dumbbells (up to about 1 kN on the smallest frame).
- Sample types: rigid plastic dumbbells and heavier compression tests above 1 kN. (with the optional module)
- Tensile strength of infusion-set tubing joints (ISO 8536-4) and peak tensile force of catheter sections and joints (ISO 10555-1).
- Force-hold test: a set tensile force held for a set time with pass/fail, as ISO 8536-4 joint tests need. (with the optional module)
- Bond strength between needle hub and needle tube (ISO 7864). (with the optional module)
- Examination gloves: tensile strength and ultimate elongation on cut dumbbells (ASTM D3578, ASTM D412). (with the optional module)
- Seal strength of sterile pouches and lids (ASTM F88/F88M). (with the optional module)
- Tensile strength and elongation at break of plastics (ISO 527-1).
- Tensile modulus and exact strain of plastics with an extensometer (ISO 527-1, ISO 9513). (with the optional module)
- Exact elongation of high-stretch materials such as gloves, elastomers and films with a long-travel extensometer. (with the optional module)
- Compression, slow puncture of films and laminates, and three-point bending. (with the optional module)
- Testing at body temperature (37 deg C) where the device standard requires it. (with the optional module)
Not covered: Kink resistance and flow-under-bend of catheters and tubing need the catheter kink resistance and flexibility tester (EN 13868).; Luer connector unscrewing and overriding torque need the digital torque tester for medical connectors (ISO 80369-20).; Burst and leak testing of whole sterile pouches needs a package burst / leak tester, and glove freedom from holes needs the glove water leak test apparatus.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety standard for laboratory and measurement equipment, including the testing machine's controller.
- IEC 61326-1 EMC standard for laboratory electrical equipment; keeps force readings stable near other equipment and on noisy mains.
- ISO 7500-1:2018 Defines how the force-measuring system of a tension/compression machine is verified and what accuracy class (0.5, 1) it reaches.
- ISO 9513:2012 Calibration and classification of extensometers used for elongation and modulus.
- ISO 8536-4:2019 Infusion sets: requires tubing-to-component joints to withstand a set tensile force for a set time.
- ISO 10555-1:2023 Intravascular catheters: includes the peak tensile force test of catheter sections and joints, with preconditioning.
- ISO 7864:2016 Hypodermic needles: includes the requirement and test for the bond between hub and needle tube.
- ASTM D3578-19 Rubber examination gloves: tensile strength and ultimate elongation before and after ageing, tested with ASTM D412 dumbbells.
- ASTM F88/F88M-23 Seal strength test of flexible barrier materials such as sterile pouches and lids.
- ISO 527-1:2019 General principles for tensile testing of plastics (strength, strain, modulus).
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; needs traceable calibration and controlled records.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; applies when electronic test results are used for batch release or regulatory decisions.
Common mistakes in tenders for this equipment
- Copying one maker's brochure figures (an exact capacity, data rate, test space or software name) so only that brand complies; state minimum needs with 'not less than' instead.
- Asking for 'accuracy 0.5%' without saying 'of reading, ISO 7500-1 class 0.5, from x% of capacity'; a figure given as % of full scale is much worse at the low forces device tests use.
- Buying a 5-10 kN frame with one load cell to test IV-set joints and catheters at 10-20 N, where that load cell is outside its verified range; add a 100 N load cell.
- Ordering the machine without product-specific fixtures (needle-hub holder, tubing and joint fixtures, glove dies, peel fixtures), so it stands idle while fixtures are bought separately.
- Accepting the factory calibration certificate instead of an on-site ISO 7500-1 verification by an ISO/IEC 17025 accredited laboratory, which accreditation assessors and courts expect.
- Accepting a 'Part 11 compliant' claim without a live demonstration of audit trail, user levels, e-signatures and protection of raw data.
- Asking for DRAP medical-device registration or ISO 13485 for a testing machine; it is laboratory equipment and these demands only confuse bidders.
- Forgetting the yearly calibration in the after-warranty price, so the lab loses its calibrated status when the warranty ends.