Specification builder · Tier D
Dynamic fatigue testing machine (electrodynamic or servo-hydraulic, 1-10 kN) for medical device components, polymers and small implants
A dynamic fatigue testing machine loads a specimen back and forth millions of times to find how long a part survives under repeated force. Device testing labs, implant and component manufacturers and universities use it to test dental implants, bone plates, polymer parts and tubing to ISO and ASTM methods. Low-force machines (1-10 kN) are usually electrodynamic and oil-free; stent and graft durability testing needs a separate specialised instrument.
What this equipment will do
- Sample types: plastics and metal specimens, films and tubing held in fatigue-rated grips. (with the optional module)
- Sample types: endosseous dental implants (ISO 14801) and bone plates in four-point bending (ASTM F382). (with the optional module)
- Sample types: catheters, tubing, small-bore connectors and hubs, and small moulded device parts. (with the optional module)
- Constant-amplitude fatigue in tension, compression or fully reversed loading, under force or displacement control, counting cycles to failure (up to 10^9 cycles).
- Stiffness tracking during the test and automatic stop on failure (force, displacement or stiffness-change limits).
- Cyclic compression and three- / four-point bending fatigue of plates, rods and flat parts. (with the optional module)
- S-N (load-life) curves across a specimen series, staircase / load-step methods and run-out handling. (with the optional module)
- Block (variable-amplitude) loading and playback of user-defined load profiles from a file. (with the optional module)
- Testing immersed in saline or simulated body fluid at 37 deg C. (with the optional module)
- Testing at -40 to +150 deg C in a temperature chamber. (with the optional module)
- Combined axial and torsional (twisting) fatigue loading. (with the optional module)
- Pulsatile durability of vascular stents and stent grafts on a separate multi-station instrument (ASTM F2477, ISO 25539-2). (with the optional module)
Not covered: The fatigue frame itself cannot run stent/graft pulsatile durability (ASTM F2477); that needs the separate stent/graft durability tester, offered here only as an option.; Stent radial strength, chronic outward force and crush need the stent radial force tester.; Heart valve accelerated wear (ISO 5840) needs a heart valve durability tester.; Wear of hip and knee joint replacements (ISO 14242, ISO 14243) needs a joint wear simulator.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety for laboratory and measurement equipment; the controller, drive electronics and accessories must be safe to operate.
- IEC 61326-1 EMC requirements so the drive and controller neither disturb nor are disturbed by other lab equipment.
- ISO 7500-1:2018 Static force verification and classification (class 0.5 / 1) of the force-measuring system of tension/compression testing machines.
- ASTM E467-21 Verifies that the force shown during constant-amplitude cyclic loading matches the real force on the specimen at test frequency.
- ISO 4965-1:2012 ISO method for dynamic force calibration of uniaxial fatigue testing systems; an accepted alternative to ASTM E467.
- ASTM E4-24 US practice for static force verification of testing machines, often required by device makers exporting to the USA.
- ISO 14801:2016 Dynamic loading (fatigue) test for endosseous dental implants, one of the commonest implant fatigue methods the machine must run.
- ASTM F2477-24 In vitro pulsatile (accelerated radial) durability test of vascular stents; applies only if the stent/graft durability tester is bought.
- ISO 25539-2:2020 Vascular stent standard that requires durability testing; relevant to the optional stent/graft tester.
- 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; relevant when fatigue data support FDA submissions.
Common mistakes in tenders for this equipment
- Copying one maker's exact figures (a specific stroke, maximum frequency, torque or load cell size) so only that brand can comply; state the minimum your test methods need with 'not less than'.
- Asking only for static ISO 7500-1 calibration and forgetting dynamic force verification (ASTM E467 / ISO 4965-1); at test frequency the indicated force can differ from the real force because of fixture mass.
- Buying the load frame without the grips, implant fixtures, saline bath and alignment fixture the methods require, so the machine stands idle waiting for a second purchase.
- Specifying very high frequencies (100 Hz or more) for polymer testing, where specimens heat up and standards limit frequency anyway; ask for what your methods really use.
- Ordering a servo-hydraulic system without budgeting for the hydraulic power unit's three-phase supply, cooling, oil, filters and noise control.
- Bundling a stent/graft durability tester into the same lot as the fatigue frame; it is a separate instrument from very few makers and locks the whole tender.
- Ignoring load-shedding: no online UPS and no power-failure safe stop means multi-week tests are lost and drives are damaged.
- Asking for DRAP medical-device registration or ISO 13485 for the machine: it is test equipment, so this only confuses bidders.