Specification builder · Tier C
Stent securement (dislodgement force) tester for crimped balloon-expandable stents at 37 deg C, with optional trackability / pushability
A stent securement tester measures the force needed to push or pull a crimped stent off its delivery balloon, at body temperature (37 deg C) and usually after the system has been passed through a simulated vessel path. It is bought by drug and device testing labs checking stents for DRAP, by stent and catheter makers for lot release, and by universities. Very few makers sell a purpose-built tester, so most labs use a low-force universal testing machine with a dedicated fixture and heated bath.
What this equipment will do
- Product types: balloon-expandable stents crimped on their balloon delivery catheters (stent delivery systems).
- Crimped stent outer diameters from 0.8 to 2.5 mm covered by one set of fixture inserts or a segmented capture head. (with the optional module)
- Stent securement (dislodgement) force: peak force to move the stent along the balloon, and displacement at peak (ISO 25539-2, ASTM F2394).
- Dislodgement in both the proximal and the distal direction. (with the optional module)
- Specimen conditioning at 37 deg C before the test.
- Test run with stent, balloon and fixture fully immersed in a 37 deg C water / saline bath. (with the optional module)
- Simulated-use pre-conditioning: the stent system is advanced and withdrawn through a curved vessel path over a 0.014 in guidewire before the securement test (FDA 2010 stent guidance). (with the optional module)
- Track force of the delivery system through a tortuous vessel model at 37 deg C (ISO 25539-2). (with the optional module)
- Pushability: proximal push force and push efficiency along the vessel model. (with the optional module)
- Peak tensile force of catheter shafts and bonds (ISO 10555-1 Annex B). (with the optional module)
- Video of the stent-fixture interface synchronised with the force curve. (with the optional module)
Not covered: Radial strength, chronic outward force and crush resistance of stents need the stent radial force tester (ASTM F3067).; Balloon burst pressure, balloon fatigue and compliance (diameter against pressure) need a balloon burst / inflation tester.; Stent durability over hundreds of millions of pulsatile cycles (ASTM F2477) needs a stent/graft pulsatile durability tester.; Crimped stent profile and dimensions need a laser scan micrometer or measuring microscope.
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Standards this specification draws on
- ISO 25539-2:2020 Defines the stent securement (dislodgement) test of balloon-expandable stents on their delivery systems and the related delivery-system tests such as trackability and pushability.
- ASTM F2394-07(2022) Standard guide for measuring securement of a balloon-expandable vascular stent on its delivery system; describes fixtures, conditioning and reporting.
- FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems (2010) Final FDA guidance (April 2010, still current; augmented but not replaced by the August 2015 'Select Updates' guidance) setting regulators' expectations for stent securement testing at body temperature after simulated use; widely used in dossiers for imported stents.
- ISO 10555-1:2023 General requirements for intravascular catheters, including the peak tensile force test that the same frame can run with catheter grips.
- IEC 61010-1 Basic electrical safety of laboratory and test equipment, important for a mains-powered frame used next to a water bath.
- IEC 61326-1:2020 EMC requirements so the low-force measurement is not disturbed by, and does not disturb, other lab equipment.
- ISO 7500-1:2018 Verification and classification of the force-measuring system of the testing machine (accuracy class at low forces).
- ISO/IEC 17025:2017 Competence of testing and calibration labs; drives the need for traceable calibration and validated methods.
- 21 CFR Part 11 Electronic records and signatures; applies where test results are stored electronically for release or regulatory decisions.
- 21 CFR Part 820 FDA Quality Management System Regulation (aligned with ISO 13485 from 2 Feb 2026) governing inspection and test equipment control at device manufacturers that export.
Common mistakes in tenders for this equipment
- Describing a single maker's segmented capture head or proprietary diameter-control feature as mandatory, which makes the tender single-source when a testing machine with an apertured fixture measures the same property.
- Buying the frame without fixture inserts sized for the crimped stents actually tested, so the machine cannot test the first samples received.
- Specifying a 500 N or 1 kN load cell for a test whose results are 0.5-5 N; the frame is accurate but the result is not.
- Leaving out the 37 deg C bath or not checking its temperature, giving falsely high securement values at room temperature.
- Accepting a calibration certificate that is not ISO/IEC 17025 accredited or does not start at the lowest force actually used.
- Choosing basic software for a DTL, so results lack an audit trail and protected raw data when a supplier challenges a failing result.
- Forgetting simulated-use consumables (guidewires, guiding catheters, valves) and the cost of destructive stent samples in the budget.
- No method training or repeatability study, although specimen alignment by the operator is the largest source of variation.