Information on the most widely used ASTM standards within the materials testing industry
ISO 25539‑3:2024 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
ISO 25539-3 defines mechanical performance tests as core bench evaluations for filter systems (filter + delivery/retrieval/conversion systems), plus supplementary tests for materials, imaging, biocompatibility, clinical validation, sterilization and packaging. Include the Filter Tensile Strength, Torsional Bond Strength,Tensile Bond Strength, Radial Force, Force to Deploy, test etc., Below is the details mechanical testing introduction, UnitedTest offer most of the testing equipment required, contact with our engineer today for more details at export@unitedtest.com.

Detailed Mechanical Tests of ISO 25539-3
Mechanical tests verify delivery/deployment/retrieval operability and long-term structural stability of vena cava filters, preventing migration, fracture, perforation or retrieval failure.
| Test | Item | Details |
| Tensile Bond Strength | Purpose | Measure tensile strength of joints/connections in delivery/retrieval/conversion systems. |
| Test Method | Tension test on bonded joints until failure; record peak failure force. | |
| Test Equipment | Universal mechanical tester, gripping fixtures, 37 °C incubator. | |
| Test Sample | System components (distal tip, hub bonds) after simulated use. | |
| Test Procedure | Condition samples (tracking/deployment cycles). Grip sample ends; apply tension at 200 mm/min. Record failure force and failure mode/location. | |
| Importance | Prevent component separation during clinical use. | |
| Application | All delivery/retrieval/conversion system joints. | |
| Torsional Bond Strength | Purpose | Evaluate torsional strength of bonds under clinical twisting loads. |
| Test Method | Torsion test on bonded segments; measure torque at failure or rotations survived. | |
| Test Equipment | Torque tester, clamping fixture, 37 °C environment. | |
| Test Sample | Torque-exposed segments of delivery/retrieval/conversion systems. | |
| Test Procedure | Fix one end; apply torsion at clinical speed. Test until failure or preset rotations. Record torque/rotations and failure mode. | |
| Importance | Prevent bond failure during rotational manipulation. | |
| Application | Torque-exposed catheter segments. | |
| Filter Tensile Strength | Purpose | Measure tensile strength of filter struts/bonds/joints. |
| Test Method | Tension test on filter components until fracture. | |
| Test Equipment | Universal mechanical tester, micro-gripping fixtures. | |
| Test Sample | Filter components (struts, welded joints, anchors). | |
| Test Procedure | Tension test at constant speed, Record failure force and fracture location. | |
| Importance | Prevent filter fracture/embolism in vivo. | |
| Application | All filter struts/anchors/joints. | |
| Radial Loading Force | Purpose | Measure outward radial force exerted by the filter as a function of diameter. |
| Test Method | Expand filter from min to max indicated diameter; record radial force. | |
| Test Equipment | Radial force tester (iris tester), laser micrometer, 37 °C bath. | |
| Test Sample | Fully deployed filters (full size range). | |
| Test Procedure | Deploy filter in test fixtur. eExpand incrementally to max vessel diameter. Record force-diameter curve. | |
| Importance | Ensure sufficient fixation without caval perforation. | |
| Application | All self-expanding vena cava filters. | |
| Compression Fatigue & Durability | Purpose | Evaluate long-term integrity under cyclic transverse compression (respiration/Valsalva). |
| Test Method | Cyclic compression perpendicular to filter axis; simulate ≥10-year life. | |
| Test Equipment | Fatigue tester, cyclic load controller, mock vessel, PBS bath (37 °C), cycle counter. | |
| Test Sample | Worst-case size/configuration filters (high-stress regions). | |
| Test Procedure | Mount in mock vessel; apply cyclic compression. Run justified cycles (≥10-year equivalent). Inspect for fracture/delamination. | |
| Importance | Prevent fatigue fracture from chronic respiratory motion. | |
| Application | All long-term implant filters. |
Other test:
Migration Resistance: Determine pressure/force to cause cephalad filter migration.
Force to Retrieve: Quantify peak force to retrieve an optional filter using the retrieval system.
Force to Convert: Quantify force to convert a convertible filter (to non-filtering stent).
Clot Trapping: Evaluate ability to capture clinically significant clots without occluding flow.
Corrosion Test: Assess pitting/fretting/crevice/galvanic corrosion of metallic filters.
Fatigue Computational Analysis (FEA): Calculate stress/strain; predict fatigue safety factors (supports bench fatigue).
Related products and device
Related Standard
ISO 25539‑1 applies to endovascular prostheses (stent‑grafts) and their delivery systems. It defines a complete set of mechanical tests covering fatigue, fixation, patency, strength, and dimensional stability. Mainly test include Axial, bending, torsional, Pulsatile Durability, Radial fatigue.
ISO 25539-2 specifies mechanical performance tests as core bench evaluations for stent systems (stent + delivery system + integrated balloon), plus supplementary tests for materials, biology, clinical, sterilization, and packaging. Include the Axial, bending, torsional, Pulsatile Durability, Radial Loading test etc.,
ASTM F2477 designed to evaluate the long-term fatigue durability and radial cyclic deformation resistance of vascular implants under simulated physiological pulsatile loading conditions. It is crucial for simulating the cyclical stresses these medical devices endure inside human blood vessels.
ASTM F3067 establishes in vitro test frameworks to characterize the radial mechanical performance of balloon-expandable vascular stents and self-expanding vascular stents. It quantifies three key indicators: radial strength and collapse pressure for balloon-expandable stents, and chronic outward force (COF) for self-expanding stents.
ASTM F2606 defines quantitative three-point bending procedures to characterize the bending flexibility and stiffness of balloon-expandable vascular stents and stent systems (pre-deployment and deployed states). It is a critical testing protocol in the biomedical engineering field. Since vascular anatomies are naturally curved and tortuous, a stent must be flexible enough to navigate through the delivery pathway (trackability) and conform to the vessel's curvature once deployed without causing vascular trauma . This standard provides the guidelines to measure these mechanical properties accurately.
ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity.
ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. include Axial, bending, torsional, Pulsatile Durability, Radial Loading etc., test.
Based on the ISO/TS 17137 standard the evaluation of mechanical properties is a critical part of the design and safety validation process. Mechanical Evaluation like tension, radial force, Cyclic Fatigue Durability like constant pulsing. Because absorbable implants lose their structural integrity over time through degradation, their mechanical performance must be assessed not just at the time of implantation, but throughout their intended functional lifetime.
ISO 12417-1 specifies requirements for Vascular Device-Drug Combination Products (VDDCPs) (drug-eluting stents, drug-coated balloons, drug-bearing vascular grafts, etc.). It mandates mechanical tests for the device part (DP) (to verify structural/functional integrity) and a suite of drug-related, physicochemical, biological, and clinical tests. Mechanical performance must comply with device-specific standards (ISO 25539-2, ISO 10555-4, ISO 7198) and remain unaffected by the drug-containing part (DCP).
ISO 7198 specifies test and performance requirements for tubular vascular grafts and vascular patches (surgical vascular prostheses). It defines mechanical tests (with full method/equipment/sample details) and other physicochemical, biological, dimensional, preclinical/clinical tests.
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