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ISO 25539-3 Test methods of cardiovascular implants - Vena cava filters

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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. 

ISO 25539-3 Test methods of cardiovascular implants - Vena cava filters


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.

TestItemDetails
Tensile Bond StrengthPurposeMeasure tensile strength of joints/connections in delivery/retrieval/conversion systems.
Test MethodTension test on bonded joints until failure; record peak failure force.
Test EquipmentUniversal mechanical tester, gripping fixtures, 37 °C incubator.
Test SampleSystem 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.

ImportancePrevent   component separation during clinical use.
ApplicationAll delivery/retrieval/conversion system joints.
Torsional Bond StrengthPurposeEvaluate torsional strength of bonds under clinical twisting loads.
Test MethodTorsion test on bonded segments; measure torque at failure or rotations survived.
Test EquipmentTorque tester, clamping fixture, 37 °C environment.
Test SampleTorque-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.

ImportancePrevent bond failure during rotational manipulation.
ApplicationTorque-exposed catheter segments.
Filter Tensile StrengthPurposeMeasure tensile strength of filter struts/bonds/joints.
Test MethodTension test on filter components until fracture.
Test EquipmentUniversal mechanical tester, micro-gripping fixtures.
Test SampleFilter components (struts, welded joints, anchors).
Test ProcedureTension test at constant speed, Record failure force and fracture location.                                                   
ImportancePrevent filter fracture/embolism in vivo.
ApplicationAll filter struts/anchors/joints.
Radial Loading ForcePurposeMeasure outward radial force exerted by the filter as a function of diameter.
Test MethodExpand filter from min to max indicated diameter; record radial force.
Test EquipmentRadial force tester (iris tester), laser micrometer, 37 °C bath.
Test SampleFully deployed filters (full size range).
Test Procedure

Deploy filter in test fixtur.

eExpand incrementally to max vessel diameter.

Record force-diameter curve.

ImportanceEnsure sufficient fixation without caval perforation.
ApplicationAll self-expanding vena cava filters.
Compression Fatigue & Durability              PurposeEvaluate long-term integrity under cyclic transverse compression (respiration/Valsalva).
Test MethodCyclic compression perpendicular to filter axis; simulate ≥10-year life.
Test EquipmentFatigue tester, cyclic load controller, mock vessel, PBS bath (37 °C), cycle counter.
Test SampleWorst-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.

ImportancePrevent fatigue fracture from chronic respiratory motion.
ApplicationAll 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

ASTM F2942 Vascular Stent Uniaxial Tension Durability Testing Machine

Vascular Stent Uniaxial Tension Durability Testing Machine is designed to perform accelerated axial fatigue and durability testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic axial loading.

ASTM F2942 Vascular Stent Bending Durability Tester

Vascular Stent Bending Durability Tester is designed to perform accelerated bending fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic bending loading.

ASTM F2942 Vascular Stent Torsion Durability Tester

UTCA-VST6 Vascular Stent Torsion Durability Tester is designed to perform accelerated torsional fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic torsional loading.

ASTM F3211 Multi‐Axis Fatigue Torsional & Bending testing system

Multi‐Axis Fatigue Torsional & Bending testing system understake this task, used to check the torsion and bending, tension test for the Intramedullary lengthening nail/Intramedullary leg lengthening implants nails.

ASTM F2477 Vascular Stent Radial Pulsatile Fatigue Testing System

Radial Pulsatile Accelerated Durability Tester is designed to perform accelerated pulsatile durability testing on vascular implants such as stents or valve frames, in accordance with relevant requirements of ISO 25539 and ASTM F2477.

ASTM F3036 Single column universal testing machine

A single column tensile tester is a sophisticated material testing instrument designed for measuring mechanical properties of various materials under tension, compression, bending, shear, and other loading conditions. As the name suggests, it features a single vertical column supporting a moving crosshead that applies force to test specimens.

ASTM F3067 Segmented head stent radial loading compression test fixture

Segmented head stent radial loading compression test fixture is a specialized designed to evaluate the radial mechanical properties of vascular stents, including radial strength, chronic outward force (COF), collapse pressure, and radial stiffness. Conform with ASTM F3067, ISO 25539-2

ASTM F2606 Three-Point Bending Test fixture for Vascular Stent

Three-Point Bending Test fixture for Vascular Stent is a specialized mechanical testing instrument designed to evaluate the flexural properties of balloon-expandable vascular stents and stent system. Conform with ASTM F2606, ISO 25539-2.

Related Standard

ISO 25539-1 Test methods of endovascular prostheses, vascular stents grafts

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 Test methods endovascular devices - vascular stents

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 Test for in-vitro Pulsatile Durability Testing of Vascular Stents

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 Radial Loading Test of Vascular Stents

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 Three-Point Bending Test for Balloon-Expandable Vascular Stents and Stent Systems

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 Vascular Implants Axial, bending, torsional and compression durability testing

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 F3036 Testing of Absorbable Stents

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. 

ISO 17137 Test Methods of cardiovascular absorbable implants

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 Test Methods for Cardiovascular implants and extracorporeal systems

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 Mechanical Tests and Other Evaluations for Vascular Implants

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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