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Home >> Application >> By Standard >> ISO >> ISO 20000 + >> ISO 25539-1 Test methods of endovascular prostheses, vascular stents grafts

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

ISO 25539‑1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

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. In ISO 25539-1, mechanical testing (bench testing and analytical testing) is a key step to ensure that implants can deploy properly, remain stable over the long term, and avoid damage in complex vascular environments. 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.

1, Fatigue & Durability Tests

Test	Test methods and requirement	Test Equipment
Radial Fatigue & Durability	Test Method: Cyclic radial deformation simulating cardiac pulsatile pressure; evaluate long‑term radial structural integrity. Test requirement: Run a minimum of 380 million cycles (simulating 10‑year service life). Importance: Prevent fatigue rupture and ensure long‑term structural stability under pulsatile blood pressure. Application: Abdominal/thoracic aortic stent‑grafts.	Radial fatigue tester, 37±2°C constant‑temperature fluid bath.
Axial Fatigue & Durability	Test Method: Cyclic axial elongation and shortening to simulate physiological motion. Procedure: Apply cyclic axial displacement → run target cycles → inspect for fracture or separation. Importance: Avoid axial fatigue failure of modular components. Application: Stent‑grafts in mobile anatomy (aorta, iliac arteries).	Axial fatigue tester, 37±2°C environment,
Bending Fatigue & Durability	Test Method: Cyclic bending (column buckling, mandrel bending, or arc bending). Sample: Sterilized prosthesis. Procedure: Deploy in mock artery (optional pressurization to prevent lumen flattening) → apply cyclic bending → inspect for kinking or fracture.	Bending fatigue testing machine
Torsional Fatigue & Durability	Test Method: Cyclic torsion around the longitudinal axis. Sample: Sterilized prosthesis. Procedure: Fix one end, apply cyclic torsion to the other → inspect for structural damage. Application: Stent‑grafts in torsional vascular environments.	Torsion fatigue tester.
Active Fixation Fatigue & Durability	Test Method: Cyclic loading on barbs/hooks/pins to test retention strength. Sample: Prosthesis with active fixation (barbs/hooks). Procedure: Engage fixation in mock artery → apply cyclic load → inspect for fixation fracture or pull‑out.	Fatigue testing machine 37±2°C environment Bath.

2. Strength Mechanical Tests

Test	Test methods and requirement	Test Equipment
Burst Strength	Test Method: Internal pressurization until graft rupture (per ISO 7198). Sample: Sterilized prosthesis or graft material. Procedure: Seal ends → pressurize → record burst pressure. Importance: Prevent graft rupture and Type IIIb endoleak.	Pressurre testing machine with fixture
Seam Strength	Test Method: Tensile test of factory‑made graft seams (ISO 7198). Sample: Graft seam specimens. Procedure: Tension until seam failure → record peak force.	Tensile tester
Longitudinal Tensile Strength	Test Method: Axial tension of graft material. Sample: Graft strips. Procedure: Tension until failure → record maximum force. Importance: Prevent tearing during delivery and deployment.	Tensile tester with suitable fixture
Graft‑to‑Fixation Connection Strength	Test Method: Tensile pull test between graft and fixation system. Sample: Prosthesis with discrete fixation. Procedure: Pull graft and fixation apart → record force and failure mode. Importance: Prevent graft‑stent separation. Application: Stent‑grafts with separate fixation structures.	Tensile tester with special grips
Strength after Repeated Puncture	Test Method: Repeated dialysis needle puncture followed by strength test (ISO 7198). Sample: Vascular‑access prosthesis. Procedure: Repeated cannulation → measure residual strength. Importance: Maintain integrity after repeated dialysis access. Application: Vascular access grafts.	Puncture fixture + tensile tester.

3. Other Test

Test	Test methods and requirement	Test equipment
Resistance to Kinking (Flexibility)	Test Method: Determine the minimum bending radius without kinking (per ISO 7198). Sample: Full‑length or segmented prosthesis. Procedure: Bend until kink occurs → record minimum radius. Importance: Maintain patency in tortuous vessels.	Kink‑test fixture.
Crush / Compression Resistance	Test Method: Apply perpendicular or radial load; measure force at specified deformation. Sample: Balloon‑expandable (crush) / self‑expanding (compression) prosthesis. Procedure: Apply load → measure permanent deformation after unloading. Importance: Prevent external compression leading to lumen obstruction.	Compression tester with flat platens or cylindrical fixtures.
Radial Force (Self‑Expanding Prostheses)	Test Method: Measure outward radial force at different diameters. Sample: Sterilized self‑expanding prosthesis. Procedure: Deploy in tester → adjust diameter from min to max clinical range → record force curve. Importance: Ensure sufficient vessel apposition and resist collapse.	Radial force testing machine
Migration Resistance	Test Method: Measure the force or pressure required to cause prosthesis migration. Sample: Sterilized prosthesis with minimum anchoring length per IFU. Procedure: Deploy in mock artery → apply axial pull (50–200 mm/min) or pulsatile pressure → record peak force/pressure at migration.	Universal mechanical tester, pressure fixture, mock artery simulating landing zones.
Separation Force for Overlapping	Test Method: Measure force to separate overlapped or modular components. Sample: Deployed overlapping prostheses (minimum overlap per IFU). Procedure: Create clinical overlap → apply axial pull → record peak separation force.	Universal mechanical testing equipment

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

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 –

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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