Home >> Products >> Dynamic Fatigue Testing Machines >> Medical Implants Fatigue Test >> Vascular Stent Uniaxial Tension Durability Testing Machine
Vascular Stent Push-pull Durability Tester

Vascular Stent Uniaxial Tension Durability Testing Machine

Model: UTCA-VSTP6, ISO 25539, ASTM F2942.

UTCA-VSTP6 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. The system comes standard with 6 synchronously controlled test stations. These stations feature changeable fixtures to accommodate mock vessels of various lengths and diameters, and support custom fixtures for specialized mock vessels with complex geometric profiles (e.g., bifurcated).

General Introduction

UTCA-VSTP6 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. The system comes standard with 6 synchronously controlled test stations. These stations feature changeable fixtures to accommodate mock vessels of various lengths and diameters, and support custom fixtures for specialized mock vessels with complex geometric profiles (e.g., bifurcated).

Through an innovative "internal test fluid circulation mechanism", the system provides precise control over test fluid pressure and temperature. The entire process (from control and acquisition to computation, analysis, and recording) is managed by our proprietary, self-developed TEST software.


Application: Suitable for vascular stents, surgical stents, etc.

Key Features

  • Main features
  • Standard


1), Vertical orientation design for ergonomic operation and compatibility with various stent designs.

2), Modular design, featuring easy installation and operation, and supports custom modifications.

3),  An internal fluid circulation system with precise pressure and temperature control for enhanced in-vivo condition simulation.

ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

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

ISO 25539-2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters.



Main Technical Specification

ModelUTCA-VSTP6
Sample CapacityUp to 6
Mock Vessel SizeAllowable Diameter Range: 2 to 50mm, Max.   Length: 230mm
Allowable Axial Amplitude0.5 to 13mm, Accuracy of ±0.1mm
Allowable Frequency1~50Hz
Test MediumPurified Water, Saline Solution
Fluid Temperature ControlRoom Temperature to 42℃, ±2℃
OthersCommon Accessories, Fixture Customization   Available


Standard

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. 

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 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. 

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.

Require More Customized Solutions?

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you
Customize Now

Beijing United Test Co., Ltd.