Information on the most widely used ASTM standards within the materials testing industry
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
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
| Model | UTCA-VSTP6 |
| Sample Capacity | Up to 6 |
| Mock Vessel Size | Allowable Diameter Range: 2 to 50mm, Max. Length: 230mm |
| Allowable Axial Amplitude | 0.5 to 13mm, Accuracy of ±0.1mm |
| Allowable Frequency | 1~50Hz |
| Test Medium | Purified Water, Saline Solution |
| Fluid Temperature Control | Room Temperature to 42℃, ±2℃ |
| Others | Common Accessories, Fixture Customization Available |
Standard
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.
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 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.
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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