Information on the most widely used ASTM standards within the materials testing industry
Model: UT1307E, ISO 5840-1, ISO 5840-2, ISO 5840-3
UT1037E Heart Valve Accelerated Durability Tester, in accordance with the latest ISO 5840 series standards, is an AWT and DFM test system for evaluating transcatheter and surgical aortic, mitral, pulmonary and tricuspid valves.
The real-time closed-loop motion control system, combined with innovative compliant chamber structures, significantly enhances the device's intelligence, stability, and ease of operation. The entire process from control and acquisition to computation, analysis, and recording is managed by our proprietary, self-developed software.
General Introduction
UT1037E Heart Valve Accelerated Durability Tester, in accordance with the latest ISO 5840 series standards, is an AWT and DFM test system for evaluating transcatheter and surgical aortic, mitral, pulmonary and tricuspid valves.
The real-time closed-loop motion control system, combined with innovative compliant chamber structures, significantly enhances the device's intelligence, stability, and ease of operation. The entire process from control and acquisition to computation, analysis, and recording is managed by our proprietary, self-developed software.
AWT: Accelerated Wear Testing
Accelerated wear testing of artificial heart valves is a crucial reliability verification method in the field of cardiovascular medical devices. Its core value lies in simulating the cyclical loads that the valves endure over a long period in the human physiological environment, allowing the prediction of their durability after implantation through accelerated testing.
DFM: Dynamic Failure Mode Testing
The dynamic failure mode (DFM) testing of heart valve prostheses is used together with accelerated wear testing (AWT) to provide a comprehensive assessment of durability. Since AWT is a 'pass/fail' testing method, it means that the samples are intended to pass the test, whereas DFM testing is a 'failure mode' testing method designed to characterize potential durability-related failure modes.
Application: Suitable for artificial valves, valve clips, and occluders.
Main features
1), The system accommodates both accelerated wear testing (AWT) and dynamic failure mode testing (DFM).
2), The system offers two running modes: Autopilot Stroke and Fixed Stroke, accommodating various testing requirements.
3), In Autopilot Stroke mode, precise close-loop control over the closing differential pressure and ISO% time ratio minimizes test duration.
4), Intelligent operation minimizes operator-induced errors and eliminates the need for additional fluid or air replenishment.
5), TEST software provides the user-friendly operation and comprehensive data recording modes.
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ISO 5840-1 Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements
ISO 5840-2 Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes
ISO 5840-3 Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5910 Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices
If the valve is stented to support the leaflets, the below standard for testing the stent device:
ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
ISO 25539-1 Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
ISO 7198 Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches
Main Technical Specification
| Model | UT1037E |
| Sample Capacity | Up to 6, Independently Controlled |
| Sample Size | Std. 48mm (Custom Sizes Available, up to 83mm) |
| Operation Modes | Autopilot Stroke and Fixed Stroke |
| Drive Waveform | Sine |
| Frequency | Up to 50Hz, Suggested 15~25Hz |
| Test Medium | Purified Water, Saline Solution or Phosphate Buffered Saline(PBS) |
| Fluid Temperature Control | Room Temperature to 42℃, ±2℃ |
| Pressure Range and Accuracy | -100 to 700mmHg, ±2mmHg |
| Others | Common Accessories, Fixture Customization Available |
Standard
ISO 5840 test standard is crucial, it is the definitive global standard for heart valve prostheses. This standard provides a structured, risk-based framework to ensure the safety, performance, and durability of these life-sustaining devices.
The standard is divided into several parts, with the most critical for testing being:
ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements.
ISO 5840-2:2021 - Part 2: Surgically implanted heart valve substitutes.
ISO 5840-3:2021 - Part 3: Transcatheter heart valve systems.
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