Information on the most widely used ASTM standards within the materials testing industry
Model: UT1307, ISO 5840-1, ISO 5840-2, ISO 5840-3
UT1037 Artificial Heart Valve Durability Testing Machine fully supports AWT, DFM, and RWT tests in accordance with ISO 5840:2021 requirements: dual high-frequency small motors suitable for accelerated AWT and DFM testing; high-torque motor mode performs excellently in low-frequency RWT testing. The UT1037's convenient sample installation and removal design further improves testing efficiency.
UT1037 is controlled and monitored by the Test System software, integrates a 500FPS high-speed camera for simultaneous data and image acquisition, and features a built-in player that supports automatic data naming and archiving.
General Introduction
UT1037 Artificial Heart Valve Durability Testing Machine fully supports AWT, DFM, and RWT tests in accordance with ISO 5840:2021 requirements: dual high-frequency small motors suitable for accelerated AWT and DFM testing; high-torque motor mode performs excellently in low-frequency RWT testing. The UT1037's convenient sample installation and removal design further improves testing efficiency.
UT1037 is controlled and monitored by the Test System software, integrates a 500FPS high-speed camera for simultaneous data and image acquisition, and features a built-in player that supports automatic data naming and archiving.
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. |
RWT: Real-Time Wear Testing | The purpose of Real-Time Wear Testing (RWT) is to closely simulate the physiological load conditions of real patients. Since certain materials have viscoelastic properties, accelerated wear testing may actually result in under-testing the device. Therefore, RWT can be used to identify frequency-dependent failure modes. |
Main features
1, Modular design allows flexible configuration, modification, or upgrade, and supports RWT testing (optional).
2, Up to 6 completely independent testing units (motor drive, pressure detection, heating and temperature control, etc.), which are isolated from each other to prevent vibration interference.
3, Test frequency: 5~60Hz (actual frequency depends on the tested valve; a 27mm mitral valve can reach 30-40Hz in actual measurement).
4, Testing units are made of high-transparency acrylic, with observation windows on the front and back, allowing the valve to be observed from all angles.
5, Each unit is equipped with 2 motors (AWT and DFM modes), supporting high-frequency testing of large-size valves.
6, Equipped with 1 high-speed camera at 500FPS, 720*540 pixels (color or black and white).
7, Snap-in design for quick installation and removal of modules and valves.
8, Fast liquid filling and drainage through a water pump and self-sealing quick couplings, no manual filling required.
9, Software uses closed-loop/feedback control, monitoring test conditions of all units/stations in real time and automatically adjusting to ensure operation exactly according to set test conditions while actively preventing excessive or too-low peak pressure differences.
10, Software can simultaneously collect data and images, automatically archive them, and has a built-in player to review images.
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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
| Number of Independent Units | 6 |
| Test Modes | AWT, DFM, RWT (optional) |
| High-Speed Camera | 720*540, 500FPS |
| Pressure Measurement Range | ±300 mmHg |
| Pressure Measurement Accuracy | ±2% FS |
| Test Frequency Range | 30 ~ 3600 bpm (0.5~60 Hz) |
| Count Range | 1 ~ 1 billion cycles |
| Test Fluid Temperature Control Range | Room Temperature ~ 50℃ |
| Temperature Control Accuracy | ±1℃ |
| Applicable Valve Types | Mechanical valves, biological valves, interventional valves, polymer valves |
| Applicable Valve Diameter | φ19~70mm (standard), 90mm (custom) |
| Operating Environment | Temperature 15 ~ 35℃, Humidity ≤ 85%, no condensation |
| Test Fluid Types | Physiological saline, glycerol-water mixture, or blood |
Heart valve test samples
RWT test 200BPM 25mm Mechanical bileaflet valve |
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| AWT test 2400BPM 27mm Surgical mitral valve |
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Integrated camera system, including a 500FPS high-speed camera, lift stand, ring LED light, and software video functions |
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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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