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Heart Valve Durability Testing Machine

Heart Valve Durability Testing Machine

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

  • Features
  • Fully Functional Test System Software
  • High-Speed Imaging and Playback
  • Reference standard

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.

Heart Valve Durability Testing Machine
Heart Valve Durability Testing Machine

Heart Valve Durability Testing Machine


Heart Valve Durability Testing Machine
Heart Valve Durability Testing Machine

Heart Valve Durability Testing Machine


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 Units6
Test ModesAWT, DFM,     RWT (optional)
High-Speed Camera720*540,   500FPS
Pressure Measurement Range±300 mmHg
Pressure Measurement Accuracy±2% FS
Test Frequency Range30 ~ 3600 bpm (0.5~60 Hz)
Count Range1 ~ 1 billion cycles
Test Fluid Temperature Control RangeRoom Temperature ~ 50℃
Temperature Control Accuracy±1℃
Applicable Valve TypesMechanical valves, biological valves, interventional valves, polymer valves
 
 
Applicable Valve Diameterφ19~70mm (standard), 90mm (custom)
Operating EnvironmentTemperature 15 ~ 35℃, Humidity ≤ 85%, no condensation
Test Fluid TypesPhysiological saline, glycerol-water mixture, or blood


Heart valve test samples


RWT test 200BPM 25mm Mechanical bileaflet valve

Heart Valve Durability Testing Machine
AWT test 2400BPM 27mm Surgical mitral valve
Heart Valve Durability Testing Machine

Integrated camera system, including a 500FPS high-speed camera, lift stand, ring LED light, and software video functions

Heart Valve Durability Testing Machine


Standard

ISO 5840 Heart valve prostheses testing methods

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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Beijing United Test Co., Ltd.