Home >> Products >> Industrial Specialized Testing >> Food & Medical Device >> Heart Valve Accelerated Durability Tester, Occluder Fatigue Tester
Heart Valve Accelerated Durability Tester

Heart Valve Accelerated Durability Tester, Occluder Fatigue Tester

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

  • Features
  • High-Speed Imaging and Playback
  • Reference standard

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.

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

ModelUT1037E
Sample CapacityUp to 6, Independently Controlled
Sample SizeStd. 48mm (Custom Sizes Available, up to   83mm)
Operation ModesAutopilot Stroke and Fixed Stroke
Drive WaveformSine
FrequencyUp to 50Hz, Suggested 15~25Hz
Test MediumPurified Water, Saline Solution or Phosphate   Buffered Saline(PBS)
Fluid Temperature ControlRoom Temperature to 42℃, ±2℃
Pressure Range and Accuracy-100 to 700mmHg, ±2mmHg
OthersCommon Accessories, Fixture Customization   Available


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.

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.