Heart Valve & Valve Repair Device Testing
Experts from BDC Laboratories actively participate in the ISO Cardiac Valve Prosthesis Committee (WG1) responsible for the ISO 5840 heart valve standard and the ISO 5910 heart valve repair device standard. Drawing on a deep understanding of cardiovascular fluid dynamics, heart valve testing requirements, and regulatory landscape, BDC Laboratories offers specialized expertise in hydrodynamic performance testing, accelerated wear testing (AWT), and dynamic failure mode (DFM) testing for both heart valve prostheses and cardiac valve repair devices.
As experts in testing of endovascular stents, BDC Laboratories performs heart valve frame fatigue and structural assessments for transcatheter heart valves.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ heart valve prosthesis testing and cardiac valve repair device testing capabilities, per the published guidance documents, appear below.
Complete Testing Solution
Our team supports all aspects of device evaluation, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Scalable Test Program
We execute all test programs according to the data’s application, ranging from abbreviated early-stage development studies to final, formal regulatory submission studies.
Relevant Standards
ISO Standards
ISO 5840-1, 5840-2, & 5840-3
- Pulsatile Hydrodynamic Evaluation
- Steady Flow Hydrodynamic Evaluation
- Accelerated Wear Durability
- Dynamic Failure Mode Testing
- Real-time Wear Testing
- Structural Component Fatigue Assessment (frame & commissures)
- Corrosion Assessment
- MRI Compatibility
- Delivery System Assessments
ISO 5910
- Pulsatile Hydrodynamic Evaluation
- Accelerated Wear Durability
- Structural Component Fatigue Assessment (frame & commissures)
- Corrosion Assessment
- MRI Compatibility
- Delivery System Assessments
ASTM Standards
- F2052: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- F2079: Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
- F2119: Evaluation of MR Image Artifacts from Passive Implants
- F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- F2182: Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (MRI)
- F2213: Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- F2477: In vitro Pulsatile Durability Testing of Vascular Stents
- F2503: Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- F2942: In vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
- F3044: Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- F3067: Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
Testing Backed by ISO/IEC 17025 Accreditation
At BDC Laboratories, quality is central to everything we do. We maintain ISO/IEC 17025:2017 accreditation and comply with relevant portions of 21 CFR Part 58 (Good Laboratory Practices), among other U.S. and international governing standards. With a comprehensive quality management system, we ensure service and product integrity with a focus on regulatory compliance and continuous improvement.
Why BDC?
Built Around Your Goals
From first conversation to final report, we collaborate with your team to design and execute accredited testing programs aligned with your device goals and regulatory requirements.
Regulatory-Ready, On Time
With ISO/IEC 17025:2017 accreditation and 40+ years of industry experience, we deliver precise, regulatory-ready results on timelines that keep your project moving.
Reliable, Responsive Partnership
You’ll work with project managers who stay engaged throughout the process. They’re available for questions, quick to respond, and focused on keeping your program on track.
Explore More
VDT | Heart Valve Durability System
RWT | Heart Valve Real-Time Wear System
HDTi | Heart Valve Pulse Duplicator Test System
PQT | Heart Valve Production Quality Test System
Connect with an Expert at BDC
Provide a few details about your project, and a BDC Laboratories team member will respond within 2 business days to advise on next steps.