Vena Cava Filter Testing
With years of industry experience, experts from BDC Laboratories actively participate in the AAMI/ISO 25539 Standard Workgroup (WG3), which oversees the development and revision of ISO 25539-3 for vena cava filter testing and evaluation. This technical context guides BDC Laboratories’ comprehensive vena cava filter and intravascular filter testing programs.
Service Highlights
Custom Evaluation Options
In addition to the noted tests, BDC Laboratories excels in developing custom test methods specific to novel and unique filter technologies.
Standards-Driven Excellence
Our vena cava filter evaluation capabilities, per the published guidance documents, appear below.
Complete Testing Solution
BDC Laboratories supports all aspects of 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
25539-3
Implant
- Clot Trapping
- Fatigue/Durability
- Filter Dimensional Verification
- Filter Tensile Strength
- Migration Resistance
- Radial Force
- Visual Inspection
Endovascular System
- Dimensional Verification
- Simulated Use
- Force to Deploy
- Force to Retrieve/Convert
Delivery System
- Tensile Strength
- Torsional Bond Strength
- Catheter Burst Strength
- Power Injection
ASTM Standards
- F2052: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- 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
- 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
FDA Guidance
Cardiovascular Intravascular Filters
- Simulated Deployment
- Introducer/Sheath Suitability
- Clot Trapping Ability
- Filter Fracture
- Caval Perforation/Filter Migration
- MRI Compatibility
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.
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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.