Inferior Vena Cava Filter Testing

BDC Laboratories’ personnel are active members of the AAMI/ISO 25539 Standard Workgroup (WG3), which is responsible for the development of ISO 25539-3 for Vena Cava filter testing and evaluation. From this first-hand experience in the drafting of the evaluation expectations, BDC offers comprehensive vena cava filter and intravascular filter testing programs. In addition to the tests outlined below for our capabilities, the BDC team excels in developing custom test methods specific to novel and unique filter technologies.

Based on our extensive knowledge of testing and evaluating vena cava filter technology, BDC can offer a complete testing solutions as presented below. Our group is capable of supporting all aspects of the evaluation, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. Moreover, all test programs can be executed at a level consistent with the data’s application to optimize efficiency in time and cost, ranging from abbreviated early stage development studies to final, formal regulatory submission studies.

ISO Standards


  • 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