Medical Device Corrosion Testing
Corrosion evaluation plays an important role in any medical implant development and evaluation strategy. Electrochemical corrosion testing per ASTM F2129 assesses pitting corrosion risk, while testing per ASTM F3044 efficiently evaluates the potential for galvanic corrosion between dissimilar implanted metals.
Interpreting electrochemical corrosion results and meeting regulatory expectations presents challenges. BDC Laboratories is experienced in evaluating corrosion resistance for numerous implant types and helps clients navigate requirements from the U.S. FDA and other regulatory bodies.
Service Highlights
Standards-Driven Excellence
Based on our extensive knowledge of corrosion testing, BDC Laboratories offers complete corrosion assessment solutions, as outlined below.
Complete Testing Solution
Our team supports all aspects of medical device corrosion assessment, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Relevant Standards
ISO Standards
- 25539-1, Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
- 25539-2, Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
- 25539-3, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
- 5840-1, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
- 5840-2, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
- 5840-3, Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
- 5910, Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
ASTM Standards
- F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- F3044: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
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.