Vascular Graft Testing
With years of industry experience, experts from BDC Laboratories actively participate in the AAMI/ISO 7198 Standard Workgroup (WG3) committee responsible for drafting the standard for tubular vascular prostheses. Our expertise encompasses a vast array of vascular graft technologies including textile, biological, ePTFE, polyurethane, and arterial-venous (A/V) access grafts.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ vascular graft evaluation capabilities, per the published guidance documents, appear below.
Complete Testing Solution
Our team 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
7198
- Visual Inspection
- Integral Water Permeability / Leakage
- Longitudinal Tensile Strength
- Usable Length
- Wall Thickness
- Dynamic Compliance
- Porosity
- Water Entry Pressure (WEP)
- Burst Strength
- Relaxed Inner Diameter
- Suture Retention Strength
- Water Permeability
- Circumferential Tensile Strength
- Burst Strength after Repeated Puncture
- Pressurized Inner Diameter
- Kink Diameter / Radius
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
Testing Services
Testing Equipment
Silicone Solutions
Simulation Solutions
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.