Fatigue Testing

Our Service

Meditronics (a brand of STEMart) performs fatigue testing that meets international standards, with protocols specifically tailored for diverse medical device applications:

• ISO 7206-4 & ISO 7206-6 – Orthopedic Implant Fatigue Testing
  Method: Simulates gait-induced cyclic loading on femoral stems (ISO 7206-4) and dynamic compression on acetabular cups (ISO 7206-6).
  Test Type: Axial/bending fatigue (hip stems) or compression fatigue (acetabular components).
  Key Metrics: Fatigue life (S-N curve), failure modes, and deformation analysis.
  Applications: Hip prostheses, femoral stems, and pelvic implants.
• ASTM F382 – Metallic Bone Plate Fatigue Testing
  Method: Evaluates bending fatigue resistance under cyclic loads mimicking bone fixation.
  Test Type: 3-point or 4-point bending fatigue.
  Key Metrics: Cycles to failure, crack propagation analysis.
  Applications: Trauma fixation plates, spinal stabilization systems.
• ASTM F1717 – Spinal Implant Construct Fatigue Testing
  Method: Tests spinal rods and pedicle screws under combined compression, bending, and torsion.
  Test Type: Multi-axis fatigue (simulating spinal movement).
  Key Metrics: Construct stiffness, fatigue limit (e.g., 5 million cycles).
  Applications: Spinal fusion devices, interbody cages.
• ISO 25539-1 & ASTM F2477 – Cardiovascular Stent Fatigue Testing
  Method: Pulsatile fatigue testing in simulated blood flow (ISO 25539-1) or accelerated durability testing (ASTM F2477).
  Test Type: Radial pulsation (10–60 Hz) or multi-axis fatigue (ASTM F2942).
  Key Metrics: 400 million cycles (10-year equivalent), stent fracture analysis.
  Applications: Coronary stents, peripheral stents, and stent grafts.
• ISO 14801 – Dental Implant Fatigue Testing
  Method: Axial cyclic loading to simulate chewing forces (up to 2 million cycles).
  Test Type: Dynamic compression fatigue.
  Key Metrics: Fatigue strength, implant-abutment interface stability.
  Applications: Titanium and zirconia dental implants
• ASTM F2118 – Polymer-Based Implant Fatigue Testing
  Method: Tensile or bending fatigue testing for polymer composites.
  Test Type: Constant amplitude fatigue.
  Key Metrics: Fatigue resistance, degradation under cyclic loads.
  Applications: Bioabsorbable sutures, soft tissue meshes.

Why Choose Meditronics?

Meditronics is a trusted partner for medical device manufacturers, offering expertise, cutting-edge technology, and regulatory compliance support:

✔ Regulatory Expertise

Leveraging our regulatory mastery of FDA, ISO, ASTM and EU MDR frameworks, we transform complex testing requirements into actionable protocols and submission-ready reports, minimizing your compliance risks.

✔ State-of-the-Art Equipment

We utilize state-of-the-art fatigue testing systems replicate real-world conditions with precise control over loads, speeds, and environmental factors, ensuring accurate and reliable performance validation.

✔ Fast & Reliable Results

Meditronics delivers detailed report including S-N curves, fracture surface analysis (SEM/FEA correlation), and compliance statements.

✔ End-to-End Support

From material screening to final product validation, we offer pre-test consulting to define critical parameters (load levels, cycle counts); failure analysis to identify design or material weaknesses, and regulatory submission support with test reports aligned to FDA/EU MDR.

Meditronics's fatigue testing services ensure your products withstand real-world conditions. Contact us today to discuss customized testing solutions!