Durability testing plays a critical role in validating the performance and safety of medical devices. It also serves as a key component in regulatory submissions. During this process, devices undergo comprehensive fatigue characterization to predict their lifetime behavior. These insights inform design optimization and ensure the approval of reliable, life-changing medical solutions. In our discussion, we’ll explore common standards-based test methods, including relevant example data.
Topics discussed during this webinar include:
- Fatigue to Fracture Methodology (ASTM F3211)
- Thermal Cycling of Shape Memory Stents (ASTM E3097)
- In Vitro Pulsatile Durability of Stents (ASTM F2477)
- Cardiac Valve Prostheses (ISO 5840)
- Dynamic Fatigue Test of Dental Implants (ISO 14801)
- Testing Breast Implants (ISO 14607)
