Durability and Fatigue Testing

The human body is one of the most challenging environments in which to implant a device. During the development process of medical device, it is very important to assess the ability of the devices to withstand these challenges. Durability and fatigue testing validates lifetimes of medical device by applying physical and repetitive loading such as force, torque, rotation, strain, displacement, and/or pressure in a very similar way to the loading encountered in the human body. Medical device fatigue testing focuses on the nominal stress required for failure after a number of cycles.

STEMart conducts durability and fatigue testing on a variety of implant devices to characterize their behavior during cyclic loading and helps manufacturer bring safe and reliable products to market.

Fatigue Testing Types

S/N fatigue testing: Determine the nominal stress (S) required for failure after a number of cycles (N).

Two sample groups are required for an S/N fatigue testing. One sample group is tested at high peak stress where failure occurs after a low number of cycles. The other sample group is tested at decreasing stress levels where a runout (non-failure) occurs in a specified number of cycles.

Test Capabilities

• Orthopedic Device Fatigue Testing
• Hip implants
• Knee joint replacement
• Spinal implants
• Shoulder implants
• Elbow implants
• Finger implants
• Ankle implants
• Dental implants
• Osteosynthesis
• Bone cement
• Intravascular Device Fatigue Testing
• Stents
• Heart valves

What We Can Do

• Develop the strategy
• Establish protocols
• Validate methods
• Perform data analyses
• Provide regulatory quality final reports

STEMart provides a variety of fatigue testing services to help manufacturers to get a critical understanding of how a material or medical device product will perform in real-world loading scenarios over the course of time. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.