ISO-10328 Structural Testing of Lower Limb Prosthetics
The ISO-10328 standard outlines structural testing procedures to estimate in vitro behavior of a lower limb prosthetic intended to replace a natural body part’s physical and cosmetic function. ISO-10328 uncovers material defects, mechanical issues, and design deficiencies that could make a product unsafe for temporary or long-term use and lead to further injury and pain to the user. In order to receive FDA approval to commence clinical trials, manufacturers must prove their products meet federal requirements and standards.
Factors
The ATS FoC can assess prosthetics for the lower limbs to determine their reliability as mobility aids and limb replacements. Our ISO/IEC 17025:2017-accredited materials and mechanical testing labs frequently review the impact of design and material properties on critical devices. We can test entire prosthetic structures and individual components, such as sockets, connectors, liners, and the main prosthetic. Limb prosthetics typically include a combination of plastics, lightweight metals, and composites, including:
- Aluminum
- Carbon fiber-reinforced polymers
- Polyethylene
- Polypropylene
- Polyurethane
- Titanium
These materials influence the prosthetic’s resistance to wear and tear or more dramatic degradation over time.
Lower-Limb Prosthetic Cyclic Testing
ATS FoC experts perform cyclic testing on the prosthetic structure and individual components to simulate the loading and unloading forces experienced during walking, sitting, and other daily activities. During a static test, we subject the prosthetic to the harshest loads to assess the ultimate strength. Next, we perform cyclic testing to examine performance under dynamic loads, such as during walking. We can also perform static tests in torsion.
Analysis
ISO-10328 determines fatigue strength, proof strength, and ultimate strength of a prosthesis. After completing static and cyclic tests, our experts analyze the performance and characteristics of the device, offering expert opinions on the material’s resistance to wear and tear, handling of environmental influences, and any need for redesigns to ensure continued function during typical user activities.
About ATS FoC
The ATS FoC provides high-quality consulting engineering, calibration, testing, and inspection services for national and international business clients. We operate several ISO/IEC 17025:2017-accredited labs specializing in mechanical, material, chemical, nondestructive testing, and other service areas. Known for our quick turnaround rate and excellent customer service, we are happy to facilitate the certification of medical devices.
Please call +1 (888) 287-5227 or complete the request form on this page to learn if your product is ISO-10328-compliant.
