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.
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
- Fatigue Testing Lab
- Implant Testing
- Material Testing Laboratory
- Material Device Regulatory Compliance Testing
- Medical Device Testing
- Medical Device Testing Certification
- Medical Device Materials Testing
- Medical Device Materials Testing Consulting
- Medical Device Mechanical Testing
- Medical Device Mechanical Testing Regulations
- Medical Device Performance Testing
- Medical Device Product Testing
- Medical Device Reliability Testing
- Medical Device Standards Testing
- Medical Device Standards Testing Certifications
- Medical Device Testing Companies
- Medical Device Testing Services
- Medical Device Testing Lab
- Medical Implant Testing Lab
- Orthopedic Device Testing
- Prosthetic Testing
- Prosthetic Testing Services