ASTM F1541 ESFD Testing
The Applied Technical Services Family of Companies (FoC) evaluates external fixation devices to ensure their compliance with ASTM F1541 ESFD testing standards. External skeletal fixation devices, or ESFDs, stabilize fractured bones, aiding treatment and healing. Our medical device testing lab assesses the safety and effectiveness of ESFDs in accordance with ASTM F1541 to ensure our client’s products are FDA-compliant and eligible for clinical use.
What is ASTM F1541?
The American Society for Testing and Materials developed ASTM F1541 as an outline for those characterizing skeletal medical devices and their various mechanical properties and design elements. The F1541 specification is divided into the following four annexes:
Annex 1: External Fixators
During Annex 1, technicians use torsional or axial load applications to test the device’s external fixator connections.
Annex 2: External Skeletal Fixator Connectors
Annex 2 measures external skeletal fixator joints’ durability, stiffness, and part dynamics.
Annex 3: Compressive Properties
During Annex 3, technicians evaluate the assembly’s yield strength, ultimate strength, and chord stiffness.
Annex 4: External Skeletal Fixator Joints
Annex 4 applies linear and angular load conditions and static tests to devices to determine the device’s stiffness and strength
Our Medical Device Testing Labs
Medical devices are instruments, machines, and implants that aid in the diagnosis, treatment, and prevention of injuries and illnesses. These devices are an essential element of healthcare, and our medical device testing labs help ensure that our client’s medical devices comply with ASTM and FDA guidelines. Our experienced engineers and technicians work closely with clients to develop strategies that directly address our client’s demands promptly and professionally. We offer numerous medical device testing services, including, but not limited to, the following:
- Driving Torque Testing
- Fatigue Testing
- Non-Standard Testing
- Simulation Testing
- Tensile Testing
- Torsion Testing
Our Commitment to Quality
The Applied Technical Services Family of Companies is a reputable enterprise offering a wide range of services that benefit commercial and industrial businesses. Our A2LA-accredited labs specialize in consulting engineering, testing, and inspection services and help our clients develop and improve their products for an affordable price. Please consider the ATS FoC for your ASTM F1541 ESFD testing needs and submit an online service request today.
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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