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 per 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 ISO/IEC 17025-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.
