The Applied Technical Services Family of Companies (FoC) evaluates the functionality of total wrist implants in accordance with the ASTM F1357 articulating total wrist implant testing standard. Total wrist implants offer much-needed solutions to patients who experience chronic wrist pain from injuries, infections, or chronic conditions. Total wrist implant prototypes undergo extensive evaluations to ensure their ability to mimic the complex motions within the wrist joints. Our medical device testing facilities conduct ASTM F1357-compliant services that aid the development of wrist implants.
What is ASTM F1357?
The American Society for Testing and Materials developed ASTM F1357 as a guideline for manufacturers seeking to approve their total wrist implant prototypes for clinical use. The standard addresses the carpal and radial components required for functioning articulation. The functioning articulation of a total wrist implant refers to the implant’s ability to grant the user adequate motor skills and coordination. The ASTM F1357 articulating total wrist implant testing standard specifies the inclusion of several materials in the manufacturing process of total wrist implants, including:
- Cobalt-28chromium-6molybdenum alloy
- Unalloyed titanium
- Wrought cobalt-20chromium-15tungsten-10nickel alloy
- Wrought cobalt-20nickel-20chromium-3.5molybdenum-3.5tungsten-5iron
- Wrought 35cobalt-35nickel-20chromiu-10molybdenum alloy
- Wrought titanium-6aluminum-4vanadium extra low interstitial alloy
About Our Medical Device Testing Capabilities
The ATS FoC has the expertise and equipment to conduct comprehensive medical device testing. Our medical device testing services help clients adhere to industry-wide regulatory requirements and interational quality standards such as ASTM F1357. We offer numerous medical device tests, including:
- Abrasion Testing
- Axial Compression Testing
- Fatigue Testing
- Life Cycle Testing
- Tensile Testing
- Torque Testing
The ATS FoC Experience
The ATS FoC houses numerous ISO 17025 and ISO/IEC 17025:2017 accredited labs with industrial-grade testing, inspection, and analysis equipment. Our trusted employees work closely with clients to develop strategies that directly address their demands while remaining compliant with industry standards. It’s our mission to foster positive experiences for our clients by providing the following:
- Professional Service
- Quick Turn-Around Times
- Competitive Prices
- Ethical Business Practices
Please call +1 (888) 287-5227 or submit an online request for an estimate regarding our ASTM F1357 services or to learn more about our medical device testing labs.
