Quality

Element22 GmbH has a certified quality management system according to the international standard EN ISO 13485 and ISO 9001. Our certificates can be downloaded below:

ISO 13485 certificate

ISO 9001 certificate

The implantable Titanium MIM components are approved around the globe for implantation into the human body. These parts are manufactured and certified according to the following ASTM standards:

  • ASTM F2989-13: Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
  • ASTM F2885-11: Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

In addition, our Ti MIM material has been tested for biocompatibility, toxicity, geometric repeatability, mechanical and chemical material characteristics, surface finish, density, microstructure, fatigue life, stress corrosion cracking, weldability and more.