T/CAMDI 043-2020 Additive manufacturing (3D printing) personalized dental implants
T/CAMDI 043-2020 Additive manufacturing (3D printing) personalized dental implants
Basic Information
Scope
Main technical content: This standard specifies the requirements for the product design, materials, quality evaluation, test methods, quality control, manufacturing, heat treatment, sterilization, packaging, and information provided by manufacturers of personalized dental implants primarily processed by 3D printing technology. This standard applies to people with clinical needs and personalized requirements, and is used for the design and manufacture of implantable medical devices that are surgically implanted into the jawbone to support the fixation and stability of dentures. The 3D-printed personalized dental implants referred to in this standard do not include special-design medical devices containing drug components, cells, tissues, and other biologically active substances, such as bio-printed implants.