T/CAMDI 044-2020 Additive Manufacturing (3D Printing) for Dental Metal Implants
T/CAMDI 044-2020 Additive Manufacturing (3D Printing) for Dental Metal Implants
Basic Information
Scope
Main technical content: This standard specifies the definition, materials, performance requirements, and corresponding test methods of oral metal implants for additive manufacturing (3D printing), as well as quality control, manufacturing, cleaning, sterilization, shelf life, packaging, and requirements for information provided by manufacturers. This standard does not include implant accessories. This standard applies to metal oral implants manufactured using materials that comply with the chemical composition requirements of GB/T 13810-2017 "Titanium and Titanium Alloy Processing Materials for Surgical Implants" or ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM F67-00, ASTM F136-12, ASTM F1295, ASTM 1472 for surgical implant materials; other metal powders that have been verified and meet the biological evaluation requirements specified in GB/T 16886.1-2011; and metal oral implants manufactured using additive manufacturing (3D printing) technology.