This standard specifies the definition, materials, performance requirements and applicable test methods, quality control, manufacturing, cleaning, sterilization, expiry date and packaging of additively manufactured (3D printed) oral metal implants, and information provided by the manufacturer. Requirements, this standard does not cover implant accessories. This standard applies to products whose chemical composition complies with GB/T13810-2017 "Titanium and titanium alloy processing materials for surgical implants" or ISO5832-2, ISO5832-3, ISO5832-11 or ASTM F67-00, ASTM F136-12, ASTM Titanium and titanium alloy materials for surgical implants in F1295 and ASTM1472; other metal powders that have been verified and whose biological evaluation complies with the regulations of GB/T16886.1-2011, and metal oral cavity made by additive manufacturing (3D printing) process Implants.
T/CAMDI 044-2020 history
2020T/CAMDI 044-2020 Additive Manufacturing (3D Printing) Oral Metal Implants