This standard specifies terms and definitions, expected performance, design attributes, requirements, test methods, cleaning, manufacturing, sterilization and packaging information for additively manufactured tantalum spinal prostheses. This standard applies to tantalum metal prostheses manufactured by additive manufacturing to replace human spinal vertebral bodies, achieve fixation and fusion between vertebral bodies, and reconstruct the stable structure of the spine. This standard applies to tantalum metal prostheses manufactured by powder bed fusion additive manufacturing processes using lasers or electron beams as energy sources. Spinal prostheses manufactured by other additive manufacturing processes and materials may refer to the applicable specific content.
T/CAMDI 067-2021 history
2021T/CAMDI 067-2021 Additive manufacturing of tantalum metal spinal prosthesis