What performance indicators need to be specified in the technical requirements for additively manufactured artificial vertebral body products?
According to the "Technical Review Guidelines for the Registration of 3D Printed Artificial Vertebral Body Products" and the "Guidelines for the Preparation of Technical Requirements for Medical Device Products," additively manufactured artificial vertebral body products usually need to include performance indicators such as microstructure, surface quality, internal defects, mechanical properties (like hardness and stiffness), and sterility (if applicable). Mechanical performance indicators such as static torsion, compression, shear, subsidence, and extrusion should be provided as research data.