T/CSBM 0002-2021 Active

Main technical content: Requirements: Chemical composition: The chemical composition of additive manufactured artificial vertebrae shall comply with the provisions of GB/T 13810. Microstructure: The relationship between the detection sites of additive manufactured artificial vertebrae and the printing direction and the corresponding microstructural characteristics shall be clearly defined. If heat treatment is performed, the heat treatment process shall be specified. Appearance of porous parts: The surface of the porous parts shall be free from oxidation discoloration, and shall also be free from embedded materials, post-processing deposits, and other contaminants. The porous layer shall not have broken threads (except at the ends). Solid parts: The machined surface of the solid parts shall be free from oxidation scale, knife marks, small notches, scratches, cracks, indentations, sharp edges, and burrs, and shall also be free from embedded materials, post-processing deposits, and other contaminants. Pore size: The pore size of the porous structure of the artificial vertebrae shall be specified. Wire diameter: The wire diameter of the porous structure of the artificial vertebrae shall be specified. Porosity: The porosity of the porous structure of the artificial vertebrae shall be specified. Dimensions: The dimensions shall be determined according to the intended implantation location (if applicable), and shall at least include the vertebral body height (H), the anterior-posterior diameter of the cross-section (L), the left-right diameter of the cross-section (W), and the angle between the upper and lower end faces (a). Static and dynamic torsion of cervical artificial vertebrae: The static and dynamic torsion performance of cervical artificial vertebrae shall be evaluated, taking into account the requirements of clinical application. Static axial compression and shear: The static axial compression and shear performance of cervical and thoracolumbar artificial verteb