T/CSBM 0001-2021 Active Group standards

T/CSBM 0001-2021 Spine Implantable 3D Printed Titanium Alloy Intervertebral Fusion Device

Publish Date: 2021-04-26 Implement Date: 2021-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBM 0001-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-04-26

Implement Date: 2021-10-01

Pages: 9 pages

Scope

Main technical content: Chemical composition: The chemical composition shall comply with the provisions of GB/T 13810. Microstructural examination: The relationship between the inspection sites and printing direction of the additive-manufactured intervertebral fusion devices shall be clarified, and the corresponding microstructural characteristics shall be specified. If heat treatment is applied, the heat treatment process and pore size shall be defined. Wire diameter: The wire diameter of the porous structure shall be specified. Porosity: The porosity of the porous structure shall be specified. Appearance of the porous part: The surface of the porous part shall be free from oxidation discoloration, embedded materials, post-processing deposits, and other contaminants. The porous layer shall not have broken wires (except at the ends). Appearance of the solid part: The machined surface of the solid part shall be free from oxidation, tool marks, small notches, scratches, cracks, indentations, sharp edges, and burrs. It shall also be free from embedded materials, post-processing deposits, and other contaminants. Dimensions: The dimensions shall be determined based on the intended implantation location and shall include at least length (L), width (W), and height (H). Mechanical properties: - Static and dynamic torsion: The static and dynamic torsion performance of the cervical intervertebral fusion devices shall be evaluated, taking into account the requirements of clinical applications. - Static axial compression and shear: The static axial compression and shear strength of cervical and thoracolumbar intervertebral fusion devices shall be evaluated, taking into account the requirements of clinical applications. - Dynamic axial compression and shear: The dynamic axial compression and shear strength of cervical and thoracolumbar intervertebral fusion devices shall be evaluated, taking into account the requirements of clinical applications. - Settli