T/CSBM 0003-2021 Active

Main Technical Content: Requirements: Materials: The metal acetabular cup outer shell made of TC4 or TC4 ELI powder, whose raw material powder's physical properties and chemical composition shall comply with the relevant requirements in YY/T 1701. The mechanical properties of the material should take into account the differences in different printing directions and different positions of the molding chamber. Surface Quality: Appearance: The solid metal surface shall be free from oxide skin, knife marks, small notches, scratches, cracks, depressions, sharp edges, etc. There shall also be no embedded objects, final processing precipitates, and other contaminants. The surface of the porous part shall be free from oxide skin, embedded objects, final processing precipitates, and other contaminants. The porous layer shall not have broken threads (except for the ends). Surface Defects: The inner surface of the titanium alloy acetabular cup outer shell shall not have discontinuity defects. Surface Roughness: The roughness of the prosthesis-bone interface and the prosthesis-prosthesis mating surface of the titanium alloy acetabular cup outer shell shall be separately specified. Internal Quality: The internal defects of the titanium alloy acetabular cup outer shell shall be characterized and controlled. There shall be no defects such as un-fusion and poor fusion between printing layers in the solid metal, and cracks, pores, and holes shall be strictly controlled to ensure that its mechanical properties meet the requirements of clinical application. There shall be no broken threads in the porous layer. Microstructure: The detection sites and printing directions of the additive-manufactured titanium alloy acetabular cup shall be clarified, and the corresponding microstructural characteristics shall be specified. If heat treatment is performed, the heat treatment process shall also be specified. Dimensions and Tolerances: It shall comply with the provisions of YY/T 0809.1—2010 C