T/CAMDI 037-2020 3D Printing of Tantalum Metal Clinical Application Standards

Scope

Main technical content: Tantalum metal is widely used in the medical field due to its excellent corrosion resistance and biocompatibility, as well as the unique advantages of porous tantalum metal such as bone ingrowth. Customized porous tantalum metal (porous) is a unique porous structural material with a structure similar to that of human bone, and its strength and toughness are better than those of human bone. 3D printed porous tantalum metal (porous) is mainly used for the repair of patients' bone defects. However, since customized 3D printed porous tantalum metal (porous) is manufactured by additive manufacturing after interactive design between attending physicians and engineers, it is difficult to ensure its safety and effectiveness with conventional testing methods and evaluation methods. Therefore, it is necessary to establish clinical application standards for 3D printed porous tantalum metal (porous) prostheses, the establishment of which is of great significance for ensuring the safety and effectiveness of clinical applications of customized 3D printed porous tantalum metal (porous). This standard provides standardized regulations for clinicians and enterprises involved in the design, production, and manufacturing of customized 3D printed porous tantalum metal (porous). It stipulates the quality management and normative requirements for the clinical application process of customized 3D printed porous tantalum metal (porous). This standard applies to orthopedic, oral, and craniomaxillofacial surgery, and is suitable for clinical applications of customized 3D printed porous tantalum metal (porous) in situations such as replacement, repair, or reconstruction of joints, spines, limbs, oral cavities, craniomaxillofacial regions, and adjacent bone tissues.

Development Information

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