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金属陶瓷和聚合材料制全髋关节假体和髋部内用假体轴承表面的标准规格

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

摘要This specification covers the design and dimensional requirements for metallic, ceramic, and polymeric mating bearing surfaces used in total hip joint prostheses and hip endoprostheses, more specifically, hip joint replacements of the ball-and-socket configuration. This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the following: spherical articulating metallic or ceramic femoral heads of total hip joint prostheses; spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads; spherical concave mating surface of polymeric acetabular components; and spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads. This specification, however, does not address the tolerance match between the mating bearing surfaces.

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