【国外标准】 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

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.1.1 This specification covers the requirements for the mating bearing surfaces of total hip joint prostheses or resurfacing hip devices, intended for total hip arthroplasty; and hip endoprostheses, intended for hemiarthroplasty. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.1.3 This specification covers the sphericity, and surface finish requirements for the spherical concave mating surface of metallic and ceramic acetabular components, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.1.4 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical metallic or ceramic femoral heads of hip endoprostheses.1.5 This specification covers the surface finish requirements and dimensional tolerances for the inner polymeric bearing surface of bipolar hip components, and the sphericity and surface finish requirements of the inner metallic or ceramic bearing surface of bipolar hip components; and the sphericity, surface finish requirements, and dimensional tolerances of outer metallic or ceramic bearing surfaces of bipolar hip components of hip endoprostheses.1.6 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced size changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.1.7 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.