1. Scope

1.1 This specification covers the requirements for the mating bearing surfaces of total hip prostheses and hip endoprostheses. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration. This specification does not address the tolerance match between the mating bearing surfaces.

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, surface finish requirements, and dimensional tolerances for the spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads, 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 and surface finish requirements for the spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads.

1.5 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.

1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ISO Documents

ANSI/ASME Document

Keywords

acetabular cup; arthroplasty; femoral head; roundness; Acetabular cups; Arthroplasty; Ceramic surgical materials/applications--specifications; Femoral surgical components--specifications; Hip replacement prosthesis--specifications; Mating bearing surfaces (of prostheses); Metallic surgical implant materials--specifications; Modular prostheses; Plastic surgical devices/applications--specifications; Polymers (surgical applications)--specifications; Roundness

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2033-05

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