If you are an ASTM Compass Subscriber and this document is part of your subscription, you can access it for free at ASTM Compass
    ASTM F2033 - 20

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

    Active Standard ASTM F2033 | Developed by Subcommittee: F04.22

    Book of Standards Volume: 13.01


      Format Pages Price  
    PDF 6 $54.00   ADD TO CART
    Hardcopy (shipping and handling) 6 $54.00   ADD TO CART
    Standard + Redline PDF Bundle 12 $64.00   ADD TO CART



    Abstract

    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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    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.


    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

    ISO 7206-2 Implants for SurgeryPartial and Total Hip Joint ProsthesisPart II: Bearing Surfaces Made of Metallic and Plastics Materials

    ANSI/ASME Document

    ANSI/ASME B46.1 -1995 Surface Texture


    ICS Code

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

    UNSPSC Code

    UNSPSC Code 42321707(Total hip replacement kit or system)


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F2033-20

    Citation Format

    ASTM F2033-20, Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials, ASTM International, West Conshohocken, PA, 2020, www.astm.org

    Back to Top