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Description of ASTM-F2033 2020ASTM F2033-20Active Standard: Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric MaterialsASTM F2033Scope 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. Keywords acetabular cup; arthroplasty; femoral head; sphericity; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F2033-20 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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