1.1 本规范涵盖了用于全髋关节置换术的全髋关节假体或髋关节表面置换装置的配合支承面要求；和髋关节内假体，用于半关节置换术。更具体地说，本规范涵盖球窝配置的髋关节置换。 1.2 本规范涵盖了全髋关节假体球形关节金属或陶瓷股骨头的球形度、表面光洁度要求和尺寸公差。 1.3 本规范涵盖了金属和陶瓷髋臼组件球面凹配合面的球形度和表面光洁度要求，以及聚合物髋臼组件球面凹配合面的表面光洁度要求和尺寸公差。 1.4 本规范涵盖了髋关节内假体球形金属或陶瓷股骨头的球形度、表面光洁度要求和尺寸公差。 1.5 本规范涵盖了双极hip组件内部聚合物支承面的表面光洁度要求和尺寸公差，以及双极hip组件内部金属或陶瓷支承面的球形度和表面光洁度要求；以及髋关节内假体双极髋关节组件的外金属或陶瓷轴承表面的球形度、表面光洁度要求和尺寸公差。 1.6 本规范旨在用于全髋关节支承面的设计标准实践。此外，由于温度原因，施加在轴承表面聚合物部分上的公差有意较大- 引起的尺寸变化和其他制造问题。一些制造方法或设计可能有意减小聚合物轴承的直径，以更紧密地配合头部的直径。 1.7 以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。 1.8 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

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.