1.1 本标准指南提供了测量轴承表面和估计 体内 外植金属对金属（MoM）和其他“硬”（例如陶瓷）髋部组件的磨损。本指南涵盖了使用尺寸变化方法测量髋臼杯和股骨头，适用于所有假体髋关节类型，包括带柄（模块化）和表面置换髋关节系统。 1.2 本指南中规定的方法不适用于测量 体内 非关节表面的磨损，例如模块化连接（在阀杆/颈部、颈部/头部或杯衬/外壳接口处）或髋臼杯边缘。 1.3 本指南中评估和报告的参数（磨损深度和体积磨损）是根据假设的组件制造形状估计的。使用数值积分方法计算磨损量，磨损深度为假设值之间的差值- 制造形状和测量表面。 1.4 本指南涵盖了使用坐标测量机（CMM）测量磨损深度和体积磨损，以及使用圆度机测量磨损深度。如果测量的分辨率和精度与本标准中详述的仪器相当，则可以使用其他计量测量设备来测量磨损深度或体积。测量和分析协议应基于本标准中描述的协议。 1.5 本指南适用于制造时标称为球形的髋关节。由于制造或变形可能导致形状偏差，并且可能需要使用非球面来表示部件的未磨损表面。考虑不对称设计的髋关节超出了本指南的范围，尽管原则和技术可能适用于关节表面磨损的表征。 1.6 本指南旨在扩展实践 F561页 作为第二阶段无损检测。 1.7 本标准可能涉及危险材料、操作和设备。作为预防措施，应采用适当的方法对植入器械进行消毒或消毒，但不得对可能成为后续分析对象的植入物或相关组织产生不利影响。ISO 12891-1中详细讨论了处理人体组织时使用的预防措施。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。 1.8 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 standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems. 1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for example modular connections (at the stem/neck, neck/head, or cup liner/shell interface) or at the acetabular cup rim. 1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth is the difference between the assumed as-manufactured shape and the measured surface. 1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine (CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard. 1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and techniques may be applicable to the characterization of wear from the articulating surfaces. 1.6 This guide is intended as an extension to Practice F561 as a Stage II nondestructive test. 1.7 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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. 1.8 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.