1.1 本指南指定了一种测量表面特征（如丘陵和山谷）并估算 体内 锥形锥形连接处的材料损失，如股骨头/股骨干连接处或移植的模块化髋关节假体、模块化膝关节或肩关节的适配器套筒。本指南适用于任何铰接轴承材料、阀杆材料和锥形锥度尺寸。本指南中的原则可应用于其他锥形接头的设计，例如某些髋关节中的模块化股骨干/颈部接头。 1.2 本指南包括如何使用圆度仪进行测量的信息 ( 1. 4. ) 坐标测量机（CMM） ( 5. ) ，光学坐标测量机 ( 6. , 7. ) . 2. 如果设备足够可靠和准确，能够提供与上述设备相当的估计值，则可以使用其他设备来估算材料损失。 注1: 材料损失的最大深度对数据点的数量和间距很敏感。 1.3 本标准指南中描述的测量技术使用接触针和/或光学仪器在锥体表面进行的测量。锥形接头中的配合材料和几何形状在使用过程中可能会在形状、结构和成分上发生变化。这些变化将影响任何最终估计。此外，对原始表面形状的任何估计也会影响对材料损失的任何最终估计。 锥形接合处的材料损失/腐蚀机制可能导致锥形表面出现氧化层或腐蚀产物。这些层可能会导致对材料损失量的低估。 1.4 外植体在锥形连接处的表面可能有碎屑或生物沉积物。这些沉积物会妨碍锥形接头表面的测量，在决定清洁方案时必须考虑它们对测量的影响。 1.5 本标准可能涉及危险材料、操作和设备。作为预防措施，应采用不会对植入物或可能成为后续分析对象的相关组织产生不利影响的适当方法对移植的装置进行消毒或最低限度的消毒。 ISO 12891-1中详细讨论了处理人体组织时使用的预防措施。本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。

1.1 This guide specifies a method to measure the surface features, such as hills and valleys, and to estimate the in vivo material loss from the conical taper junctions, such as the femoral head/stem junction or adapter sleeve from explanted modular hip prosthesis, modular knee, or shoulder joints. This guide is applicable to any articulating bearing material, stem material, and conical taper size. The principles in this guide may be applied to other designs of taper junction, such as the modular stem/neck junction found in some hip joints. 1.2 This guide includes information on how to perform measurements using a Roundness Machine ( 1- 4 ) , Coordinate Measuring Machine (CMM) ( 5 ) , and Optical Coordinate Measuring Machine ( 6 , 7 ) . 2 Other equipment may be used to estimate material loss if the equipment is reliable and accurate enough to provide comparable estimates to the aforementioned equipment. Note 1: The maximum depth of material loss is sensitive to the number and spacing of data points. 1.3 The measurement techniques described in this standard guide use measurements taken on the surface of the taper using contact stylus and/or optical instruments. The mating materials and geometries in the taper junction can have changed in form, structure, and composition during use. These changes will impact any final estimation. In addition, any estimation of original surface form will also impact any final estimation of material loss. The material loss/corrosion mechanisms in the taper junction can lead to oxide layers or corrosion products on the surface of the taper. These layers can lead to an underestimation of the volume of material loss. 1.4 The explants can have debris or biological deposits on the surfaces of the taper junctions. These deposits can prevent the measurement of the surface of the taper junction, and their effect on the measurement must be considered when deciding the cleaning protocol. 1.5 This standard may involve hazardous materials, operations and equipment. As a precautionary measure, explanted devices should be sterilized or minimally 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. 1.6 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.