1.1 运动路径、负荷历史和负荷模式都会导致植入假体的磨损、退化和损伤。模拟各种功能活动有望为磨损和损伤模式评估提供更真实的测试。这种活动通常被称为日常生活活动（ADL）。文献中确定的ADL包括行走、楼梯上升和下降、坐到站、站到坐、蹲下、跪下、盘腿坐、入浴、出浴、转身和切割动作 ( 1个- 7. ) 。 2. 行走步态以外的活动通常涉及更大的运动范围和更高的负载条件，这可能会导致正常磨损以外的损坏和故障模式 ( 8个- 10 ) 。 1.2 本文件为可用于评估的功能模拟提供了指导 体外 受力控制的膝关节假体装置的耐用性。 1.3 功能模拟被定义为再现日常生活活动中可能遇到的负载和运动，但它不一定涵盖所有可能的负载类型。 功能模拟不同于典型的磨损测试，因为它试图在可能遇到的各种负载和运动条件下锻炼假肢装置 就地 以揭示在假体装置的整个寿命中可能遇到的各种损伤模式和损伤机制。 1.4 力控制被定义为试验机的控制模式，其接受力水平作为设定点输入，并利用控制回路中的力反馈信号来实现该设定点输入。 对于膝关节模拟，屈曲运动置于角位移控制下，内部和外部旋转置于扭矩控制下，轴向载荷、前后剪切和内侧-外侧剪切置于力控制下。 1.5 本文件规定了日常生活活动的动力学和运动学测试条件，包括步行、转弯导航、爬楼梯、下楼梯和深蹲。动力学和运动学测试条件表示为用于驱动相关模拟器机器致动器的参考波形。 这些波形表示运动，如在屈曲-伸展的情况下，或表示由身体动力学、重力和作用在膝盖上的活跃肌肉组织产生的力和力矩的动力学信号。 1.6 本文件未涉及假体装置的损伤模式、磨损或故障的评估或测量。 1.7 这份文件是一份指南。正如ASTM在其“ASTM标准的形式和风格”一书中第C15.2节中所定义的那样，“标准指南是不推荐具体行动方案的信息或一系列选项的简编。 指南旨在提高对特定主题领域的信息和方法的认识。指南可能会提出一系列选项或指示，提供指导，而不建议明确的行动方案。这类标准的目的是在观点一致的基础上提供指导，而不是建立在所有情况下都要遵循的标准做法。”本指南旨在提供负载概况和测试程序，以开发可能用于全膝关节置换术磨损、耐久性或其他类型测试的测试。 如本定义所述，指南提供了测试指南，但不要求进行具体测试。因此，例如，如果用户不能控制载荷分布中给出的一种力控制模式，则该用户不需要执行该加载模式。 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）。本标准的使用者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。 ====意义和用途====== 4.1 本测试指南的目的是提供关于如何测试全膝关节置换术的负荷概况信息，以评估 体外 如中所述，它在几种类型的膝盖运动中的功能和磨损 4.2 和 4.3 。 4.2 当植入物根据指定的载荷和位移波形重复移动时，该测试指南可能有助于表征植入物磨损的幅度和位置。 4.3 该测试指南还可以帮助描述全膝关节置换术的功能限制，因为其运动是由这些波形引导的。这些限制可以被观察为软组织约束中的撞击、半脱位或高负荷，无论它们是物理地还是虚拟地表示。 4.4 运动和载荷条件 体内 一般而言，将不同于本指南中定义的载荷和运动。从本指南中获得的结果不能用于直接预测 体内 表演然而，本指南旨在允许在类似条件下进行测试时，对不同膝盖设计的性能进行比较。

1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions ( 1- 7 ) . 2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear ( 8- 10 ) . 1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control. 1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device. 1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control. 1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee. 1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device. 1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended to increase the awareness of information and approaches in a given subject area. Guides may propose a series of options or instructions that offer direction without recommending a definite course of action. The purpose of this type of standard is to offer guidance based on a consensus of viewpoints but not to establish a standard practice to follow in all cases.” The intent of this guide is to provide loading profiles and test procedures to develop testing that might be used for wear, durability, or other types of testing of total knee replacements. As noted in this definition, a guide provides guidance on testing, but does not require specific testing. Thus, for example, if a user is unable to control one mode of force control given in the load profiles, that user is not required to perform that mode of loading. 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. ====== Significance And Use ====== 4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3 . 4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms. 4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually. 4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.