1.1 本指南介绍了各种形式的nucleus置换和nucleus增强装置。它进一步概述了在评估这些设备的性能时推荐的测试类型。 1.2 本指南未涉及核置换装置中所用材料的生物相容性。但是，用户应单独调查其设备的生物相容性（参见 X1.1 ). 1.3 虽然据了解，脱出和终板骨折代表有记录的临床失败，但本指南并没有具体解决这些问题，尽管已经包括了一些与脱出相关的因素（参见 X1.3 ). 1.4 本指南中描述了多项测试；然而，用户不需要全部使用它们。本指南的用户有责任确定哪些测试适合被测试的设备及其潜在应用。 有些测试可能不适用于所有类型的设备。此外，一些nucleus设备可能在所有测试配置中都不稳定。然而，这并不一定意味着所述试验方法不适用。 1.5 nucleus器件设计科学还很年轻，包括的技术变化比本指南修改的速度更快。因此，用户必须仔细考虑本指南对用户特定设备的适用性；该指南可能并不适用于所有设备。例如，在出版时，本指南未涉及设计为在体内部分或完全可吸收的细胞核置换和细胞核增强装置。然而，本指南中建议的一些测试可能适用于评估此类设备。 尚未证明nucleus装置的机械故障与不良临床结果有关。因此，在评估拟议的nucleus设备时，应谨慎使用本标准。 1.6 本指南并非性能标准。本指南的用户有责任描述正在评估的nucleus设备的安全性和有效性。 1.7 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。角度测量可以以度或弧度报告。 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。 ====意义和用途====== 5.1 核装置通常设计用于增强天然变性核材料的机械功能，或替换在手术过程中切除的组织。本指南概述了评估多种不同类型设备的方法。设备之间的比较必须谨慎仔细地进行分析，考虑到设计和功能差异可能对测试配置和整体性能产生的影响，以及机械故障可能与临床故障无关，反之，机械成功可能与临床成功无关的可能性。 5.2 进行这些测试 体外 允许在特定测试模式下分析nucleus装置的机械性能。施加的荷载可能不同于所看到的复杂荷载 体内 因此，这些测试的结果可能无法直接预测 体内 表演 5.3 这些测试用于量化不同植入设计的静态和动态特性和性能。进行机械试验 体外 使用简化荷载和力矩。在模拟体液或生理盐水中进行疲劳试验可能会对装置产生微动、老化、腐蚀或润滑影响，从而影响被测装置的相对性能。因此，测试环境和该环境的影响，无论是模拟体液、生理盐水浴（9 g NaCl/1000 mL H 2. O） 或干燥是测试的一个重要特征，必须准确报告。 5.4 动态测试方法的设计应能回答以下问题，包括但不限于:设备在循环后是否仍能按预期工作？它是否保留了足够的性能特征（例如，机械和运动学特性，如ROM）？设备是否磨损或退化？如果有证据表明设备磨损或退化，应使用通常可用的合理方法对其进行识别和量化。如果技术可行，用户应区分装置产生的颗粒物和试验模型和夹具产生的颗粒物。

1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices. 1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their device separately (see X1.1 ). 1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3 ). 1.4 Multiple tests are described in this guide; however, the user need not use them all. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential application. Some tests may not be applicable for all types of devices. Moreover, some nucleus devices may not be stable in all test configurations. However, this does not necessarily mean that the test methods described are unsuitable. 1.5 The science of nucleus device design is still very young and includes technology that is changing more quickly than this guide can be modified. Therefore, the user must carefully consider the applicability of this guide to the user’s particular device; the guide may not be appropriate for every device. For example, at the time of publication, this guide does not address the nucleus replacement and nucleus augmentation devices that are designed to be partially or completely resorbable in the body. However, some of the test recommended in this guide may be applicable to evaluate such devices. It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore this standard should be used with care in evaluating proposed nucleus devices. 1.6 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the nucleus device under evaluation. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. Angular measurements may be reported in either degrees or radians. 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 ====== 5.1 Nucleus devices are generally designed to augment the mechanical function of native degenerated nucleus material or to replace tissue that has been removed during a surgical procedure. This guide outlines methods for evaluating many different types of devices. Comparisons between devices must be made cautiously and with careful analysis, taking into account the effects that design and functional differences can have on the testing configurations and overall performance, and the possibility that mechanical failure may not be related to clinical failure and inversely, that mechanical success may not be related to clinical success. 5.2 These tests are conducted in vitro to allow for analysis of the mechanical performance of the nucleus device under specific testing modalities. The loads applied may differ from the complex loading seen in vivo , and therefore the results from these tests may not directly predict in vivo performance. 5.3 These tests are used to quantify the static and dynamic properties and performance of different implant designs. The mechanical tests are conducted in vitro using simplified loads and moments. Fatigue testing in a simulated body fluid or saline may have fretting, aging, corroding, or lubricating effects on the device and thereby affect the relative performance of tested devices. Hence, the test environment and the effect of that environment, whether a simulated body fluid, normal saline bath (9 g NaCl per 1000 mL H 2 O), or dry, is an important characteristic of the test and must be reported accurately. 5.4 Dynamic testing methods should be designed to answer the following questions, including but not limited to: Does the device still function as intended after cycling? Does it retain adequate performance characteristics (for example, mechanical and kinematic properties such as ROM)? Did the device wear or degrade? If there is evidence of wear or degradation of the device, it should be identified and quantified with reasonable methods generally available. The user shall distinguish between particulates generated by the device and particulates generated by the test model and fixtures if technically feasible.