1.1 该测试方法可用于比较全膝关节置换术（TKR）的约束特征，目的是将新设计与现有临床成功设计进行比较，或确定两个类似或不同设计之间的约束差异。 1.2 本试验方法涵盖了根据固有关节设计描绘的运动量化TKR约束的方法，该设计在特定载荷条件下确定 体外试验 环境 1.3 适用于约束确定的测试为antero测试- 后牵引、中外侧剪切、旋转松弛、外翻内翻旋转和牵张（如适用）。还包括识别可能影响该运动的接触面几何参数以及报告测试结果的方法。（见实践） E4类 .) 1.4 本试验方法不是磨损试验。 1.5 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。 1.6 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。 1.7 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====== 4.1 当应用于可用产品和拟议原型时，该测试方法旨在提供一个产品功能数据库（根据建议的测试方案），以帮助医生做出更明智的全膝关节置换（TKR）选择。 4.2 合理的植入物测试方案更有可能提供TKR功能恢复能力与受体（患者）需求的适当匹配，以揭示与选择过程相关的某些设备特征。 4.3 TKR产品设计多种多样，提供了广泛的约束（稳定性）。TKR在 体外 这种情况取决于植入物部件之间的几种几何和运动学相互作用，这些相互作用可以识别和量化。TKR的运动相互作用程度应符合医生在临床检查期间确定的接受者的需求。 4.4 对于活动支撑膝关节系统，应确定整个植入结构的约束。移动轴承的约束取决于下部和上部铰接界面的设计特征。 4.5 讨论了约束/松弛测试的方法、实用性和局限性。 3. 4. 作者认识到，评估孤立植入物（即没有软组织）并不能直接预测 体内 但将允许在设计之间进行比较。约束测试也有助于表征植入物在可能遇到的极端运动范围内的性能 体内 根据患者的解剖结构、术前能力、术后活动和生活方式，频率不同。

1.1 This test method may be used to compare the constraint characteristics of total knee replacements (TKRs) with the intent of comparing new designs to existing clinically successful designs or to determine the constraint differences between two similar or dissimilar designs. 1.2 This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the inherent articular design as determined under specific loading conditions in an in-vitro environment. 1.3 Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting surfaces which would influence this motion and the means of reporting the test results. (See Practices E4 .) 1.4 This test method is not a wear test. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 This test method, when applied to available products and proposed prototypes, is meant to provide a database of product functionality capabilities (in light of the suggested test regimens) that is hoped will aid the physician in making a more informed total knee replacement (TKR) selection. 4.2 A proper matching of TKR functional restorative capabilities and the recipient's (patient’s) needs is more likely to be provided by a rational testing protocol of the implant in an effort to reveal certain device characteristics pertinent to the selection process. 4.3 The TKR product designs are varied and offer a wide range of constraint (stability). The constraint of the TKR in the in vitro condition depends on several geometrical and kinematic interactions among the implant's components which can be identified and quantified. The degree of TKR's kinematic interactions should correspond to the recipient's needs as determined by the physician during clinical examination. 4.4 For mobile bearing knee systems, the constraint of the entire implant construct shall be characterized. Constraint of mobile bearings is dictated by design features at both the inferior and superior articulating interfaces. 4.5 The methodology, utility, and limitations of constraint/laxity testing are discussed. 3, 4 The authors recognize that evaluating isolated implants (that is, without soft tissues) does not directly predict in vivo behavior, but will allow comparisons among designs. Constraint testing is also useful for characterizing implant performance at extreme ranges of motion which may be encountered in vivo at varying frequencies, depending on the patient’s anatomy, pre-operative capability, and post-operative activities and lifestyle.