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Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear 剪切中解剖型骨关节锁定机构静态评估的标准试验方法
发布日期: 2023-03-01
1.1 本试验方法涵盖了一种确定解剖型全肩关节置换假体中使用的模块化解剖型关节盂组件静态剪切拆卸力的方法。 1.2 虽然所描述的方法并不复制所有生理力条件,但它是一种 体外 在规定的测试条件下,比较模块化解剖关节盂组件设计和关节插入物和关节盂衬垫之间的固位机制强度。 1.3 该测试方法包括由单独的关节插入物和衬垫组成的模块化关节盂组件。插件和衬垫可由以下材料的任意组合制成: 金属合金、聚合材料、复合材料。 1.4 以国际单位制表示的值应视为标准值。本标准不包括其他测量单位。 1.5 本标准并不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(TBT)委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 该测试方法可用于描述材料、制造和设计变量对金属或复合材料支撑的解剖关节盂假体锁定机制抗静态剪切载荷性能的影响。 4.2 关节盂组件用于肩关节置换,应符合规范中规定的标准 第1378页 . 4.3 金属或复合材料支持的解剖型关节盂假体的负载 体内 一般而言,将不同于本试验方法中定义的荷载。此处获得的结果不能用于直接预测 体内 表演 然而,当在相同的测试条件下进行测试时,该测试方法的设计允许在不同的金属或复合材料支撑的解剖关节盂锁定机构设计之间进行比较。 4.4 该测试方法可能不适用于所有类型的植入物应用。鉴于所测试的材料及其潜在应用,提醒用户考虑该方法的适当性。 4.5 为了使金属或复合材料支撑的解剖关节盂组件的测试数据具有可比性、可重复性,并能够在实验室间相互关联,必须建立统一的程序。
1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses. 1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of modular anatomic glenoid component designs and the strength of the retention mechanism between the articular insert and glenoid backing under the stated test conditions. 1.3 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. ====== Significance And Use ====== 4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of metal or composite-backed anatomic glenoid prostheses’ locking mechanisms to resist static shear loading. 4.2 The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F1378 . 4.3 The loading of metal or composite-backed anatomic glenoid prostheses in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to allow for comparisons between different metal or composite-backed anatomic glenoid locking mechanism designs, when tested under the same testing conditions. 4.4 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested and their potential application. 4.5 In order for the test data on metal or composite-backed anatomic glenoid components to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
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归口单位: F04.22
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