1.1 本规程描述了通过微动腐蚀测量评估承受循环载荷的模块化髋关节植入物头部和阀杆连接处的孔和锥体界面的机械稳定性的测试、分析和表征方法 ( 1- 5. ) . 2. 描述的两种试验方法如下: 1.1.1 方法I- 该方法的主要目的是为长期试验提供一套统一的指南，以通过测量微动和微动腐蚀产生的腐蚀产物和微粒碎片来确定损坏量。 损伤也可通过表征孔和锥体表面的损伤来评估 ( 4. , 5. ) . 1.1.2 方法II- 该方法可用于模块化界面微动腐蚀的短期电化学评估。该方法的目的不是产生损伤或颗粒碎片，而是提供一种快速方法，用于定性评估不包括材料变化的设计变化 ( 1- 4. ) . 1.2 本规程不提供对以下情况的判断或预测 体内 植入物性能，而是提供了一套统一的指南，用于评估不同植入物设计、构造或材料之间性能的相对差异，其性能是根据微动和微动腐蚀量定义的。此外，这种做法应允许直接比较独立研究小组之间的微动腐蚀数据，从而建立模块化植入物性能的数据库。 1.3 本规程规定了对制造的髋股骨头和股骨柄以及试样进行对比试验- 模块连接的公锥部分不包括整个髋关节植入物，试样的锥部分在设计、制造和材料上与最终髋关节植入体的锥部相同的型式试样试验 ( 4. , 5. ) . 1.4 本实施规程的方法I允许同时评估股骨干的疲劳强度（根据实施规程 1440层 )以及模块化接口的机械稳定性和微动和微动腐蚀产生的碎屑。 1.5 本实践中描述的一般概念和方法可应用于全关节假体中其他模块化接口的研究。 1.6 以国际单位表示的数值视为标准值。本标准不包括其他计量单位。 1.7 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。 1.8 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 全关节假体的模块化接口受到微动的影响，可能导致微动和腐蚀。腐蚀产物和微粒碎片的释放可能会刺激不良的生物反应，并导致铰接界面的加速磨损。 因此，评估模块化接口稳定性和耐腐蚀性的方法是设备测试的重要组成部分。 5.2 长期的 体外 测试对于模块化接口的微动产生损伤和碎片至关重要 ( 4. , 5. ) 建议使用蛋白质溶液，以最好地模拟 体内 环境 5.3 短期测试通常有助于评估设备开发期间的设计差异 ( 1- 4. ) 电化学方法提供了微动腐蚀速率的半定量测量。 然而，机械和电化学过程对总腐蚀和微粒释放现象的相对贡献尚未确定；因此，这些试验不应用于比较材料组合变化的影响，而应用于评估孔（头）和锥（杆）组件的设计变化。 5.4 建议使用这些试验评估髋股骨头和股骨柄组件模块接口的微动磨损和腐蚀。类似的方法也可应用于其他模块化接口，其中存在微动腐蚀问题。 5.5 建议使用这些方法对髋-股骨头和颈部模块化接口考虑的新材料、涂层或设计或其组合的微动磨损和腐蚀进行比较评估。用于测试的部件可以是制造的模块化髋关节装置（成品）或试样，其设计和制造用于模拟模块化髋髋关节装置的头部、锥度和颈部区域。

1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion ( 1- 5 ) . 2 Two test methods described are as follows: 1.1.1 Method I— The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage is also assessed by characterization of the damage to the bore and cone surfaces ( 4 , 5 ) . 1.1.2 Method II— This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes ( 1- 4 ) . 1.2 This practice does not provide for judgment or prediction of in-vivo implant performance, but rather provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus provide for building of a data base on modular implant performance. 1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon-type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant ( 4 , 5 ) . 1.4 Method I of this practice permits simultaneous evaluation of the fatigue strength of a femoral hip stem (in accordance with Practice F1440 ) and the mechanical stability and debris generated by fretting and fretting corrosion of the modular interface. 1.5 The general concepts and methodologies described in this practice could be applied to the study of other modular interfaces in total joint prostheses. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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 The modular interfaces of total joint prostheses are subjected to micromotion that could result in fretting and corrosion. The release of corrosion products and particulate debris could stimulate adverse biological reactions, as well as lead to accelerated wear at the articulation interface. Methods to assess the stability and corrosion resistance of the modular interfaces, therefore, are an essential component of device testing. 5.2 Long-term in-vitro testing is essential to produce damage and debris from fretting of a modular interface ( 4 , 5 ) . The use of proteinaceous solutions is recommended to best simulate the in-vivo environment. 5.3 Short-term tests often can be useful in evaluations of differences in design during device development ( 1- 4 ) . The electrochemical methods provide semiquantitative measures of fretting corrosion rates. The relative contributions of mechanical and electrochemical processes to the total corrosion and particulate release phenomena, however, have not been established; therefore, these tests should not be utilized to compare the effects of changes in material combinations, but rather be utilized to evaluate design changes of bore (head) and cone (stem) components. 5.4 These tests are recommended for evaluating the fretting wear and corrosion of modular interfaces of hip femoral head and stem components. Similar methods may be applied to other modular interfaces where fretting corrosion is of concern. 5.5 These methods are recommended for comparative evaluation of the fretting wear and corrosion of new materials, coatings, or designs, or a combination thereof, under consideration for hip femoral head and neck modular interfaces. Components for testing may be those of a manufactured modular hip device (finished product) or sample coupons, which are designed and manufactured for simulation of the head, taper, and neck region of a modular hip device.