1.1 本试验方法提供了一种筛选试验，用于确定由于螺钉头和板孔埋头孔区域之间的接触区域内的微动腐蚀而导致的用于接骨（骨折内固定）的钢板和螺钉的金属损失量。植入物以临床使用的形式使用。所述机器在钢板和螺钉之间产生相对运动，模拟临床使用这些设备时可能出现的一种运动模式。 1.2 由于本试验方法中使用的环境和应力条件可能与人体内骨板所经历的环境和应力条件不同，因此本试验方法可能会产生低于或高于实践中所经历的微动腐蚀速率。 推荐的400 N轴向载荷的选择范围是微动腐蚀量对轴向载荷的微小变化不敏感 ( 1. ) . 2. 推荐载荷和角位移的组合使得外科合金在相对较短的时间内（7到14天）发生可测量的微动腐蚀。 （参考文献 1- 3. ) 1.3 该装置的设计有助于对试样和试验室进行灭菌，以允许使用在非无菌条件下会被微生物生长污染的蛋白质溶液进行试验。 1.4 使用的样本可以是标准的骨固定植入物，也可以是制造成适当形状的材料。 1.5 本试验方法可用于测试类似或不同合金成分的金属板和螺钉的微动腐蚀，也可用于测试金属-非金属组合的微动腐蚀。该试验方法也可用于非金属材料的磨损或降解研究。本试验方法可用作筛选试验，以对盐水或蛋白质溶液的腐蚀性进行排名，或对金属对金属的抗微动腐蚀性进行排名，或研究其他材料组合。 1.6 以国际单位制或英寸-磅单位表示的数值应单独视为标准值。每个系统中规定的值不一定是精确的等价物； 因此，为确保符合本标准，每个系统应独立使用，且两个系统的值不得组合。 1.7 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。 1.8 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====== 4.1 通过使用后对植入物的检查可知，用于骨固定的钢板和螺钉由于钢板-螺钉界面的腐蚀而遭受金属损失。这种腐蚀的机理之一是由于螺钉头和板孔埋头孔之间的相对运动（微动）引起的微动腐蚀。 4.2 众所周知，腐蚀产物释放到植入物周围的组织中可能会对局部组织产生不利影响或产生全身影响。因此，将组织暴露于腐蚀产物的量降至最低是很重要的。 4.3 根据规范，螺钉和板有不同的配置 F543页 和 F382型 . 本试验方法可用于评估螺钉和板设计的不同组合的效果。随着用于治疗骨折的新材料和设备设计的开发，确定这些开发对微动腐蚀引起的金属损失量的影响非常重要。 4.4 本试验方法提供了一种标准化筛选试验，用于根据金属板和螺钉的抗微动腐蚀性对其进行排序，并确定不同溶液对微动腐蚀速率的影响。 4.5 本试验方法也可用于生成腐蚀产物，用于产品的化学分析，或用于使用动物或细胞培养方法测试对腐蚀产物的生物反应。 4.6 众所周知，微动腐蚀速率取决于正常载荷或压力、频率、滑动幅度、材料、表面处理和环境因素。 ( 4. ) 因此，在确定更改其中一个参数（例如，材料或环境）的影响时，所有其他参数必须保持不变，以便于解释结果。

1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants are used in the form they would be used clinically. The machine described generates a relative motion between plates and screws which simulates one type of motion pattern that can occur when these devices are used clinically. 1.2 Since the environmental and stress conditions used in this test method may not be identical to those experienced by bone plates in the human body, this test method may produce fretting corrosion rates that are lower or higher than those experienced in practice. The recommended axial load of 400 N was selected as being in a range where the amount of fretting corrosion is not sensitive to small changes in axial load ( 1 ) . 2 The combination of the recommended load and angular displacement are such that a measurable amount of fretting corrosion of surgical alloys occurs in a comparatively short period of time (7 to 14 days). (Refs 1- 3 ) 1.3 The device is designed so as to facilitate sterilization of the test specimens and test chambers to permit testing with proteinaceous solutions that would become contaminated with microbial growth in nonsterile conditions. 1.4 The specimens used can be standard osteosynthesis implants or can be materials fabricated into the appropriate shapes. 1.5 This test method may be used for testing the fretting corrosion of metal plates and screws of similar or different alloy compositions, or it may be used for testing the fretting corrosion of metal-nonmetal combinations. This test method may also be used for wear or degradation studies of nonmetallic materials. This test method may be used as a screening test to rank the corrosivities of saline or proteinaceous solutions, or to rank metal-to-metal couples for resistance to fretting corrosion, or to study other material combinations. 1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 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 ====== 4.1 It is well known from examination of implants after use that plates and screws used for osteosynthesis are subjected to metal loss due to corrosion at the plate-screw interfaces. One of the mechanisms of this corrosive attack is fretting corrosion due to relative motion (micromotion) between the screw heads and plate-hole countersinks. 4.2 It is also known that release of corrosion products into the tissues surrounding an implant may have adverse effects on local tissue or have systemic effects. Thus, it is important to minimize the amount of tissue exposure to corrosion products. 4.3 Screws and plates are available in different configurations in accordance with Specifications F543 and F382 . This test method may be used to evaluate the effects of different combinations of screw and plate designs. As new materials and device designs are developed for use in the treatment of fractured bones, it is important to determine the effects these developments have on the amount of metal loss due to fretting corrosion. 4.4 This test method provides a standardized screening test for ranking metal plates and screws in terms of resistance to fretting corrosion and for determining the influence of different solutions on fretting corrosion rates. 4.5 This test method may also be used to generate corrosion products either for chemical analysis of the products or for testing for biological reactions to corrosion products using animal or cell culture methods. 4.6 It is well known that fretting corrosion rates depend on normal load or pressure, frequency, sliding amplitude, materials, surface treatments, and environmental factors. ( 4 ) Therefore, when determining the effect of changing one of these parameters (for example, material or environment), all others must be kept constant to facilitate interpretation of the results.