1.1 本试验方法使用循环（正向和反向）动电位极化评估小型金属植入医疗器械或其部件的腐蚀敏感性。可通过该测试方法评估的装置类型的示例包括但不限于血管支架、输尿管支架（规范 F1828 )、过滤器、血管内移植物的支撑段、心脏封堵器、动脉瘤或结扎夹、吻合钉等。 1.2 该测试方法用于评估设备的最终形态和完成情况，因为它将被植入。这些小型设备应进行全面测试。装置尺寸的上限由试验装置的电流输送能力决定（见第 6. ). 假设参考测试方法等测试方法 G5 和试验方法 G61 已被用于材料筛选。 1.3 由于植入物的配置和尺寸多种多样，该测试方法提供了多种试样架配置。 1.4 本试验方法适用于由耐腐蚀性相对较高的金属制成的植入式设备。 1.5 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.6 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。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。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 5.1 植入式医疗器械的腐蚀会对器械性能产生有害影响，或可能导致腐蚀产物的释放，从而产生有害的生物后果；因此，确定设备的一般腐蚀行为以及对局部腐蚀的敏感性非常重要。 5.2 用于制造可植入装置的成型和精加工步骤可能会对制造装置的材料的耐腐蚀性产生重大影响。在选择用作植入式装置的材料的过程中，测试材料的耐腐蚀性是一个重要步骤；然而，它不一定提供关于设备性能的关键数据。 5.3 为了适应各种各样的设备形状和尺寸，可以使用各种固定设备。 5.4 请注意，该方法是有意设计的，以达到足以导致医疗器械故障和劣化的严重条件，并且不一定会遇到这些条件 体内 在人工生理电解质中进行的腐蚀测试的结果可以为不同器件材料、设计或制造工艺的比较提供有用的数据。但是，请注意，该测试方法没有考虑细胞、蛋白质等对腐蚀行为的影响 体内 .

1.1 This test method assesses the corrosion susceptibility of small metallic implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828 ), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth. 1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6 ). It is assumed that test methods such as Reference Test Method G5 and Test Method G61 have been used for material screening. 1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations. 1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion. 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 ====== 5.1 Corrosion of implantable medical devices can have deleterious effects on the device performance or may result in the release of corrosion products with harmful biological consequences; therefore it is important to determine the general corrosion behavior as well as the susceptibility of the devices to localized corrosion. 5.2 The forming and finishing steps used to create an implantable device may have significant effects on the corrosion resistance of the material out of which the device is fabricated. During the selection process of a material for use as an implantable device, testing the corrosion resistance of the material is an essential step; however, it does not necessarily provide critical data regarding device performance. 5.3 To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used. 5.4 Note that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown and deterioration of the medical devices and that these conditions may not necessarily be encountered in vivo . The results of this corrosion test conducted in artificial physiological electrolytes can provide useful data for comparison of different device materials, designs, or manufacturing processes. However, note that this test method does not take into account the effects of cells, proteins, and so forth, on the corrosion behavior in vivo .