1.1 本试验方法包括进行电偶腐蚀试验，以表征两种不同金属在电接触中的行为，这两种金属将在人体内用作医用植入物或医用植入物的组成部分。可能评估的设备类型示例包括不同合金的重叠支架、支架和支架标记组合、矫形钢板和螺钉，其中一个或多个螺钉的合金与设备的其余部分不同，以及多部件结构，其中两个或多个合金用于各种部件。 将部分植入但在体内长期接触的装置（如外固定装置）也可以使用该方法进行评估。 1.2 本试验方法包括试样的选择、试样制备、试验环境、暴露方法和评估结果的方法，以表征电解液中电偶的行为。 1.3 设备和设备组件拟在其成品状态下进行测试，就像植入一样（即，样品的冶金和表面状态应处于或尽可能接近成品设备中的相同状态）。 1.4 本试验方法不涉及设备中可能发生的其他类型的腐蚀和降解损伤，例如微动、裂缝或任何电流感应电位对应力腐蚀和腐蚀疲劳的影响。表面改性，例如划痕（可能在植入过程中引入）或焊接影响（在制造过程中），也没有得到解决。这些机制不在本测试方法的范围内。 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 警告- 许多监管机构已将汞指定为一种危险物质，可导致严重的医疗问题。汞或其蒸汽已被证明对健康有害，并对材料具有腐蚀性。处理汞和含汞产品时要小心。有关更多信息，请参阅适用的产品安全数据表（SDS）。当地或国家法律禁止销售汞或含汞产品，或两者兼有。用户必须确定其所在地销售的合法性。 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。 注1: 本文还提供了电偶腐蚀试验的其他信息，以及电解质中电偶腐蚀试验的实施和评估示例。 2. 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====== 3.1 植入式医疗器械可以由不同的金属制成，或者与不同的金属发生电接触，从而导致潜在的电偶腐蚀，这可能导致释放具有有害生物后果的腐蚀产物，或者损害器械的结构完整性。因此，确定这些类型设备对电偶腐蚀的敏感性很重要。 3.2 使用本试验方法旨在提供关于两种彼此接触的不同金属的可能腐蚀电偶成分的信息。 接触的不同金属可能位于同一可植入医疗设备上，或作为单个医疗植入设备的组成部分。 3.3 本试验方法的设计可适应各种夹持装置的使用所遇到的各种装置形状和尺寸。 3.4 本标准是在模拟生理环境中进行电偶腐蚀试验的试验方法。遵守此测试方法应有助于避免此类测试中的一些固有困难。其他标准，如指南 G71 虽然它们提供了有价值的背景信息，但并不提供测试医疗器械植入物的必要细节或特异性。

1.1 This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed include overlapping stents of different alloys, stent and stent marker combinations, orthopedic plates and screws where one or more of the screws are of a different alloy than the rest of the device, and multi-part constructs where two or more alloys are used for the various component parts. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method. 1.2 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in an electrolyte. 1.3 Devices and device components are intended to be tested in their finished condition, as would be implanted (that is, the metallurgical and surface condition of the sample should be in or as close as possible to the same condition as in the finished device). 1.4 This test method does not address other types of corrosion and degradation damage that may occur in a device such as fretting, crevices, or the effect of any galvanically induced potentials on stress corrosion and corrosion fatigue. Surface modifications, such as from scratches (possibly introduced during implantation) or effects of welding (during manufacture), are also not addressed. These mechanisms are outside of the scope of this test method. 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 Warning— Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 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. Note 1: Additional information on galvanic corrosion testing and examples of the conduct and evaluation of galvanic corrosion tests in electrolytes are given. 2 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 ====== 3.1 Implantable medical devices can be made of dissimilar metals or come into electrical contact with dissimilar metals leading to the potential for galvanic corrosion, which may result in the release of corrosion products with harmful biological consequences or a compromise of structural integrity of the device. Therefore, it is important to determine the susceptibility of these types of devices to galvanic corrosion. 3.2 Use of this test method is intended to provide information on the possible galvanic component of corrosion of two dissimilar metals in contact with one another. The dissimilar metals in contact may be on the same implantable medical device or as component parts of individual medical implant devices. 3.3 This test method has been designed to accommodate a wide variety of device shapes and sizes encountered by allowing the use of a variety of holding devices. 3.4 This standard is presented as a test method for conducting galvanic corrosion tests in a simulated physiological environment. Adherence to this test method should aid in avoiding some of the inherent difficulties in such testing. Other standards such as Guide G71 are general and, while they provide valuable background information, do not provide the necessary details or specificity for testing medical device implants.