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现行 ASTM F746-04(2021)
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Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials 金属外科植入材料的点蚀或缝隙腐蚀的标准试验方法
发布日期: 2021-08-01
1.1 本试验方法包括测定用于生产外科植入物的金属和合金的抗点蚀或缝隙腐蚀性。它是已建立测试的修改版本 2. 并用作筛选试验,按耐局部腐蚀性对外科植入物合金进行排序。 1.2 本试验方法仅适用于被动金属和合金。非惰性合金(贵合金除外)易受一般腐蚀,通常不适合植入物使用。 1.3 本试验方法旨在用作经受点蚀或缝隙腐蚀或两者兼有的金属和合金的实验室筛选试验。 1.4 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可能不是精确的等效值;因此,每个系统应相互独立使用。将两个系统的值合并可能会导致不符合标准。 1.5 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。 1.6 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《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 本试验方法仅用于确定比较实验室性能指标。结果可用于在该方法的特定条件下对合金进行排序,以提高抗点蚀和缝隙腐蚀的能力。应注意,该方法旨在达到足以导致至少一种合金(316型)击穿的条件 L不锈钢)目前被认为可用于外科植入物,并且在试验更严重部分遭受点蚀或缝隙腐蚀的合金在作为外科植入物放置在人体内时不一定遭受局部腐蚀。
1.1 This test method covers the determination of resistance to either pitting or crevice corrosion of metals and alloys from which surgical implants will be produced. It is a modified version of an established test 2 and is used as a screening test to rank surgical implant alloys in order of their resistance to localized corrosion. 1.2 This test method applies only to passive metals and alloys. Nonpassive alloys (other than noble alloys) are susceptible to general corrosion and are not normally suitable for implant use. 1.3 This test method is intended for use as a laboratory screening test for metals and alloys which undergo pitting or crevice corrosion, or both. 1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the 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 is designed solely for determining comparative laboratory indices of performance. The results may be used for ranking alloys in order of increasing resistance to pitting and crevice corrosion under the specific conditions of this method. It should be noted that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown of at least one alloy (Type 316 L stainless steel) currently considered acceptable for surgical implant use, and that those alloys which suffer pitting or crevice corrosion during the more severe portions of the test do not necessarily suffer localized corrosion when placed within the human body as a surgical implant.
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归口单位: F04.15
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