1.1 本规程描述了金属外科植入物的表面特征、表面处理和标记，旨在提高植入物表面和标记的耐腐蚀性。 1.2 本规程中未规定标记命名和内毒素中和（见 X1.4 ). 1.3 适当时，植入物规范中包含的表面要求和标记方法应优先于本规程中列出的要求。 1.4 以国际单位制或英寸表示的数值- 磅单位应单独视为标准单位。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====== 3.1 本规程中记录的表面处理的目的是提高金属外科植入物的耐腐蚀性，包括但不限于由铁、钴、镍、钛和钽基材料制成的植入物。 3.2 在成型、机加工、翻滚、介质喷砂、标记等加工操作过程中，铁颗粒、陶瓷介质和其他外来颗粒可能会被涂抹或嵌入植入物表面。应去除这些颗粒，以尽量减少局部腐蚀和表面瑕疵。 3.3 本规程规定的各种化学和电化学表面处理用于去除不良表面污染物，并恢复对惰性或被动表面（如适用于特定材料的金属氧化膜）的最大耐腐蚀性，或促进其形成。 其中一些处理被称为钝化处理。给定应用的首选表面处理取决于植入材料和表面污染物的性质。 3.4 根据植入物、其材料以及标记方法和程序的类型，可以在化学或电化学表面处理之前或之后进行标记。表面处理后进行标记时，应评估局部植入物表面，以确定是否需要额外的表面处理。 注1: 当标记方法涉及直接或间接接触铁基材料或其他被视为有害表面污染物的材料时，所有标记方法的不锈钢和有色合金可能需要额外的表面处理。 3.5 植入物生产规范中可能包括应用于植入物的程序选择以及本规程未涵盖的其他要求。

1.1 This practice provides descriptions of surface characteristics, surface preparation, and marking for metallic surgical implants, with the purpose of improving the corrosion resistance of the implant surfaces and markings. 1.2 Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.4 ). 1.3 Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate. 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 ====== 3.1 The objective of surface treatments as documented in this practice is to improve the corrosion resistance of metallic surgical implants including, but not limited to, those manufactured from iron, cobalt, nickel, titanium, and tantalum base materials. 3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or embedded into the surface of implants during processing operations such as forming, machining, tumbling, media blasting, marking, and so forth. These particles should be removed to minimize localized corrosion and superficial blemishes. 3.3 The various chemical and electrochemical surface treatments specified by this practice are used to remove objectionable surface contaminants and to restore maximum corrosion resistance to, or promote the creation of, an inert or passive surface, such as a metal oxide film, as is applicable to the specific material. Some of these treatments are referred to as passivation treatments. The preferred surface treatment for a given application varies depending on the implant material and the nature of the surface contaminants. 3.4 Depending on the implant, its material, and the type of marking method and procedure, the marking may be applied before or after a chemical or electrochemical surface treatment. When marking is performed after the surface treatment, the localized implant surface shall be evaluated to determine if there is a need for additional surface treatment. Note 1: The need for additional surface treatment is likely for stainless steel with all marking methods, and for nonferrous alloys when the marking method involves direct or second-hand contact with iron-based or other material that would be considered an objectionable surface contaminant. 3.5 The selection of procedures to be applied to the implants, and additional requirements which are not covered by this practice, may be included in the implant production specification.