1.1 本指导文件提供了冶金特性信息，这些信息可能有助于评估医用植入物应用的可吸收金属材料。本指南主要针对经过进一步加工制成最终器件的可吸收金属材料。因此，本标准不要求在最终设备上进行更合适的评估，如生物评估。然而，出于信息目的，包含了一些关于成品植入装置的相关标准。 1.2 本指南的目的是确定适当的测试方法和相关医疗产品标准，这些方法和标准可用于制定新的或改性可吸收金属材料的未来标准。 1.3 本指南无意涵盖其他主要类别的可吸收材料，如聚合物、陶瓷、复合材料和组织- 工程材料。 1.4 本标准指南的重点是化学、物理、微观结构和机械性能，以及用于医疗植入物的金属材料的检查指南，这些金属材料在一段时间内被人体吸收。本指南侧重于材料特性，不涉及确定植入物安全性和功能性所需的特定于设备的机械测试。 1.5 符合根据本标准制定的材料规范不一定会产生适合其预期用途的材料。可能需要针对预期用途进行额外测试。 1.6 由于医用植入物的表面改性通常应用于制造的后期阶段，本标准指南不涵盖可吸收或非可吸收材料的特性- 来源于金属（如氧化物）或添加其他材料（如陶瓷或聚合物）的可吸收表面涂层。然而，本标准适用于可吸收金属材料，无论是否有涂层。 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====== 5.1 用于制造可吸收金属植入物的材料的冶金性能会影响生物反应以及与体内软组织和硬组织的机械相互作用。本标准指南描述了可吸收金属材料的建议材料表征方案，以确保其在制造成医用植入物之前的性能再现性。

1.1 This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic materials that undergo further processing into a fabricated final device. Therefore, this standard does not require assessments that are more appropriately conducted on the final device, such as biological evaluation. However, a few relevant standards for finished implant devices are included for information purposes. 1.2 The purpose of this guide is to identify appropriate test methods and relevant medical product standards that can be used to develop future standards for new or modified absorbable metallic materials. 1.3 This guide is not intended to cover other major classes of absorbable materials such as polymers, ceramics, composites, and tissue-engineered materials. 1.4 This standard guide is focused on the chemical, physical, microstructural, and mechanical properties plus inspection guidelines for metallic materials that are used for medical implants designed to be absorbed in the body over a period of time. This guide focuses on material characterizations and does not address device specific mechanical testing that may be necessary to determine safety and functionality of the implant. 1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required. 1.6 Since surface modifications of medical implants are generally applied in the latter stages of manufacturing, this standard guide does not cover the characterization of either absorbable or non-absorbable surface coatings that are metallic in origin such as oxides or from the addition of other materials such as ceramics or polymers. However, this standard does apply to absorbable metallic materials, regardless of the presence or absence of a coating. 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 ====== 5.1 The metallurgical properties of materials used to manufacture absorbable metallic implants can influence biological reactions and mechanical interaction with soft and hard tissue in the body. This standard guide describes a suggested material characterization scheme for absorbable metallic materials to ensure reproducibility of properties prior to their manufacture into medical implants.