【国外标准】 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants

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.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.