1.1 通过监测与物理和生物特性相关的特征，可以使TEMP中使用的支架的一致功能更加可预测。本指南可用于选择干燥离子凝胶海藻酸钠泡沫支架的合适测试方法，该支架可能是医疗器械的一个组件或被视为医疗器械本身。 1.2 本指南提供了海藻酸钠泡沫支架物理测试的相关信息，如机械性能、水化性能、孔结构和支架降解。 此外，还概述了与生物特性相关的问题，如元素杂质、细菌生物负载、细菌内毒素、无菌和生物相容性。 1.3 本指南旨在与用于制造海藻酸钠泡沫的任何原材料或起始材料的适当表征和评估一起使用，如指南中所述 F2027 和 F2064 . 1.4 本指南介绍了含或不含生物活性剂或生物活性的海藻酸钠泡沫支架。 本指南不涉及与支架结合使用的任何生物分子、细胞、药物或生物活性剂的表征或释放曲线。 1.5 本标准仅使用国际单位制。 1.6 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。 1.7 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 本指南是组织工程医疗产品中使用的海藻酸钠泡沫支架的表征和测试指南。海藻酸钠泡沫支架可用于许多组织工程和再生医学应用，例如抗肿瘤药物- 粘附、内部伤口愈合和引导组织再生。此外，海藻酸钠泡沫可以用作基于细胞的细胞治疗和释放生物活性剂的基质。

1.1 Consistent functionality of scaffolds used in TEMPs can be made more predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in the selection of suitable test methods of dried ionically gelled alginate foam scaffolds that may be a component of a medical device or considered a medical device itself. 1.2 This guide provides information relevant for the physical testing of alginate foam scaffolds such as mechanical properties, hydration properties, pore structure, and scaffold degradation. In addition, issues related to biological properties such as elemental impurities, bacterial bioburden, bacterial endotoxins, sterility, and biocompatibility are outlined. 1.3 This guide is intended to be used in conjunction with appropriate characterization and evaluation of any raw or starting materials utilized for fabrication of the alginate foam, such as described in Guides F2027 and F2064 . 1.4 This guide addresses alginate foam scaffolds with and without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. 1.5 Only SI units are used in this standard. 1.6 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. 1.7 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 This guide is a guideline for the characterizing and testing of alginate foam scaffolds used in tissue-engineered medical products. Alginate foam scaffolds can be used in a number of tissue engineering and regenerative medicine applications such as anti-adhesion, internal wound healing, and guided tissue regeneration. In addition, alginate foam can be used as a matrix for cell-based cell therapies and for the release of bioactive agents.