1.1 本文件提供了用于细胞和/或生物分子生长、支持或输送的组织工程支架的原材料或起始材料的材料规范编写指南。本指南不适用于已形成支架形式或已完成组织工程医疗产品的材料。 1.2 本指南的目的是为医疗产品中已普遍使用的材料提供相关现有标准和测试方法的概要，并为不存在标准的原材料的临时使用提供表征指南。 1.3 本指南涵盖了所有主要材料类别的规格和特征，包括聚合物、陶瓷、金属、复合材料和人类、动物或植物来源的自然组织。 本指南不适用于药品。 1.4 本指南侧重于原材料或起始材料的化学、物理和机械性能的规范。它不包括安全和生物相容性要求，因为安全和生物相容性测试通常在制造成最终形式的材料上进行，以包括制造和灭菌技术的所有可能影响。 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。 ====意义和用途====== 4.1 再生医学支架中使用的原材料或起始材料的物理化学特性具有通过影响细胞行为和/或生物活性分子或药物释放来影响产品性能的巨大潜力。本指南描述了原材料或起始材料的推荐规格或特征，以确保其在制造成可植入组织工程支架和/或控释基质之前的再现性。

1.1 This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are finished tissue-engineered medical products. 1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials for which a standard does not exist. 1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals. 1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques. 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. ====== Significance And Use ====== 4.1 The physico-chemical characteristics of the raw or starting material used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting materials to ensure reproducibility prior to their fabrication into implantable tissue-engineering scaffolds and/or controlled release matrices.