1.1 本文件提供了编写用于细胞和/或生物分子生长、支持或递送的组织工程支架的原料或起始材料的材料质量标准的指南。本指南不适用于已经处于支架形式或成品组织工程医疗产品的材料。 1.2 本指南的目的是提供医疗产品中常用材料的相关现有标准和检测方法的概要，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表征的潜在属性，包括聚合物、陶瓷、金属、复合材料以及人类、动物或植物来源的天然组织。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。它不包括安全性和生物相容性要求，因为安全性和生物相容性测试通常是对制成最终形式的材料进行的，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质量标准不一定能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 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》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 再生医学支架中使用的原料或起始材料的物理化学特性具有通过影响机械性能、化学反应、细胞行为和/或生物活性分子或药物的释放来影响产品性能的显著潜力。本指南描述了原材料或起始材料的推荐质量标准或表征，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。 4.2 在所有情况下，选择任何单一产品的规格时应主要考虑该产品的安全性和性能要求以及风险。本指南提供了一些典型的属性，这些属性并非都是必需的，也并不总是足够的。

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 potential attributes for 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. 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 ====== 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 mechanical properties, chemical reactions, 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. 4.2 In all cases, the specifications for any single product should be chosen with primary consideration to that product’s safety and performance requirements and risks. This guide provides typical attributes that will not all be necessary and will not always be sufficient.