1.1本指南阐述了非制造形式的原材料或原始材料的材料特性，这些原材料或原始材料最终将经过额外加工成为细胞或生物分子的生长、支撑或传递载体。本指南不适用于包装、灭菌和成品组织工程医疗产品。 1.2本指南的目的是帮助组织工程医疗产品的开发人员确定相关的现有标准和测试方法，并为不存在标准的材料的临时使用提供指导。

1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. This guide does not apply to packaged, sterilized, and finished tissue-engineered medical products. 1.2 The purpose of the guide is to assist the developer of tissue-engineered medical products to locate relevant existing standards and test methods and to provide guidance for interim use of materials for which a standard does not exist.