1.1 本指南是用于组织工程医疗产品（TEMP）的基于纤维的结构表征的资源。现有标准以更普遍的方式广泛涵盖支架（指南 F2150 , F2450 , F2900 , F2902 ，ISO 21560）。本指南特别关注基于光纤的结构。 1.2 基于纤维的结构可以通过多种不同的方法制造，包括但不限于以下方法:静电纺丝、强制纺丝、熔融纺丝、气动纺丝、吹塑纺丝、熔融电写入、熔融挤出、湿挤出、熔融沉积、液晶沉积、电化学对准、拉伸、纺丝、编织、编织、粉末床融合（激光烧结），还原型光聚合（立体光刻）、粘合剂喷射、定向能沉积、自组装（例如，纤维生成）和混合方法。本文件旨在论述通过任何这些方法制成的纤维，尽管在某些章节中对静电纺丝纤维进行了更详细的论述。 1.3 本指南将重点介绍由平均纤维直径在约100 nm至100µm范围内的纤维制成的结构。 1.4 在本标准中，“基于纤维的结构”被定义为由细长长丝组成的结构。 1.5 单位- 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 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 本文包含的测试方法指导了基于纤维的结构的结构、物理、化学、机械和生物特性的表征。这些特性对于TEMP的成功可能很重要，尤其是当它们影响细胞保留时；活动和组织；抗拉强度；生物活性剂的输送；或构建物的生物相容性和生物活性。 5.2 本文所述测试可用于制造过程中的质量控制或评估产品如何发挥其预期临床功能。 5.3 应与适当的监管机构讨论产品开发、产品特性和监管途径的计划。

1.1 This guide is a resource for the characterization of fiber-based constructs intended for use in a tissue-engineered medical product (TEMP). There are existing standards that broadly cover scaffolds in a more generalized fashion (Guides F2150 , F2450 , F2900 , F2902 , ISO 21560). This guide focuses specifically on fiber-based constructs. 1.2 Fiber-based constructs may be fabricated by many different methods including, but not limited to the following: electrospinning, forcespinning, meltspinning, pneumatospinning, blowspinning, melt-electrowriting, melt extrusion, wet extrusion, fused deposition, liquid crystal deposition, electrochemical alignment, drawing, spinning, knitting, weaving, braiding, powder bed fusion (laser sintering), vat photopolymerization (stereolithography), binder jetting, directed energy deposition, self-assembly (for example, fibrillogenesis), and hybrid approaches. This document is intended to address fibers made by any of these methods, although electrospun fibers are addressed in greater detail in some sections. 1.3 This guide will focus on constructs made of fibers wherein the average fiber diameter is within the range of approximately 100 nm to 100 µm. 1.4 For the purposes of this standard, a “fiber-based construct” is defined as a construct composed of slender, elongated filaments. 1.5 Units— The values stated in SI units are to be regarded as the standard. No other units of measurement are included 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 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention; activity and organization; tensile strength; the delivery of bioactive agents; or the biocompatibility and bioactivity of the construct. 5.2 Tests described herein may be used for quality control during manufacturing or to assess how the product may perform its intended clinical function. 5.3 Plans for product development, product characterization, and the regulatory pathway should be discussed with the appropriate regulatory body.