1.1 本指南涵盖了获取和解释组织支架图像时需要考虑的因素，包括技术选择、仪器分辨率和图像质量、量化和样品制备。 1.2 本指南中的信息旨在适用于多孔聚合物基组织支架，包括天然衍生材料，如胶原蛋白。然而，一些材料（合成材料和天然材料）可能需要独特或不同的样品制备方法，本指南中未具体涵盖这些方法。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 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。 1.5 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====== 4.1 本文件为希望从包括高含水量凝胶和编织纺织品的聚合物制造的组织支架的图像中获得可量化数据的用户提供了指导。 4.2 从组织支架图像中获得的信息可用于优化特定应用中基质的结构特征，开发更好的制造程序，或提供质量保证和产品可追溯性的措施。 图1 概述了图像捕获和分析的关键阶段。 图1 图像捕获、存储和分析的关键阶段 4.3 组织支架中的孔隙分析与颗粒分析之间存在协同作用，这反映在引用的标准和第节中描述的分析中 9 . 指导 E1919 提供颗粒分析标准概要，包括测量技术、数据分析和采样方法。

1.1 This guide covers the factors that need to be considered in obtaining and interpreting images of tissue scaffolds including technique selection, instrument resolution and image quality, quantification and sample preparation. 1.2 The information in this guide is intended to be applicable to porous polymer-based tissue scaffolds, including naturally derived materials such as collagen. However, some materials (both synthetic and natural) may require unique or varied sample preparation methods that are not specifically covered in this guide. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 This document provides guidance for users who wish to obtain quantifiable data from images of tissue scaffolds manufactured from polymers that include both high water content gels and woven textiles. 4.2 Information derived from tissue scaffold images can be used to optimize the structural characteristics of the matrix for a particular application, to develop better manufacturing procedures or to provide a measure of quality assurance and product traceability. Fig. 1 provides a summary of the key stages of image capture and analysis. FIG. 1 Key Stages in Image Capture, Storage, and Analysis 4.3 There is a synergy between the analysis of pores in tissue scaffolds and that of particles that is reflected in standards cited and in the analysis described in Section 9 . Guide E1919 provides a compendium of standards for particle analysis that includes measurement techniques, data analytical and sampling methodologies.