ASTM F2603-06(2020)

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.

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.

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.