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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E1919 Guide for Worldwide Published Standards Relating to Particle and Spray Characterization
E2245 Test Method for Residual Strain Measurements of Thin, Reflecting Films Using an Optical Interferometer
F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1877 Practice for Characterization of Particles
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 37.040.99 (Other standards related to photography)
UNSPSC Code 30191611(Scaffolding fixation device)