1. Scope

1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore size distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and for providing reliable quality control data.

1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 This guide 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 and health practices and to determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry

D4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry

E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use

E1294 Test Method for Pore Size Characteristics of Membrane Filters Using Automated Liquid Porosimeter

E1441 Guide for Computed Tomography (CT) Imaging

F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test

F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

F2603 Guide for Interpreting Images of Polymeric Tissue Scaffolds

Keywords

microstructure; pore size; pore volume; porosity; porous materials; tissue scaffolds; Polymeric scaffolds; Tissue engineered medical products (TEMPs) ;

ICS Code

ICS Number Code 11.100 (Laboratory medicine)

DOI: 10.1520/F2450-09

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