ASTM F2450-04 - 1.11.2004
 
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.

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

F2150-19

Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

F316-03(2019)

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

F2603-06(2020)

Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

E1441-19

Standard Guide for Computed Tomography (CT)

D2873-94(1999)e1

Standard Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry (Withdrawn 2003)

E128-99(2019)

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

E1294-89(1999)

Standard Test Method for Pore Size Characteristics of Membrane Filters Using Automated Liquid Porosimeter (Withdrawn 2008)

D4404-18

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