ASTM F3259-17R25

1.1 This guide is a resource for conducting micro-computed tomography (microCT) imaging and analysis of porous scaffolds for tissue engineering applications. Considerations are provided for sample preparation, image acquisition parameter selection, post-processing, and data interpretation.

1.2 The information in this guide is intended to be applicable to products that include a porous scaffold component and are designed for tissue engineering repair strategies. The scaffolds may be fabricated from synthetic polymers (e.g., absorbable polyesters) or natural materials (e.g., calcium phosphates), mammalian or human-derived materials (e.g., demineralized bone), or combinations of these. While some considerations are provided for imaging of materials that are of moderate to high radiodensity, specific guidelines are not provided for imaging metallic scaffolds.

1.3 Applicability of the guidelines herein will depend on scaffold material type and the user’s application (e.g., experimental design, as-manufactured characterization) as appropriate.

1.4 The guidelines for microCT discussed herein are most suitable for specimen scanning in vitro. Specific guidelines relevant to direct in vivo imaging of scaffolds are not included because the imaging parameters will be dependent on the implantation site, animal size, breathing, etc. In addition, consensus recommendations for in vivo imaging are provided in Bouxsein et al., 2010 (1).2 While the specific imaging parameters and processing recommendations discussed in Bouxsein et al. are specific to bone imaging, many of the considerations and precautions are also applicable for in vivo scaffold imaging.

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

1.6 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.

1.7 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.