Standard Active Last Updated: Oct 13, 2025 Track Document
ASTM F3259-17(2025)

Standard Guide for Micro-computed Tomography of Tissue-Engineered Scaffolds

Standard Guide for Micro-computed Tomography of Tissue-Engineered Scaffolds F3259-17R25 ASTM|F3259-17R25|en-US Standard Guide for Micro-computed Tomography of Tissue-Engineered Scaffolds Standard new BOS Vol. 13.02 Committee F04
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Significance and Use

4.1 X-ray microcomputed tomography (microCT) is a nondestructive three-dimensional imaging method that can be used to reconstruct the microarchitecture of a tissue-engineered medical product (TEMP) scaffold that may or may not contain ingrown tissue. MicroCT was first developed to study ceramics for the auto industry and adapted for bone morphology at the microscale (Feldkamp et al., 1989) (2). More recently, the imaging method has been adapted for in vivo applications and studies of multiple natural and synthetic materials.

4.2 Alternate characterization methods for assessing scaffold microarchitecture and tissue ingrowth are limited by their two-dimensional nature (e.g., microscopy) and low depth of penetration (e.g., optical coherence tomography), even though their resolution may be increased over microCT. However, microCT is an ideal imaging choice for studying scaffold microarchitecture and tissue ingrowth because it is nondestructive, provides scaffold assessments based on direct measurements rather than stereological methods, offers the ability to perform longitudinal imaging, and can be conducted at length scales relevant to cells and cell attachment (i.e., 1 micron to hundreds of microns).

4.3 The microarchitecture of tissue-engineered scaffolds plays a critical role in providing structural support and/or facilitating cell adhesion, proliferation, and phenotype as well as matrix deposition. These parameters are essential elements of the tissue engineering strategy. During scaffold degradation, either in vitro or in vivo, changes to the microarchitecture continue to influence the eventual tissue repair. Therefore, it is critical to characterize the microarchitecture over time. Such characterization can aid the optimal design of TEMP scaffolds, establishment of manufacturing consistency, and monitoring of scaffold structure and/or tissue response.

4.4 This guide provides a compendium of information related to the use of microCT for the structural assessment of scaffold microarchitecture and tissue ingrowth. While the microarchitecture of tissue-engineered scaffolds as well as changes to it over time can be assessed using multiple methods (e.g., such as those described in Guide F2450), this guide focuses on unique considerations for conducting the microCT analyses.

4.5 The user of this guide is provided with considerations for each aspect of a complete microCT study including sample preparation, image acquisition, assessing image quality and artifacts, post-processing, and image interpretation based on the specific application.

4.6 This standard provides imaging and analysis considerations for the following broad types of applications: (a) scaffold microarchitecture analysis in vitro either before or after different stages of degradation, (b) ex vivo analysis of scaffold microarchitecture following partial degradation in an in vivo animal model, (c) deriving microarchitectural information when multiple materials are used in the scaffold, and (d) differentiating between scaffold microarchitectural changes and new tissue ingrowth.

4.7 The information provided in this standard guide is not intended as a test method for microCT characterization because the user’s specific application and experimental design will significantly influence the imaging methodology and interpretation.

Scope

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.

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Details
Book of Standards Volume: 13.02
Developed by Subcommittee: F04.42
Pages: 15
DOI: 10.1520/F3259-17R25
ICS Code: 11.100.99