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ASTM F3259-17

(Guide)

Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds

Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds

General Information

Status
Published
Publication Date
30-Apr-2017
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Refers
ASTM F2450-18 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
Effective Date
15-Nov-2018
Refers
ASTM F2603-06(2020) - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
Effective Date
01-Aug-2020
Referred By
ASTM F2952-22 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
Effective Date
01-May-2017
Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
01-May-2017

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ASTM F3259-17 - Standard Guide for Micro-computed Tomography of Tissue Engineered ScaffoldsASTM F3259-17 - Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
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ASTM F3259-17 - Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
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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.
Designation: F3259 − 17
Standard Guide for
Micro-computed Tomography of Tissue Engineered
1
Scaffolds
This standard is issued under the fixed designation F3259; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 Thisguideisaresourceforconductingmicro-computed
responsibility of the user of this standard to establish appro-
tomography (microCT) imaging and analysis of porous scaf-
priate safety and health practices and determine the applica-
folds for tissue engineering applications. Considerations are
bility of regulatory limitations prior to use.
provided for sample preparation, image acquisition parameter
1.7 This international standard was developed in accor-
selection, post-processing, and data interpretation.
dance with internationally recognized principles on standard-
1.2 The information in this guide is intended to be appli-
ization established in the Decision on Principles for the
cabletoproductsthatincludeaporousscaffoldcomponentand
Development of International Standards, Guides and Recom-
are designed for tissue engineering repair strategies. The
mendations issued by the World Trade Organization Technical
scaffolds may be fabricated from synthetic polymers (e.g.,
Barriers to Trade (TBT) Committee.
absorbable polyesters) or natural materials (e.g., calcium
phosphates), mammalian or human derived materials (e.g.,
2. Referenced Documents
demineralized bone) or combinations of these. While some
3
2.1 ASTM Standards:
considerationsareprovidedforimagingofmaterialsthatareof
F2450Guide for Assessing Microstructure of Polymeric
moderate to high radiodensity, specific guidelines are not
Scaffolds for Use in Tissue-Engineered Medical Products
provided for imaging metallic scaffolds.
F2603Guide for Interpreting Images of Polymeric Tissue
1.3 Applicability of the guidelines herein will depend on
Scaffolds
scaffold material type and the user’s application (e.g., experi-
mental design, as manufactured characterization) as appropri-
3. Terminology
ate.
3.1 Definitions of Terms Specific to This Standard:
1.4 The guidelines for microCT discussed herein are most
3.1.1 microarchitecture, n—the set of structural features of
suitable for specimen scanning in vitro. Specific guidelines
an object defined at the microscale.
relevant to direct in vivo imaging of scaffolds are not included
3.1.2 volume of interest (VOI), n—a 3D sub-volume inside
because the imaging parameters will be dependent on the
an image that contains the features to be analyzed.
implantation site, animal size, breathing etc. In addition,
consensus recommendations for in vivo imaging are provided
4. Significance and Use
2
in Bouxsein et al 2010 (1). While the specific imaging
4.1 X-ray microcomputed tomography (microCT) is a non-
parameters and processing recommendations discussed in
destructivethree-dimensionalimagingmethodthatcanbeused
Bouxsein et al are specific to bone imaging, many of the
to reconstruct the microarchitecture of a tissue engineered
considerations and precautions are also applicable for in vivo
medical product (TEMP) scaffold that may or may not contain
scaffold imaging.
ingrowntissue.MicroCTwasfirstdevelopedtostudyceramics
1.5 The values stated in SI units are to be regarded as
for the auto-industry and adapted for bone morphology at the
standard. No other units of measurement are included in this
microscale (Feldkamp et al 1989) (2). More recently, the
standard.
imaging method has been adapted for in vivo applications and
studies of multiple natural and synthetic materials.
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.42 on Biomaterials and Biomolecules for TEMPs.
3
Current edition approved May 1, 2017. Published September 2017. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F3259-17. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3    
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58    
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SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.  
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).  
5.4 Caution should be exercised in the understanding and intent of this practice as follows:  
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.  
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.  
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.  
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 thi...

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ASTM
ASTM F719-20e1(Practice)
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard may involve hazardous materials, operations, and equipment. 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.  
1.5 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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