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ASTM F2952-14

(Guide)

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

SIGNIFICANCE AND USE
4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.  
4.2 The technique is not sensitive to the presence of closed or blind-end pores (Fig. 1).  
4.3 Values of the permeability coefficient can be used to compare the consistency of manufactured samples or to determine what the effect of changing one or more manufacturing settings has on permeability. They can also be used to assess the homogeneity and anisotropy of tissue scaffolds. Variability in the permeability coefficient can be also be indicative of:  
4.3.1 Internal damage within the sample e.g., cracking or permanent deformation.  
4.3.2 The presence of large voids, including trapped air bubbles, within the structure.  
4.3.3 Surface effects such as a skin formed during manufacture.  
4.3.4 Variable sample geometry.  
4.4 This test method is based on the assumption that the flow rate through a given sample subjected to an applied pressure gradient is constant with time.Note 1—If a steady state flow condition isn’t reached, then this could be due to structural damage (i.e., crack formation or the porous structure deformed as a result of the force being placed upon it by the fluid flowing through it). Sample deformation in the form of stretching (bowing) can also occur for less resilient structures as a result of high fluid flow rates. This topic is discussed in more detail in Section 7.  
4.5 Care should be taken to ensure that hydrophobic materials are fully wetted out when using water or other aqueous-based liquids as permeants.  
4.6 Conventionally, the pressure differential created across a sample is measured as a function of both increasing and decreasing flow rates. An alternative approach, whi...
SCOPE
1.1 This guide describes test methods suitable for determining the mean Darcy permeability coefficient for a porous tissue scaffold, which is a measure of the rate at which a fluid, typically air or water, flows through it in response to an applied pressure gradient. This information can be used to optimize the structure of tissue scaffolds, to develop a consistent manufacturing process, and for quality assurance purposes.  
1.2 The method is generally non-destructive and non-contaminating.  
1.3 The method is not suitable for structures that are easily deformed or damaged. Some experimentation is usually required to assess the suitability of permeability testing for a particular material/structure and to optimize the experimental conditions.  
1.4 Measures of permeability should not be considered as definitive metrics of the structure of porous tissue scaffolds and should complement measures obtained by other investigative techniques e.g., scanning electron microscopy, gas flow porometry and micro-computer x-ray tomography (ASTM F2450).  
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
28-Feb-2014
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

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ASTM F2952-14 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue ScaffoldASTM F2952-14 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
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ASTM F2952-14 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2952 − 14
Standard Guide for
Determining the Mean Darcy Permeability Coefficient for a
1
Porous Tissue Scaffold
This standard is issued under the fixed designation F2952; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2603 Guide for Interpreting Images of Polymeric Tissue
Scaffolds
1.1 This guide describes test methods suitable for determin-
3
2.2 American Petroleum Institute (API) Document:
ing the mean Darcy permeability coefficient for a porous tissue
RP-27 RecommendedPracticeforDeterminingPermeability
scaffold, which is a measure of the rate at which a fluid,
of Porous Media
typicallyairorwater,flowsthroughitinresponsetoanapplied
pressure gradient.This information can be used to optimize the
3. Terminology
structure of tissue scaffolds, to develop a consistent manufac-
turing process, and for quality assurance purposes. 3.1 Definitions:
3.1.1 tortuosity, n—the ratio of the actual path length
1.2 The method is generally non-destructive and non-
through connected pores to the Euclidean distance (shortest
contaminating.
linear distance).
1.3 The method is not suitable for structures that are easily
deformed or damaged. Some experimentation is usually re-
4. Significance and Use
quired to assess the suitability of permeability testing for a
4.1 This document describes the basic principles that need
particular material/structure and to optimize the experimental
to be followed to obtain a mean value of the Darcy permeabil-
conditions.
ity coefficient for structures that consist of a series of intercon-
1.4 Measures of permeability should not be considered as
nected voids or pores. The coefficient is a measure of the
definitivemetricsofthestructureofporoustissuescaffoldsand permeability of the structure to fluid flowing through it that is
should complement measures obtained by other investigative
driven by a pressure gradient created across it.
techniquese.g.,scanningelectronmicroscopy,gasflowporom-
4.2 The technique is not sensitive to the presence of closed
etry and micro-computer x-ray tomography (ASTM F2450).
or blind-end pores (Fig. 1).
1.5 This standard does not purport to address all of the
4.3 Values of the permeability coefficient can be used to
safety concerns, if any, associated with its use. It is the
compare the consistency of manufactured samples or to deter-
responsibility of the user of this standard to establish appro-
mine what the effect of changing one or more manufacturing
priate safety and health practices and determine the applica-
settings has on permeability. They can also be used to assess
bility of regulatory limitations prior to use.
the homogeneity and anisotropy of tissue scaffolds. Variability
in the permeability coefficient can be also be indicative of:
2. Referenced Documents
4.3.1 Internal damage within the sample e.g., cracking or
2
2.1 ASTM Standards:
permanent deformation.
D4525 Test Method for Permeability of Rocks by Flowing
4.3.2 The presence of large voids, including trapped air
Air
bubbles, within the structure.
F2450 Guide for Assessing Microstructure of Polymeric
4.3.3 Surface effects such as a skin formed during manu-
Scaffolds for Use in Tissue-Engineered Medical Products
facture.
4.3.4 Variable sample geometry.
1 4.4 This test method is based on the assumption that the
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
flow rate through a given sample subjected to an applied
F04.42 on Biomaterials and Biomolecules for TEMPs.
pressure gradient is constant with time.
Current edition approved March 1, 2014. Published April 2014. DOI: 10.1520/
NOTE 1—If a steady state flow condition isn’t reached, then this could
F2952-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from American Petroleum Institute (API), 1220 L. St., NW,
the ASTM website. Washington, DC 20005-4070, http://www.api.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2952 − 14
FIG. 1 Schematic of the Different Pores Types Found in Tissue Scaffolds.
Fluid Flow through the Structure is via the Open Pores
4
be due to structural damage (i.e., crack formation or the porous structure
gases can move (1). In most cases, the material used to create
deformed as a
...

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4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.  
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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:  
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FDA/CDRH CFR and Guidances:  
21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.  
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...

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ASTM
ASTM F619-20(Practice)
Standard Practice for Extraction of Materials Used in Medical Devices

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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