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ASTM F3088-14

(Test Method)

Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

SIGNIFICANCE AND USE
4.1 This test method describes a cell adhesion method that can be used to provide a detachment percent at a given RCF for cells that have adhered to a substrate, typically for a short time. The information generated by this test method can be used to obtain a semi-quantitative measurement of the adhesion of cells to either an uncoated or pre-coated substrate, when compared to a reference (adherent) cell type on the same substrate. As described in Reyes and Garcia (2003), it is recommended that the 50 % point be used for either ligand concentration or RCF for the most robust measurement of adhesion strength. The adhesion may vary due to changes in the phenotype of the cells or as a result of the specific properties of the surface. The substrate may include tissue culture-treated polystyrene, biomaterials or bioactive surfaces. If the substrate is a hydrogel, care must be taken to avoid cohesive failure in the hydrogel (that is, detached cells have pulled away fragments of gel). The coating may consist of (but is not limited to) the following: natural or synthetic biomaterials, hydrogels, components of extracellular matrix (ECM), ligands, adhesion or bioactive molecules, genes or gene products. Cell concentration is also critical, as use of too high a concentration of cells may result in cells detaching as a sheet, rather than as individual cells. This centrifugation approach, once validated, may be applicable for quality control (QC) and product development. However, until the method is correlated to other measures of cell attachment, the current method should be run in parallel with other known measures of cell adhesion.  
4.2 This test method does not cover test methods to quantitate changes in gene expression, or changes in biomarkers, as identified by immunostaining. This test method additionally does not cover quantitative image analysis techniques. In some cases the change in adhesive properties may reflect on the degree of differentiation or de-differentiatio...
SCOPE
1.1 This test method covers a centrifugation cell adhesion assay that can be used to detect changes in adhesive characteristics of cells with passage or treatments. This approach measures the force required to detach cells from a substrate. Adhesion, among many variables, may vary due to changes in the phenotype of the cells.  
1.2 This test method does not cover methods to verify the uniformity of coating of surfaces, nor does it cover methods for characterizing surfaces.  
1.3 The cells may include adult, progenitor or stem cells from any species. The types of cells may include chondrocytes, fibroblasts, osteoblast, islet cells, or other relevant adherent cell types.  
1.4 This test method does not cover methods for isolating or harvesting of cells. This test method does not cover test methods to quantitate changes in gene expression, or changes in biomarker type or concentration, as identified by immunostaining. Nor does this test method cover quantitative image analysis techniques.  
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
30-Apr-2014
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.43 - Cells and Tissue Engineered Constructs for TEMPs
Current Stage
Ref Project

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ASTM F3088-14 - Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive InteractionsASTM F3088-14 - Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
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ASTM F3088-14 - Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
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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: F3088 − 14
Standard Test Method for
Use of a Centrifugation Method to Quantify/Study Cell-
1
Material Adhesive Interactions
This standard is issued under the fixed designation F3088; 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 F2739Guide for Quantitating Cell Viability Within Bioma-
terial Scaffolds
1.1 This test method covers a centrifugation cell adhesion
F2944Test Method for Automated Colony Forming Unit
assay that can be used to detect changes in adhesive charac-
(CFU) Assays—Image Acquisition and Analysis Method
teristics of cells with passage or treatments. This approach
forEnumeratingandCharacterizingCellsandColoniesin
measures the force required to detach cells from a substrate.
Culture
Adhesion, among many variables, may vary due to changes in
the phenotype of the cells.
3. Summary of Test Method
1.2 This test method does not cover methods to verify the
3.1 Centrifugation Cell Assay on Cell Populations—Acon-
uniformityofcoatingofsurfaces,nordoesitcovermethodsfor
ventional centrifuge can be used to apply a normal or shear
characterizing surfaces.
force to cells depending on the orientation of the cells with
3
respect to the centrifugal force (1-3). The centrifugal force
1.3 The cells may include adult, progenitor or stem cells
that the cells are subject to can be calculated according to the
fromanyspecies.Thetypesofcellsmayincludechondrocytes,
following formula assuming that the plates are 90° (normal) to
fibroblasts,osteoblast,isletcells,orotherrelevantadherentcell
the spindle of the centrifuge.
types.
F 5 p 2 p V RCF (1)
~ !
1.4 Thistestmethoddoesnotcovermethodsforisolatingor
D cell medium cell
harvesting of cells. This test method does not cover test
where:
methods to quantitate changes in gene expression, or changes
F = detachment force applied per cell,
D
in biomarker type or concentration, as identified by immunos-
V = cell volume,
cell
taining. Nor does this test method cover quantitative image
p = density of the cell,
cell
analysis techniques.
p = the density of the surrounding medium, and
medium
2
1.5 This standard does not purport to address all of the
RCF = Relative Centrifugal Forces = rῳ , where r =
safety concerns, if any, associated with its use. It is the centrifugationradiusandῳ=centrifugationspeed.
responsibility of the user of this standard to establish appro-
See X1.6 for example of a calculation of “detachment force
priate safety and health practices and determine the applica-
per cell.”
bility of regulatory limitations prior to use.
3.1.1 Suchtestsareeasytoconductandtheresultsrepresent
a population average. The method can be performed in a
2. Referenced Documents
moderately outfitted cell biology lab with an inverted micro-
2
2.1 ASTM Standards:
scopeorafluorescencemicroplatereaderandacentrifugewith
F2603Guide for Interpreting Images of Polymeric Tissue
a microtiter plate holder. Three factors need to be considered
Scaffolds
whenusingthismethodology:thepotentialinfluencesofforces
F2664Guide for Assessing the Attachment of Cells to
applied during the period of spin up time, the maximum spin
Biomaterial Surfaces by Physical Methods
speed, and the test duration. The method is only able to
correlatewithcelldetachmentwiththemaximumforceapplied
afterthecentrifugehasreacheditssetspinspeed.Itshouldalso
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
be considered that the maximum force that can be applied is
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
limited by the centrifuge, sample configuration (that is, con-
F04.43 on Cells and Tissue Engineered Constructs for TEMPs.
Current edition approved May 1, 2014. Published June 2014. DOI: 10.1520/ figuration and type of multiwell plate) and time of centrifuga-
F3088-14.
tion. In some instances, the cell adhesion strength will be
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 Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
the ASTM website. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3088 − 14
greaterthantheappliedforces.Therefore,forcertaincelltypes 5. Interferences
NOTE 1—The following interferences may result in variable and
that have attached for extended periods of time, the method
inconsistentresultsfromthismethodandcar
...

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FDA CFR:  
21 CFR 3: Product Jurisdiction:  
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    
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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