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ASTM E2525-22

(Test Method)

Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

SIGNIFICANCE AND USE
5.1 Stem cells of hematopoietic origin are pluripotential and may be particularly sensitive to the effects of stimulation by nanoparticulate materials.  
5.2 The effect of particles on macrophage responses has an extensive history and can be assessed by Practice F1903. The test method described here will assess the effect on stem cells which can be progenitor cells to the macrophage line.
SCOPE
1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution (isotonic, pH 7.2 ± 0.2) on granulocyte-macrophage colony-forming units (CFU-GM).  
1.2 CFU-GM reflects the number of viable bone marrow cells which differentiate into granulocytes and macrophages. A decrease in CFU-GM count is indicative of a test substance’s toxicity to bone marrow and is commonly used for the identification of drug products with myelosuppressive properties, a form of immunosuppression.  
1.3 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted.  
1.4 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications.  
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.

General Information

Status
Published
Publication Date
30-Jun-2022
ICS
07.100.10 - Medical microbiology
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.03 - Environment, Health, and Safety
Current Stage
Ref Project

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ASTM E2525-22 - Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage ColoniesASTM E2525-22 - Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies
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ASTM E2525-22 - Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies
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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: E2525 − 22
Standard Test Method for
Evaluation of the Effect of Nanoparticulate Materials on the
1
Formation of Mouse Granulocyte-Macrophage Colonies
This standard is issued under the fixed designation E2525; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This test method provides a protocol for quantitative
F1903Practice for Testing for Cellular Responses to Par-
analysis of the effect of nanoparticulate materials in physi-
ticles in vitro
ologic solution (isotonic, pH 7.2 6 0.2) on granulocyte-
3
2.2 ANSI Standard:
macrophage colony-forming units (CFU-GM).
ANSI/ AAMI ST72 Bacterial Endotoxins—Test
1.2 CFU-GM reflects the number of viable bone marrow
Methodologies, Routine Monitoring, and Alternatives to
cellswhichdifferentiateintogranulocytesandmacrophages.A
Batch Testing
decrease in CFU-GM count is indicative of a test substance’s
3. Terminology
toxicity to bone marrow and is commonly used for the
identification of drug products with myelosuppressive
3.1 Abbreviations:
properties, a form of immunosuppression.
3.1.1 CFU-GM—colony forming unit of granulocyte and
macrophage
1.3 This test method employs murine bone marrow he-
3.1.2 DMSO—dimethyl sulfoxide
matopoietic stem cells which proliferate and differentiate to
3.1.3 DPBS—Dulbecco’s phosphate buffered saline
form discrete cell clusters or colonies which are counted.
3.1.4 FBS—fetal bovine serum
1.4 This test method is part of the in vitro preclinical
3.1.5 IMDM—Iscove’s media
characterization cascade for nanoparticulate materials for sys-
temic administration in medical applications. 3.1.6 LPS—ipopolysaccharide
1.5 The values stated in SI units are to be regarded as
4. Summary of Test Method
standard. No other units of measurement are included in this
4.1 The effect of nanoparticulate materials on the formation
standard.
of granulocyte and macrophage colonies is assessed. Bone
1.6 This standard does not purport to address all of the
marrow cells are obtained from mice and cultured in stimula-
safety concerns, if any, associated with its use. It is the tory media. The number of colony forming units following
responsibility of the user of this standard to establish appro- contactwithnanoparticlesiscountedvisuallyandcomparedto
baseline and positive control. This determines if the nanopar-
priate safety, health, and environmental practices and deter-
ticulate material in physiologic solution is stimulatory or
mine the applicability of regulatory limitations prior to use.
inhibitory to bone marrow stem cells. Aseptic procedures are
1.7 This international standard was developed in accor-
necessary.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
5. Significance and Use
Development of International Standards, Guides and Recom-
5.1 Stemcellsofhematopoieticoriginarepluripotentialand
mendations issued by the World Trade Organization Technical
may be particularly sensitive to the effects of stimulation by
Barriers to Trade (TBT) Committee.
nanoparticulate materials.
1 2
This test method is under the jurisdiction of ASTM Committee E56 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Nanotechnology and is the direct responsibility of Subcommittee E56.03 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Environment, Health, and Safety. Standards volume information, refer to the standard’s Document Summary page on
CurrenteditionapprovedJuly1,2022.PublishedJuly2022.Originallyapproved the ASTM website.
3
in 2008. Last previous edition approved in 2013 as E2525 – 08(2013), which was Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
withdrawn in April 2022 and reinstated July 2022. DOI: 10.1520/E2525-22. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2525 − 22
5.2 The effect of particles on macrophage responses has an 6.3.14 Biohazard safety cabinet approved for level II han-
extensive history and can be assessed by Practice F1903. The dling of biological material.
test method described here will assess the effect on stem cells
6.3.15 Inverted microscope.
which can be progenitor cells to the macrophage line.
6.3.16
...

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1.1 The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by the assembly supplier or the end user of the assembly based on a potential risk of a breach to the product or manufacturing process.  
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5.1 In-vitro osteoblast differentiation assays are one approach to screen progenitor stem cells for their capability to become osteoblasts. The extent of calcium deposits or mineralized matrix that form in vitro may be an indicator of differentiation to a functional osteoblast; however, expression of osteogenic genes or proteins is another important measurement to use in conjunction with this assay to determine the presence of an osteoblast.  
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1.1 The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments.  
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4.1 This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices.  
4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered.
Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication.  
4.3 This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.
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Bend  
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Rockwell  
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Keywords  
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Annex A2  
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Standard Practice for Electrofusion Joining Polyethylene (PE) Pipe and Fittings for Pressure Pipe Service

SIGNIFICANCE AND USE
4.1 Using the procedures and apparatus in Sections 8 and 9 and the manufacturer's instructions, pressure-tight joints as strong as the pipe itself can be made between manufacturer-recommended combinations of pipe and fittings. See Specification F1055 for performance requirements of polyethylene electrofusion fittings.
SCOPE
1.1 This practice describes procedures for making joints suitable for pressure service with polyethylene (PE) pipe and fittings by means of electrofusion joining techniques in, but not limited to, a field environment. Other suitable electrofusion joining procedures are available from various sources including fitting manufacturers. This standard does not purport to address all possible electrofusion joining procedures, or to preclude the use of qualified procedures developed by other parties that have been proven to produce reliable electrofusion joints. (Note 1)
Note 1: Reference to the manufacturer in this practice refers to the electrofusion fitting manufacturer.  
1.2 The parameters and procedure are applicable only to joining polyethylene pipe and fittings (Note 2) which are intended for PE fuel gas pipe per Specification D2513 and PE potable water, sewer and industrial pipe manufactured per Specification F714, Specification D3035, Specification F2619, and AWWA C901 and C906.
Note 2: Commercially available materials classified with a thermoplastic pipe material designation code beginning with PE 14, PE 23, PE 24, PE 27, PE 33, PE 34, PE 36, and PE 46, and PE 47 in accordance with Specification D3350 and Terminology F412 are generally acceptable for electrofusion joining using this practice. Consult with the pipe or fitting manufacturer for specific compatibility information.  
1.3 Parts that are within the dimensional tolerances given in present ASTM specifications are required to produce sound joints between polyethylene pipe and fittings when using the joining techniques described in this practice.  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.5 The text of this practice references notes, footnotes, and appendices which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the practice.  
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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ASTM
ASTM D5141-23(Test Method)
Standard Test Method for Determining Filtering Efficiency and Flow Rate of the Filtration Component of a Sediment Retention Device

SIGNIFICANCE AND USE
5.1 This test method is used to determine the filtering efficiency and flow rate of the filtration component of a sediment retention device, such as a silt fence, a silt barrier, or a silt curtain, for specific soil tested.  
5.2 This test method may be used for the design of the filtration component of a sediment retention device to meet requirements of regulatory agencies in filtering efficiency or flow rate for the specific soil tested.  
5.2.1 The designer can use this test method to determine the spacing between sediment retention devices.  
5.3 This test method is intended for performance evaluation, as the results will depend on the specific soil evaluated. Unless testing with the default soil is desired, it is recommended that the user or representative perform the test to pre-approve products, as sediment retention device manufacturers are not typically equipped to handle or test soil requirements.  
5.4 This test method provides a means of evaluating the filtration component of sediment retention devices with different soils under various conditions that simulate the conditions that exist in a sediment retention device installation. This test method may be used to simulate several storm events on the same sediment retention device specimen. Therefore, the number of times this test is repeated per specimen is dependent upon the user and the site conditions.
SCOPE
1.1 This test method is used to determine the filtering efficiency and the flow rate of the filtration component of a sediment retention device, such as a silt fence, silt barrier, or inlet protector.  
1.1.1 The results are shown as a percentage for filtering efficiency and cubic metres per square metre per minute (m3/m2/min) or gallons per square foot per minute (gal/ft2/min) for flow rate.  
1.1.2 The filtering efficiency indicates the percent of sediment removed from sediment-laden water.  
1.1.3 The flow rate is the average rate of passage of the sediment-laden water through the filtration component of a sediment retention device.  
1.2 This test method requires several specialized pieces of equipment, such as an integrated water sampler and an analytical balance, or a vacuum filtration system. At the client’s discretion, the test soil is either a site-specific soil or a soil that is representative of a target default gradation.  
1.3 The values stated in SI units are the standard, while the inch-pound units are provided for information. The values expressed in each system may not be exact equivalents; therefore, each system must be used independently of the other, without combining values in any way.  
1.4 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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  • Standard
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    English language
    sale 15% off