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ASTM E2524-22

(Test Method)

Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

SIGNIFICANCE AND USE
5.1 This test method is one of a series of tests listed in Practice F748 and ISO 10993-4 to assess the biocompatibility of materials contacting blood in medical applications.  
5.2 This test method is similar to Practice F756 but modified to accommodate nanoparticulate materials.
SCOPE
1.1 This test method covers assessing the effect of nanoparticulate materials on the integrity of red blood cells.  
1.2 This test method uses diluted whole blood incubated with nanoparticulate material and the hemoglobin released from damaged red blood cells is determined.  
1.3 This test method is similar to Practice F756 with the volumes reduced to accommodate nanoparticulate material.  
1.4 This test method is part of the in-vitro preclinical characterization and is important for nanoparticulate material that will contact the blood 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
31-Aug-2022
ICS
11.100.01 - Laboratory medicine in general
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.03 - Environment, Health, and Safety
Current Stage
Ref Project

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ASTM E2524-22 - Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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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: E2524 − 22
Standard Test Method for
1
Analysis of Hemolytic Properties of Nanoparticles
This standard is issued under the fixed designation E2524; 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 F1877Practice for Characterization of Particles
F1903Practice for Testing for Cellular Responses to Par-
1.1 This test method covers assessing the effect of nanopar-
ticles in vitro
ticulate materials on the integrity of red blood cells.
3
2.2 ISO Standard:
1.2 This test method uses diluted whole blood incubated
ISO 10993-4Biological Evaluation of Medical Devices Part
with nanoparticulate material and the hemoglobin released
4: Selection of Tests for Interactions with Blood
from damaged red blood cells is determined.
3. Terminology
1.3 This test method is similar to Practice F756 with the
volumes reduced to accommodate nanoparticulate material.
3.1 Acronyms:
3.1.1 Cal—calibration standard
1.4 This test method is part of the in-vitro preclinical
characterization and is important for nanoparticulate material
3.1.2 CMH—cyanmethemoglobin
that will contact the blood in medical applications.
3.1.3 DPBS—Dulbecco’s phosphate-buffered saline
1.5 The values stated in SI units are to be regarded as
3.1.4 PFH—plasma-free hemoglobin
standard. No other units of measurement are included in this
3.1.5 QC—quality controls
standard.
3.1.6 TBH—total blood hemoglobin
1.6 This standard does not purport to address all of the
3.1.7 TBHd—blood sample diluted to 10 mg 6 1 mg/mL
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Summary of Test Method
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
4.1 Thistestmethoddescribesaprotocolforassessingacute
1.7 This international standard was developed in accor-
in-vitro damage to red blood cells (that is, hemolysis) caused
dance with internationally recognized principles on standard-
by exposure to nanoparticles.
ization established in the Decision on Principles for the
4.2 This test method is based on the quantitative determi-
Development of International Standards, Guides and Recom-
nation of hemoglobin released into PFH as a percentage of the
mendations issued by the World Trade Organization Technical
TBH concentration when blood is exposed to nanoparticulate
Barriers to Trade (TBT) Committee.
materials.
4
2. Referenced Documents
4.3 Using an established colorimetric assay, hemoglobin
2
and its derivatives, such as sulfhemoglobin, are oxidized to
2.1 ASTM Standards:
methemoglobin by ferricyanide in the presence of alkali. A
F748PracticeforSelectingGenericBiologicalTestMethods
stable CMH concentration is measured using a plate reader
for Materials and Devices
spectrophotometer set at 540 nm.
F756Practice for Assessment of Hemolytic Properties of
Materials
4.4 Hemoglobin standards are used to create a standard
curvecoveringtherangefrom0.025mg⁄mLto0.8mg/mLand
prepare quality control samples at low (0.0625-mg/mL), mid
1
This test method is under the jurisdiction of ASTM Committee E56 on
(0.125-mg/mL), and high (0.625-mg/mL) concentrations to
Nanotechnology and is the direct responsibility of Subcommittee E56.03 on
Environment, Health, and Safety.
monitor assay performance. The required sample volume is
Current edition approved Sept. 1, 2022. Published October 2022. Originally
100 µL per test replicate.
approved in 2008. Last previous edition approved in 2013 as E2524 – 08(2013),
which was withdrawn in April 2022 and reinstated in September 2022. DOI:
10.1520/E2524-22.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Standards volume information, refer to the standard’s Document Summary page on International Committee for Standardization in Haemotology, Journal of
the ASTM website. Clinical Pathology, Vol 31, 1978, pp. 139–143.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2524 − 22
TABLE 2 Quality Controls
4.5 The results are expressed as percent hemolysis to
evaluate the acute in-vitro hemolytic properties of
...

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Standard Guide for Assessing the Environmental and Human Health Impacts of New Compounds for Military Use

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide a logical, tiered approach in the development of environmental health criteria coincident with level and effort in the research, development, testing, and evaluation of new materials for military use. Various levels of uncertainty are associated with data collected from previous stages. Following the recommendation in the guide should reduce the relative uncertainty of the data collected at each developmental stage. At each stage, a general weight of evidence qualifier shall accompany each exposure/effect relationship. They may be simple (for example, low, medium, or high confidence) or sophisticated using a numerical value for each predictor as a multiplier to ascertain relative confidence in each step of risk characterization. The specific method used will depend on the stage of development, quantity and availability of data, variation in the measurement, and general knowledge of the dataset. Since specific formulations, conditions, and use scenarios may not be known until the later stages, exposure estimates can be determined when practical (for example, Engineering and Manufacturing Development; see 6.6). Exposure data can then be used with other toxicological data collected from previous stages in a quantitative risk assessment to determine the relative degree of hazard.  
5.2 Data developed from the use of this guide are designed to be consistent with criteria required in weapons and weapons system development (for example, programmatic environment, safety and occupational health evaluations, environmental assessments/environmental impact statements, toxicity clearances, and technical data sheets).  
5.3 Information shall be evaluated in a flexible manner consistent with the needs of the authorizing program. This requires proper characterization of the current problem. For example, compounds may be ranked relative to the environmental criteria of the prospective alternatives, the replacement compound, and within bo...
SCOPE
1.1 This guide is intended to determine the relative environmental influence of new substances, consistent with the research and development (R&D) level of effort and is intended to be applied in a logical, tiered manner that parallels both the available funding and the stage of research, development, testing, and evaluation. Specifically, conservative assumptions, relationships, and models are recommended early in the research stage, and as the technology is matured, empirical data will be developed and used. Munition constituents are included and may include propellants, oxidizers, explosives, binders, stabilizers, metals, dyes, and other compounds used in the formulation to produce a desired effect. Munition systems range from projectiles, grenades, rockets/missiles, training simulators, to smokes and obscurants. Given the complexity of issues involved in the assessment of environmental fate and effects and the diversity of the systems used, this guide is broad in scope and not intended to address every factor that may be important in an environmental context. Rather, it is intended to reduce uncertainty at minimal cost by considering the most important factors related to human health and environmental impacts of energetic materials. This guide provides an outline for collecting data useful in a relative ranking procedure to provide the systems scientist with a sound basis for prospectively determining a selection of candidates based on environmental and human health criteria. The general principles in this guide are applicable to substances other than energetics if intended to be used in a similar manner with similar exposure profiles.  
1.2 The scope of this guide includes:  
1.2.1 Energetic and other new/novel materials and compositions in all stages of research, development, test and evaluation.  
1.2.2 Environmental assessment, including:
1.2.2.1 Human and ecological effects of the unexploded energetics and ...

  • Guide
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    English language
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  • Guide
    9 pages
    English language
    sale 15% off