ASTM F1862/F1862M-24
(Test Method)Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.
5.2 Medical face masks may be intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.6 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 40 ± 5 dyn/cm (0.040 ± 0.005 N/m).
5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.
5.4 During a medical procedure, a blood vessel is occasionally punctured, resulting in a high-velocity stream of blood impacting a protective medical face mask. The impact velocity depends...
SCOPE
1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method is primarily intended to address the performance of finished medical face masks. While this test method may also be used to assess performance of materials or certain material constructions used in medical face masks, it is important to note the performance of finished medical face masks may be impacted by the interaction of the materials used and how they have been assembled. Results can differ depending on testing a final finished medical face mask or materials taken from manufactured medical face masks.
1.4 This test method does not address other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop).
1.5 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
1.6 The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of...
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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: F1862/F1862M − 24
Standard Test Method for
Resistance of Medical Face Masks to Penetration by
Synthetic Blood (Horizontal Projection of Fixed Volume at a
1
Known Velocity)
This standard is issued under the fixed designation F1862/F1862M; 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.
INTRODUCTION
Workers, primarily those in the healthcare profession involved in treating and caring for individuals
injured or sick, can be exposed to biological liquids capable of transmitting disease. These diseases,
which may be caused by a variety of microorganisms, can pose significant risks to life and health. This
is especially true of blood-borne viruses which cause hepatitis (hepatitis B virus (HBV) and hepatitis
C virus (HCV)) and acquired immune deficiency syndrome (AIDS) (human immunodeficiency virus
(HIV)). Because engineering controls cannot eliminate all possible exposures, attention is placed on
reducing the potential of direct skin and mucous membrane contact through the use of protective
clothing that resists penetration (29 CFR Part 1910.1030). This test method was developed for
assessing the synthetic blood penetration resistance performance of medical face masks in a manner
representing actual use as might occur when a high-velocity stream of blood from a punctured artery
hits the face mask.
1. Scope 1.4 This test method does not address other factors with the
potential to affect the overall protection offered by the medical
1.1 This test method is used to evaluate the resistance of
face mask and its operation (such as filtration efficiency and
medical face masks to penetration by the impact of a small
pressure drop).
volume (~2 mL) of a high-velocity stream of synthetic blood.
Medical face mask pass/fail determinations are based on visual
1.5 This test method does not address breathability of the
detection of synthetic blood penetration.
medical face mask materials or any other properties affecting
the ease of breathing through the medical face mask. This test
1.2 This test method does not apply to all forms or condi-
method evaluates medical face masks as an item of protective
tions of blood-borne pathogen exposure. Users of the test
clothing. This test method does not evaluate the performance
method must review modes for face exposure and assess the
of medical face masks for airborne exposure pathways or in the
appropriateness of this test method for their specific applica-
prevention of the penetration of aerosolized body fluids depos-
tion.
ited on the medical face mask.
1.3 This test method is primarily intended to address the
performance of finished medical face masks. While this test
1.6 The values stated in SI units or inch-pound units are to
method may also be used to assess performance of materials or
be regarded separately as standard. The values stated in each
certain material constructions used in medical face masks, it is
system may not be exact equivalents; therefore, each system
important to note the performance of finished medical face
shall be used independently of the other. Combining values
masks may be impacted by the interaction of the materials used
from the two systems may result in nonconformance with the
and how they have been assembled. Results can differ depend-
standard. The pressure values stated in each system are not
ing on testing a final finished medical face mask or materials
exact equivalents. However, as the corresponding velocities are
taken from manufactured medical face masks.
within 1 % of each other (see X1.4.2), reporting of the results
in either units is permitted.
1
1.7 This standard does not purport to address all of the
This test method is under the jurisdiction of ASTM Committee F23 on Personal
Protective Clothing and Equipment and is the direct responsibility of Subcommittee
safety concerns, if any, associated with its use. It is the
F23.40 on Biological.
responsibility of the user of this standard to establish appro-
Current edition approved Feb. 1, 2024. Published March 2024. Originally
priate safety, health, and environmental practices and deter-
approved in 1998. Last previous edition approved in 2017 as F1862/F1862M – 17.
DOI: 10.1520/F1862_F1862M-24. mine the applicability of regulatory limitations prior to use.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F
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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1862/F1862M − 17 F1862/F1862M − 24
Standard Test Method for
Resistance of Medical Face Masks to Penetration by
Synthetic Blood (Horizontal Projection of Fixed Volume at a
1
Known Velocity)
This standard is issued under the fixed designation F1862/F1862M; 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.
INTRODUCTION
Workers, primarily those in the healthcare profession,profession involved in treating and caring for
individuals injured or sick, can be exposed to biological liquids capable of transmitting disease. These
diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and
health. This is especially true of blood-borne viruses which cause hepatitis (hepatitis B virus (HBV)
and hepatitis C virus (HCV)) and acquired immune deficiency syndrome (AIDS) (human immuno-
deficiency virus (HIV)). Because engineering controls can not cannot eliminate all possible exposures,
attention is placed on reducing the potential of direct skin and mucous membrane contact through the
use of protective clothing that resists penetration (29 CFR Part 1910.1030). This test method was
developed for rankingassessing the synthetic blood penetration resistance performance of medical
aceface masks in a manner representing actual use as might occur when the face mask is contacted by
a high-velocity stream of blood from a punctured wound.artery hits the face mask.
1. Scope
1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2
mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of
synthetic blood penetration.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must
review modes for face exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method is primarily intended to address the performance of finished medical face masks. While this test method may
also be used to assess performance of materials or certain material constructions used in medical face masks, it is important to note
the performance of finished medical face masks may be impacted by the interaction of the materials used and how they have been
assembled. Results can differ depending on testing a final finished medical face mask or materials taken from manufactured
medical face masks.
1.4 This test method primarily addresses the performance of materials or certain material constructions used in medical face
masks. This test method does not address the performance of the medical face mask’s design, construction, or interfaces or other
1
This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological.
Current edition approved June 1, 2017Feb. 1, 2024. Published June 2017March 2024. Originally approved in 1998. Last previous edition approved in 20132017 as
F1862/F1862M – 13.F1862/F1862M – 17. DOI: 10.1520/F1862_F1862M-17.10.1520/F1862_F1862M-24.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1862/F1862M − 24
factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration
efficiency and pressure drop). Procedures for measuring these properties are contained in Test Method F2101 and MIL-M-36954C.
1.5 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease
of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This
test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the
penetration of aerosolized body fluids deposited on the medical face mask.
1.6 The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system
may not be exact equivalents; therefore, each system shall be used independently of the other. Combining va
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