ASTM F1862/F1862M-24

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...

General Information

• Status: Published
• Publication Date: 31-Jan-2024
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaces: ASTM F1862/F1862M-17 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• Effective Date: 01-Feb-2024
• Refers: ASTM F1670/F1670M-24 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 01-Feb-2024
• Refers: ASTM F1670/F1670M-17a - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
• Effective Date: 25-Oct-2017

Overview

ASTM F1862/F1862M-24 establishes a standardized test method for evaluating the resistance of medical face masks to penetration by synthetic blood under high velocity, simulating arterial blood splatter. Developed by ASTM International, this method is essential for healthcare environments where exposure to blood and potentially infectious fluids may occur. The test helps manufacturers, quality assurance teams, and healthcare providers determine the penetration resistance performance of finished medical face masks and relevant materials, supporting product claims and regulatory compliance.

Key Topics

• Purpose of the Standard: Defines a procedure for assessing how medical face masks withstand synthetic blood impacts, providing an objective basis for product comparison and quality control.
• Test Methodology:
  • Masks are exposed to a horizontal stream of synthetic blood at controlled velocities and volumes to simulate real medical scenarios.
  • Results are visually assessed for penetration on the inner mask surface; pass/fail status is determined accordingly.
• Application Scope:
  • Primarily applies to finished medical face masks, though it can be used for specific materials or construction methods.
• Limitations:
  • The method does not cover all possible exposure scenarios or performance characteristics such as filtration efficiency or breathability.
  • It is designed for liquid penetration resistance, not for evaluation against airborne pathogens or aerosolized fluids.
• Synthetic Blood Properties: The test fluid matches the surface tension and flow properties of blood, aiding in realistic simulation while remaining distinguishable through color additives.

Applications

• Healthcare Settings: Assists in selecting appropriate medical face masks for use in hospitals, clinics, dental offices, and laboratories where protection from blood and body fluid splashes is critical.
• Manufacturing and Product Development: Enables mask manufacturers to validate and promote claims of fluid resistance, aiding in product differentiation and compliance with global regulatory requirements.
• Quality Control and Procurement: Allows purchasers, quality inspectors, and regulatory authorities to verify that medical face masks meet specified performance thresholds for synthetic blood penetration.
• Sampling and Statistical Analysis: Supports organizations in implementing statistically sound sampling and acceptance plans (as referenced by ISO 2859-1 and ANSI/ASQC Z1.4), helping manage batch quality and consistency.
• Risk Management: Facilitates healthcare risk assessments to minimize the threat of contact with blood-borne pathogens such as HIV, HBV, and HCV by identifying masks with adequate penetration resistance.

Related Standards

• ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F2101: Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials
• ASTM F1670/F1670M: Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood (different methodology, continuous rather than projected stream)
• ASTM F1671/F1671M: Test Method for Resistance of Materials to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage
• ISO 2859-1: Sampling Procedures for Inspection by Attributes
• ANSI/ASQC Z1.4: Sampling Procedures and Tables for Inspection by Attributes

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By standardizing how medical face masks are evaluated for resistance to synthetic blood penetration, ASTM F1862/F1862M-24 ensures greater safety for healthcare professionals and supports the quality and reliability of personal protective equipment worldwide. This test method is a crucial reference in product design, quality assurance, and procurement practices for protective medical face masks.

Standards Content (Sample)

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
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.
1.7 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
F1862/F1862M − 24
1.8 This international standard was developed in accor- 3.1.1 aerosolized body fluids, n—body fluids that have been
dance with internationally recognized principles on standard- dispersed into air as very small liquid droplets.
ization established in the Decision on Principles for the
3.1.2 airborne exposure pathways, n—inhalation routes of
Development of International Standards, Guides and Recom-
exposure to the medical face mask wearer.
mendations issued by the World Trade Organization Technical
3.1.3 blood-borne pathogen, n—an infectious bacterium or
Barriers to Trade (TBT) Committee.
virus, or other disease-inducing microbe carried in blood or
other potentially infectious body fluids.
2. Referenced Documents
3.1.4 body fluid, n—any liquid produced, secreted, or ex-
2.1 ASTM Standards:
creted by the human body.
D891 Test Methods for Specific Gravity, Apparent, of Liquid
3.1.4.1 Discussion—In this test method, body fluids include
Industrial Chemicals
liquids potentially infected with blood-borne pathogens,
D1331 Test Methods for Surface and Interfacial Tension of
including, but not limited to, blood, semen, vaginal secretions,
Solutions of Paints, Solvents, Solutions of Surface-Active
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
Agents, and Related Materials
otic fluid, saliva in dental procedures, and any body fluid that
E171/E171M Practice for Conditioning and Testing Flexible
is visibly contaminated with blood, and all body fluids in
Barrier Packaging
situations where it is difficult or impossible to differentiate
F1494 Terminology Relating to Protective Clothing
between body fluids (see 29 CFR Part 1910.1030).
F1670/F1670M Test Method for Resistance of Materials
3.1.5 body fluid simulant, n—a liquid that is used to act as a
Used in Protective Clothing to Penetration by Synthetic
model for human body fluids.
Blood
3.1.6 medical face mask, n—an item of protective clothing
F1671/F1671M Test Method for Resistance of Materials
designed to protect portions of the wearer’s face, including the
Used in Protective Clothing to Penetration by Blood-
mucous membrane areas of the wearer’s nose and mouth, from
Borne Pathogens Using Phi-X174 Bacteriophage Penetra-
contact with blood and other body fluids during medical
tion as a Test System
procedures.
F2100 Specification for Performance of Materials Used in
Medical Face Masks
3.1.7 penetration, n—for biological protective clothing, the
2.2 ANSI/ASQC Standards:
flow of a body fluid on a non-molecular level through closures,
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In- porous materials, seams, and pinholes, or other imperfections
spection by Attributes
in protective clothing.
ANSI/ASQC Q3 Sampling Procedures and Tables for In- 3.1.7.1 Discussion—In this test method, the penetration
spection of Isolated Lots by Attributes
liquid is synthetic blood, a body fluid simulant.
2.3 ISO Standards:
3.1.8 protective clothing, n—an item of clothing that is
ISO 28590 Sampling Procedures for Inspection by
specifically designed and constructed for the intended purpose
Attributes—Introduction to the ISO 2859 Series of Stan-
of isolating all or part of the body from a potential hazard; or,
dards for Sampling for Inspection by Attributes
isolating the external environment from contamination by the
ISO 2859-1 Sampling Plans for Inspection by Attributes
wearer of the clothing.
ISO/TR 8550-1 Guidance on the Selection and Usage of
3.1.8.1 Discussion—In this test method, medical face masks
Acceptance Sampling Systems for Inspection of Discrete
are evaluated. The potential hazard of contact with blood or
Items in Lots—Part 1: Acceptance Sampling
other body fluids is being simulated.
ISO/TR 8550-2 Guidance on the Selection and Usage of
3.1.9 spurt, n—a short duration gush or volume of fluid.
Acceptance Sampling Systems for Inspection of Discrete
3.1.9.1 Discussion—In this test method, a spurt refers to the
Items in Lots—Part 2: Sampling by Attributes
volume of fluid disbursed from the apparatus at the sample
2.4 OSHA Standard:
mask. It can also refer to the volume of fluid ejected from a
29 CFR Part 1910.1030 Occupational Exposure to Blood-
punctured blood vessel.
borne Pathogens: Final Rule, Federal Register, Vol 56, No
3.1.10 synthetic blood, n—a mixture of a red dye/surfactant,
235, Dec. 6, 1991, pp. 64175–64182
thickening agent, and distilled water having a surface tension
and viscosity representative of blood and some other body
3. Terminology
fluids, and the color of blood.
3.1 Definitions:
3.1.10.1 Discussion—The synthetic blood in this test
method does not simulate all of the characteristics of blood or
For referenced ASTM standards, visit the ASTM website, www.astm.org, or body fluids, for example, polarity (wetting characteristics),
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
coagulation, and content of cell matter.
Standards volume information, refer to the standard’s Document Summary page on
3.1.11 For definitions of other protective clothing-related
the ASTM website.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
terms used in this test method, refer to Terminology F1494.
Milwaukee, WI 53203.
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4. Summary of Test Method
4th Floor, New York, NY 10036.
4.1 A volume of synthetic blood is disbursed at a specimen
Available from Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. mask from a set distance to simulate the impact (splatter) of
F1862/F1862M − 24
blood or other body fluid onto the specimen. The velocity and is based on the assumption that the medical face mask will be
volume of fluid are set to simulate a given healthcare scenario. in close proximity (within 300 mm or 12 in.) to the puncture
area. The use of this test method is, therefore, based on
4.2 Any evidence of synthetic blood penetration on the
selecting an appropriate blood pressure, finding the corre-
inner facing of the medical face mask (side contacting the
sponding stream or impact velocity, and determining the valve
wearer’s face) constitutes a failure. Results are reported as
time to create that stream velocity as shown in Appendix X1.
pass/fail.
5.4.1 The mean human blood pressure generally varies over
4.3 Specimen medical face masks are evaluated at velocities
a range of about 10.7 to 16.0 kPa (80 to 120 mmHg). In this
of 450, 500, or 635 cm/s. These correspond to the velocity
test method, medical face masks are tested at stream velocities
exiting a small arterial puncture at human blood pressures of
corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg,
10.7, 16.0, or 21.3 kPa (80, 120, or 160 mmHg). Results are
120 mmHg, and 160 mmHg).
reported for each velocity or corresponding pressure tested.
5.5 This test method permits the use of other non-standard
test pressures, stream velocities, fluid volumes, and specimen
5. Significance and Use
orientations for evaluating medical face mask penetration
5.1 This test method offers a procedure for evaluating
resistance consistent with specific applications.
medical face mask resistance to synthetic blood penetration
5.6 This test method differs from Test Method F1670/
that is useful in establishing claims for penetration resistance
F1670M by dispensing a stream of 2 mL of synthetic blood
performance of medical face masks and ranking their perfor-
against the target area of a complete medical mask specimen,
mance. However, this test method does not define acceptable
whereas Test Method F1670/F1670M involves the continuous
levels of penetration resistance because this determination
contact of a specimen of protective clothing with synthetic
must be made by each responsible user organization based on
blood over the period of an hour. One minute of the exposure
its own specific application and conditions. Therefore, when
in Test Method F1670/F1670M is at hydrostatic pressure of
using this test method to make claims for the performance of
13.8 kPa [2.0 psig]. Test Method F1670/F1670M is used for
medical face masks, the specific conditions under which testing
preliminary evaluation of protective clothing penetration resis-
is conducted must be described.
tance to synthetic blood in conjunction with Test Method
5.2 Medical face masks may be intended to resist liquid
F1671/F1671M that uses a microbiological challenge. Both
penetration from the splatter or splashing of blood, body fluids,
procedures are intended for assessment of protective clothing
and other potentially infectious materials. Many factors affect
which has the potential to contact blood or other body fluids for
the wetting and penetration characteristics of body fluids, such
extended periods of time, and under pressure.
as surface tension, viscosity, and polarity of the fluid, as well as
5.7 Users of this test method must realize that certain
the structure and relative hydrophilicity or hydrophobicity of
the materials and the design of the mask itself. The surface tradeoffs exist between improved resistance of medical face
masks to penetration by synthetic blood and in pressure drop
tension range for blood and body fluids (excluding saliva) is
approximately 0.042 to 0.060 N/m. To help simulate the across mask materials as an indicator of medical face mask
breathability. In general, increasing synthetic blood penetration
wetting characteristics of blood and body fluids, the surface
resistance for medical face masks results in increasing pressure
tension of the synthetic blood is adjusted to approximate the
drop or reduced breathability for medical face masks of the
lower end of this surface tension range. The resulting surface
same design and fit of the individual wearer.
tension of the synthetic blood is 40 6 5 dyn/cm (0.040 6 0.005
N/m).
5.8 This test method evaluates medical face masks as an
item of protective clothing and does not evaluate medical face
5.3 The synthetic blood mixture is prepared with a red dye
masks as respirators. If respiratory protection for the wearer is
to aid in visual detection and a thickening agent to simulate the
needed, a NIOSH-certified respirator must be used. This test
flow characteristics of blood. The synthetic blood will not
method is useful to evaluate the resistance of a respirator to
always duplicate the polarity, and thus the wetting behavior
penetration by synthetic blood, if warranted.
and subsequent penetration, of real blood and other body fluids
through protective clothing materials.
5.9 This test method involves the preconditioning of speci-
men medical face masks in a relatively high humidity environ-
5.4 During a medical procedure, a blood vessel is occasion-
ment (85 6 5 % relative humidity at 21 6 5 °C [70 6 10 °F])
ally punctured, resulting in a high-velocity stream of blood
to simulate the conditions of use when the wearer creates high
impacting a protective medical face mask. The impact velocity
depends on several factors, the most important being the blood humidity conditions by breathing through the mask. This
preconditioning does not account for saturation of the interior
pressure of the patient. Other factors include the size of the
puncture and distance from the puncture. Because the pressure, medical face mask layer. However, additional pretreatment
techniques in conjunction with this test method as described in
and thus velocity drops quickly with large punctures, large
punctures were not used to model the range of blood splatter 5.10 are permitted. Professional healthcare providers recom-
mend that medical face masks be replaced when saturation
velocities considered in this test. Furthermore, this test method
occurs from breathing or from contact with other liquids.
Lentner, C., ed., Geigy Scientific Tables, Vol 1 – Units of Measurement, Body
Fluids, Composition of Blood, Hematology, Somatometric Data, Medical Education Barach, P. G., Cullen, B. F., and Stoelting, R. K., Handbook on Clinical
Div., Ciba-Geigy Corp., West Caldwell, NJ, 1984. Anesthesia, Appendix A, J. B. Lippincott Co., Philadelphia, 1994.
F1862/F1862M − 24
5.10 Testing prior to degradation by physical, chemical, and purchaser and the supplier must agree to interpret future test
thermal stresses which could negatively impact the perfor- results with consideration to the known bias.
mance of the protective barrier could lead to a false sense of
security. Consider tests which assess the impact of storage 6. Apparatus
conditions and shelf life for disposable products, and the
6.1 Test Apparatus, to dispense a specified volume of
effects of laundering and sterilization for reusable products.
synthetic blood through a small diameter nozzle over a
The integrity of the protective clothing is occasionally com-
controlled amount of time at a specimen mask a set distance
promised during use by such effects as flexing and abrasion. It
away. The test apparatus consists of a specimen holding fixture,
is also possible that pre-wetting by contaminants such as
a targeting plate, a pressurized fluid reservoir, a valve, delivery
alcohol and perspiration also compromises the integrity of the
nozzle, and a valve controller. A permitted optional design for
protective clothing. If these conditions are of concern, evaluate
the test apparatus includes a base for more convenient mount-
the performance of protective clothing for synthetic blood
ing of the components and a hood or other components to
penetration following an appropriate pretreatment technique
contain or control the splash. A photograph of a typical sample
representative of the expected conditions of use.
test apparatus is provided in Fig. 1(a). Fig. 1(b) provides an
5.11 While this test method involves a qualitative determi- example of an alternative apparatus with the addition of a
nation of the medical face mask resistance to penetration by
funnel to collect excess liquid so that the level in the reservoir
synthetic blood under specific test conditions, it is possible to can be estimated to help prevent running out of synthetic blood
use this test method as a quality control or assurance proce-
in the middle of a test lot. Fig. 1(c) and Fig. 1(d) show the
dure. incorporation of X-Y-Z axis slides for easy, smooth fine-tuning
of the nozzle position and also helps keep the pneumatic valve
5.12 If this procedure is used for quality control, perform
steady to reduce the risk of accidentally bumping it out of
proper statistical design and analysis of larger data sets to
adjustment. Other specifications for the specimen holding
determine the required number of specimens to be tested.
fixture include as follows:
Sampling conducted in this way helps to establish confidence
6.1.1 Specimen Holding Fixture, to support the specimen
limits concerning product performance. The sampling plan or
mask during the test. The design and construction of the
statistical approach selected should be designated or approved
specimen holding fixture has a significant impact on the
by the relevant responsible authority. Examples of acceptable
outcome of the test. The specimen holder and supporting frame
sampling plans are found in references such as the ISO 2859
must be sufficiently stiff and rigid that the energy of the impact
series of standards for inspection by attributes and ANSI/
of the spurt is absorbed solely by the specimen mask. The
ASQC Z1.4 and ANSI/ASQC Q3.
specimen holder and frame must not deform, flex, or bend
NOTE 1—Guidance on the selection of acceptance sampling plans can
during a test. If necessary, alter the fixture design details from
be found in references such as ISO/TR 8550-1 and ISO/TR 8550-2.
that described below, in order to provide appropriate specimen
NOTE 2—Subject to the purpose of testing the relevant responsible
presentation while maintaining the intent of the method de-
authority may be a first, second, or third party. Further information about
scribed herein.
responsible authorities in the context of acceptance sampling plans
(including examples, duties, and functions) can be found in references
6.1.1.1 The standard backing form for the specimen holder
such as ISO 2859-1.
is a solid section of a 12.7 cm [5 in.] diameter sphere. Use a
5.13 In the case of a dispute arising from differences in
form made of a material with a Shore A hardness of at least 40.
reported results when using this test method for acceptance (See Note 3.) The form has a 5.7 cm [2.25 in.] diameter
testing of commercial shipments, conduct comparative tests
viewing hole through its center as shown in Figs. 2 and 3.
between the purchaser and supplier to determine if there is a
NOTE 3—A backing form can be made from liquid polyester resin
statistical bias between their laboratories. Competent statistical
(found at home improvement centers or auto parts stores), a 5 in. ball
assistance is recommended for investigation of bias. At
candle mold (candle supply companies), and a 2 in. PVC tubing union
minimum, take a group of test specimens which are as (5.7 cm [2.25 in.] outside diameter, found at home improvement centers).
Mark a ring around the outside of the union 3.0 cm [1 ⁄8 in.] from one end.
homogeneous as possible and which are from a lot of the
This will indicate the proper depth to fill the form to fit the apparatus
product of the type in question. Randomly assign test speci-
described in this method. The depth can be adjusted to accommodate
mens in equal numbers to each laboratory for testing. Compare
variations in the design of the specimen mask holder. The key element is
the average results from the two laboratories using a non-
to maintain the diameter of the form at the plane of the cuff at 10.5 cm
[4.125 in.]. Using plumber’s putty on the end of the union opposite the
parametric test for unpaired data and an acceptable probability
depth mark, seal the union to the inside of one half of the ball mold. Set
level chosen by the two parties before testing is begun. If a bias
the mold in the mold stand. Rest a level on the union to ensure the hold
is found, either its cause must be found and corrected or the
is horizontal in all directions. Mix about 355 mL [12 fl oz] of resin and 25
drops of hardener in a well-ventilated area. Carefully pour the resin into
the mold outside of the union, making an annular form. Fill the mold up
to the line on the union, taking into account the meniscus of the fluid.
Telford, G. L. and Quebbeman, E. J., “Assessing the Risk of Blood Exposure
in the Operating Room,” American Journal of Infection Control, Vol 21, No. 6, Once hardened, remove the form from the mold and the union from the
December 1993, pp. 351–356. mold. The use of a short piece of 2 in. PVC tubing is suitable to carefully
F1862/F1862M − 24
S = Specimen Holder T = Targeting Plate with Collection Cups
R = Pressurized Fluid Reservoir N = Nozzle
V = Valve VC = Valve Timing Controller
VS = Valve Switch
FIG. 1 (a) Test Apparatus
knock the union out of the mold. Sand the base of the mold such that the
1.27 cm [ ⁄2 in.] in front of the specimen mask, between the
surface is flush. Drill and tap mounting holes into the mold.
mask and the nozzle, such that the stream impacts the center of
6.1.1.2 The backing form is mounted to a plate which is
hole in the mask supporting form.
hinged to the specimen holder frame so there is a 0.6 cm
6.1.2.1 A suitable method for containing the splatter of fluid
[0.25 in.] gap between the plate and the frame, as in Fig. 2. The
hitting the targeting plate uses a disposable plastic cup with a
frame contains an 11.75 cm [4 ⁄8 in.] hole to receive the 3
hole larger than 0.48 cm [ ⁄16 in.] diameter cut out of the
backing form.
bottom. The cup is mounted horizontally with the opening
6.1.1.3 A rubber cuff which partially covers the hole is
facing the nozzle by any convenient method. The run-off is
secured to the frame. The cuff draws the specimen mask across
suitably collected by a second cup placed below the lip of
the backing form. Use a cuff made from 0.08 cm [ ⁄32 in.]
targeting cup, as shown in Fig. 1.
buna-N gasket material with a Shore A hardness of 70. The
6.1.3 Pneumatically Actuated Valve, shall be mounted on
dimensions of the six-point star-shaped opening in the cuff are
a stiff support, such as a ring stand. The valve support shall not
detailed in Fig. 4.
flex when the valve is actuated. The valve shall be positioned
6.1.2 Targeting Plate, to block the high-velocity leading
so that the exit of the nozzle is 30.5 cm [12.0 in.] from the point
edge of the fluid stream and to provide a means of ensuring the
of impact on the specimen mask.
fluid stream hits the target area of the specimen mask. The plate
3 6.1.3.1 Valve Maintenance—Periodically disassemble and
contains a 0.48 cm [ ⁄16 in.] diameter hole. Ensure that the
clean the pneumatically actuated valve with isopropanol to
thickness of the targeting plate at the hole does not exceed
prevent interference with the valve mechanism or plugging of
0.48 cm [ ⁄16 in.] beyond the hole and is made of clear plastic.
the nozzle, which can lead to inconsistent valve performance.
The plate is configured upright and placed approximately
A continuous plastic hinge provides a little more give than a rigid piano hinge.
Reference McMaster Carr 11195A41. McMaster-Carr Supply Company, Atlanta, Reference McMaster-Carr 3427A57 – ⁄16 in. Arch Punch for making the
Georgia. targeting plate holes in soft materials. McMaster-Carr Supply Company, Atlanta,
Reference McMaster-Carr item 8635K161 – 12 in. by 12 in. sheets of 70A Georgia.
hardness ⁄32 in. thick Buna-N gasket material. McMaster-Carr Supply Company, Reference NORDSON EFD LLC, 725D pneumatic fluid dispensing valve or
Atlanta, Georgia. equivalent. NORDSON EFD LLC, 40 Catamore Blvd. East Providence, RI 02914.
F1862/F1862M − 24
FIG. 1 (b) Test Apparatus (continued)
6.1.4 Valve Controller, to set the duration of the fluid 6.2 Air Pressure Source, capable of providing air at a gauge
spurt. Use a valve controller with a resolution and accuracy of pressure recommended by manufacturer of valve controller.
at least 0.01 6 0.005 s.
6.3 Balance, calibrated to measure weight with a precision
6.1.5 Nozzle, which attaches to the exit of the valve for 16
of at least 0.01 g.
delivering the spurt. The standard for this method is a 1.27 cm
6.4 Beaker or Cup, to collect the synthetic blood discharged
[0.5 in.] long, 18 gauge stainless steel cylindrical tube cannula
from the nozzle.
with an internal diameter of 0.084 cm [0.033 in.].
6.1.5.1 Deviations from the standard nozzle must be noted 6.5 Temperature/Humidity Recorder, to monitor ambient
in the test report. conditions during testing.
6.1.6 Pressure-Regulated Fluid Reservoir, to contain the
6.6 Controlled Temperature and Humidity Chamber or
synthetic blood for delivery to the valve/nozzle assembly.
Space, capable of achieving and maintaining specified tem-
perature and humidity conditions.
Reference NORDSON EFD LLC, 1500D controller or equivalent. A remote
7. Reagents
hand or foot actuated switch can also be used with the 1500D controller. NORDSON
EFD LLC, 40 Catamore Blvd. East Providence, RI 02914.
7.1 Synthetic Blood —If synthetic blood is not purchased,
Reference NORDSON EFD LLC, Part Number 5118-B. NORDSON EFD
prepare using the following ingredients:
LLC, 40 Catamore Blvd. East Providence, RI 02914.
Reference NORDSON EFD LLC, parts: 615DTH fluid reservoir; 615DRL
fluid reservoir cover and liner; 61520 reservoir stand; 2000f755 air filter and Weighing the fluid output is faster and more accurate than measuring the fluid
regulator; 1116 air tree. NORDSON EFD LLC, 40 Catamore Blvd. East Providence, volume.
RI 02914. Acrysol G111 is available from Dow Chemical Company.
F1862/F1
...

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
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
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
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 values from the two
systems may result in nonconformance with the standard. The pressure values stated in each system are not exact equivalents.
However, as the corresponding velocities are within 1 % of each other,other (see X1.4.2), reporting of the results in either units
is permitted.
1.7 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.8 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.
2. Referenced Documents
2.1 ASTM Standards:
D891 Test Methods for Specific Gravity, Apparent, of Liquid Industrial Chemicals
D1331 Test Methods for Surface and Interfacial Tension of Solutions of Paints, Solvents, Solutions of Surface-Active Agents,
and Related Materials
E105 Guide for Probability Sampling of Materials
E171/E171M Practice for Conditioning and Testing Flexible Barrier Packaging
F1494 Terminology Relating to Protective Clothing
F1670/F1670M Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
F1671/F1671M Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens
Using Phi-X174 Bacteriophage Penetration as a Test System
F2101F2100 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a
Biological Aerosol of Specification for Performance of Materials Used in Medical Face MasksStaphylococcus aureus
2.2 ANSI/ASQC Standard:Standards:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
ANSI/ASQC Q3 Sampling Procedures and Tables for Inspection of Isolated Lots by Attributes
2.3 ISO Standard:Standards:
ISO 28590 Sampling Procedures for Inspection by Attributes—Introduction to the ISO 2859 Series of Standards for Sampling
for Inspection by Attributes
ISO 2859-1 Sampling Plans for Inspection by Attributes
ISO/TR 8550-1 Guidance on the Selection and Usage of Acceptance Sampling Systems for Inspection of Discrete Items in
Lots—Part 1: Acceptance Sampling
ISO/TR 8550-2 Guidance on the Selection and Usage of Acceptance Sampling Systems for Inspection of Discrete Items in
Lots—Part 2: Sampling by Attributes
2.4 Military Standards:
MIL-M-36954C Military Specification, Mask, Surgical, Disposable
2.4 OSHA Standard:
29 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol 56, No 235, Dec.
6, 1991, pp. 64175–64182
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
Available from Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
F1862/F1862M − 24
3. Terminology
3.1 Definitions:
3.1.1 aerosolized body fluids, n—body fluids that have been dispersed into air as very small liquid droplets.
3.1.2 airborne exposure pathways, n—inhalation routes of exposure to the medical face mask wearer.
3.1.3 blood-borne pathogen, n—an infectious bacterium or virus, or other disease-inducing microbe carried in blood or other
potentially infectious body fluids.
3.1.4 body fluid, n—any liquid produced, secreted, or excreted by the human body.
3.1.4.1 Discussion—
In this test method, body fluids include liquids potentially infected with blood-borne pathogens, including, but not limited to, blood,
semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in dental procedures, and
any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to
differentiate between body fluids (see 29 CFR Part 1910.1030).
3.1.5 body fluid simulant, n—a liquid that is used to act as a model for human body fluids.
3.1.6 medical face mask, n—an item of protective clothing designed to protect portions of the wearer’s face, including the mucous
membrane areas of the wearer’s nose and mouth, from contact with blood and other body fluids during medical procedures.
3.1.7 penetration, n—for biological protective clothing, the flow of a body fluid on a non-molecular level through closures, porous
materials, seams, and pinholes, or other imperfections in protective clothing.
3.1.7.1 Discussion—
In this test method, the penetration liquid is synthetic blood, a body fluid simulant.
3.1.8 protective clothing, n—an item of clothing that is specifically designed and constructed for the intended purpose of isolating
all or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearer of the
clothing.
3.1.8.1 Discussion—
In this test method, medical face masks are evaluated. The potential hazard of contact with blood or other body fluids is being
simulated.
3.1.9 spurt, n—a short duration gush or volume of fluid.
3.1.9.1 Discussion—
In this test method, a spurt refers to the volume of fluid disbursed from the apparatus at the sample mask. It can also refer to the
volume of fluid ejected from a punctured blood vessel.
3.1.10 synthetic blood, n—a mixture of a red dye/surfactant, thickening agent, and distilled water having a surface tension and
viscosity representative of blood and some other body fluids, and the color of blood.
3.1.10.1 Discussion—
The synthetic blood in this test method does not simulate all of the characteristics of blood or body fluids, for example, polarity
(wetting characteristics), coagulation, and content of cell matter.
3.1.11 For definitions of other protective clothing-related terms used in this test method, refer to Terminology F1494.
4. Summary of Test Method
4.1 A volume of synthetic blood is disbursed at a specimen mask by a pneumatically controlled valve from a set distance to
simulate the impact (splatter) of blood or other body fluid onto the specimen. The velocity and volume of fluid are set to simulate
a given healthcare scenario.
4.2 Any evidence of synthetic blood penetration on the inner facing of the medical face mask (side contacting the wearer’s face)
constitutes a failure. Results are reported as pass/fail.
F1862/F1862M − 24
4.3 Specimen medical face masks are evaluated at velocities of 450, 500, andor 635 cm/s. These correspond to the velocity exiting
a small arterial puncture at human blood pressures of 10.7, 16.0, andor 21.3 kPa (80, 120, andor 160 mmHg). Test results Results
are reported atfor each velocity or corresponding pressure, and the medical face mask is rated at the highest corresponding blood
pressure for which medical face mask specimens demonstrate an acceptable quality limit of 4.0.pressure tested.
5. 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 are 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. 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 0.042
6 0.002 N/m.40 6 5 dyn/cm (0.040 6 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 high-velocity stream of
blood impacting a protective medical face mask. The impact velocity depends on several factors, the most important being the
blood pressure of the patient. Other factors include the size of the puncture and distance from the puncture. Because the pressure,
and thus velocity drops quickly with large punctures, large punctures were not used to model the range of blood splatter velocities
considered in this test. Furthermore, this test method is based on the assumption that the medical face mask will be in close
proximity (within 300 mm or 12 in.) to the puncture area. The use of this test method is, therefore, based on selecting an appropriate
blood pressure, finding the corresponding stream or impact velocity, and determining the valve time to create that stream velocity
as shown in Appendix X1.
5.4.1 The mean human blood pressure generally varies over a range of about 10.7 to 16.0 kPa (80 to 120 mmHg). In this test
method, medical face masks are tested at stream velocities corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg, 120
mmHg, and 160 mmHg).
5.5 This test method permits the use of other non-standard test pressures, stream velocities, fluid volumes, and specimen
orientations for evaluating medical face mask penetration resistance consistent with specific applications.
5.6 This test method differs from Test Method F1670/F1670M by dispensing a stream of 2 mL of synthetic blood against the target
area of a complete medical mask specimen, whereas Test Method F1670/F1670M involves the continuous contact of a specimen
of protective clothing with synthetic blood over the period of an hour. One minute of the exposure in Test Method F1670/F1670M
is at hydrostatic pressure of 13.8 kPa [2.0 psig]. Test Method F1670/F1670M is used for preliminary evaluation of protective
clothing penetration resistance to synthetic blood in conjunction with Test Method F1671/F1671M that uses a microbiological
challenge. Both procedures are intended for assessment of protective clothing which has the potential to contact blood or other
body fluids for extended periods of time, and under pressure.
5.7 Users of this test method must realize that certain tradeoffs exist between improved resistance of medical face masks to
penetration by synthetic blood and in pressure drop across mask materials as an indicator of medical face mask breathability. In
Lentner, C., ed., Geigy Scientific Tables, Vol 1 – Units of Measurement, Body Fluids, Composition of Blood, Hematology, Somatometric Data, Medical Education Div.,
Ciba-Geigy Corp., West Caldwell, NJ, 1984.
Barach, P. G., Cullen, B. F., and Stoelting, R. K., Handbook on Clinical Anesthesia, Appendix A, J. B. Lippincott Co., Philadelphia, 1994.
F1862/F1862M − 24
general, increasing synthetic blood penetration resistance for medical face masks results in increasing pressure drop or reduced
breathability for medical face masks of the same design and fit of the individual wearer.
5.8 This test method evaluates medical face masks as an item of protective clothing and does not evaluate medical face masks as
respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator must be used. This test method is useful
to evaluate the resistance of a respirator to penetration by synthetic blood, if warranted.
5.9 This test method involves the preconditioning of specimen medical face masks in a relatively high humidity environment (85
6 5 % relative humidity at 21 6 5 °C [70 6 10 °F]) to simulate the conditions of use when the wearer creates high humidity
conditions by breathing through the mask. This preconditioning does not account for saturation of the interior medical face mask
layer. However, additional pretreatment techniques in conjunction with this test method as described in 5.10 are permitted.
Professional healthcare providers recommend that medical face masks be replaced when saturation occurs from breathing or from
contact with other liquids.
5.10 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of
the protective barrier,barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions
and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the
protective clothing is occasionally compromised during use by such effects as flexing and abrasion. It is also possible that
pre-wetting by contaminants such as alcohol and perspiration also compromises the integrity of the protective clothing. If these
conditions are of concern, evaluate the performance of protective clothing for synthetic blood penetration following an appropriate
pretreatment technique representative of the expected conditions of use.
5.11 While this test method involves a qualitative determination of the medical face mask resistance to penetration by synthetic
blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure.
5.12 If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets when more than
the required specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested,
the average percent passing or failing, or both, with a standard deviation. Data reported to determine the required number of
specimens to be tested. Sampling conducted in this way helphelps to establish confidence limits concerning product performance.
The sampling plan or statistical approach selected should be designated or approved by the relevant responsible authority.
Examples of acceptable sampling plans are found in references such as ANSI/ASQC Z1.4 and ISO 2859-1.the ISO 2859 series of
standards for inspection by attributes and ANSI/ASQC Z1.4 and ANSI/ASQC Q3.
NOTE 1—Guidance on the selection of acceptance sampling plans can be found in references such as ISO/TR 8550-1 and ISO/TR 8550-2.
NOTE 2—Subject to the purpose of testing the relevant responsible authority may be a first, second, or third party. Further information about responsible
authorities in the context of acceptance sampling plans (including examples, duties, and functions) can be found in references such as ISO 2859-1.
5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of
commercial shipments, conduct comparative tests between the purchaser and supplier to determine if there is a statistical bias
between their laboratories. Competent statistical assistance is recommended for investigation of bias. At minimum, take a group
of test specimens which are as homogeneous as possible and which are from a lot of the product of the type in question. Randomly
assign test specimens in equal numbers to each laboratory for testing. Compare the average results from the two laboratories using
a non-parametric test for unpaired data and an acceptable probability level chosen by the two parties before testing is begun. If
a bias is found, either its cause must be found and corrected or the purchaser and the supplier must agree to interpret future test
results with consideration to the known bias.
6. Apparatus
6.1 Test Apparatus, to dispense a specified volume of synthetic blood through a small diameter cannulanozzle over a controlled
amount of time at a specimen mask a set distance away. The test apparatus consists of a specimen holding fixture, a targeting plate,
a pressurized fluid reservoir, a pneumatically actuated valve with interchangeable cannula, valve, delivery nozzle, and a valve
controller. A permitted optional design for the test apparatus includes a base for more convenient mounting of the components and
Telford, G. L. and Quebbeman, E. J., “Assessing the Risk of Blood Exposure in the Operating Room,” American Journal of Infection Control, Vol 21, No. 6, December
1993, pp. 351–356.
F1862/F1862M − 24
S = Specimen Holder T = Targeting Plate with Collection Cups
R = Pressurized Fluid Reservoir C = Cannula
R = Pressurized Fluid Reservoir N = Nozzle
V = Valve VC = Valve Timing Controller
VS = Valve Switch
FIG. 1 (a) Test Apparatus
a hood or other components to contain or control the splash. A photograph of a typical sample test apparatus is provided in Fig.
1(a). Fig. 1(b) provides an example of an alternative apparatus with the addition of a funnel to collect excess liquid so that the level
in the reservoir can be estimated to help prevent running out of synthetic blood in the middle of a test lot. Fig. 1(c) and Fig. 1(d)
show the incorporation of X-Y-Z axis slides for easy, smooth fine-tuning of cannula position thatthe nozzle position and also helps
keep the pneumatic valve steady to reduce the risk of accidentally bumping it out of adjustment. Other specifications for the
specimen holding fixture include as follows:
6.1.1 Specimen Holding Fixture, to support the specimen mask during the test. The design and construction of the specimen
holding fixture has a significant impact on the outcome of the test. The specimen holder and supporting frame must be sufficiently
stiff and rigid that the energy of the impact of the spurt is absorbed solely by the specimen mask. The specimen holder and frame
must not deform, flex, or bend during a test. If necessary, alter the fixture design details from that described below, in order to
provide appropriate specimen presentation while maintaining the intent of the method described herein.
6.1.1.1 The standard backing form for the specimen holder is a solid section of a 12.7-cm [5-in.] 12.7 cm [5 in.] diameter sphere.
Use a form made of a material with a Shore A hardness of at least 40. (See Note 13.) The form has a 5.7-cm [2.25-in.] 5.7 cm
[2.25 in.] diameter viewing hole through its center as shown in Fig. 2Figs. 2 and 3 and Fig. 3.
NOTE 3—A backing form can be made from liquid polyester resin (found at home improvement centers or auto parts stores), a 5-in. 5 in. ball candle mold
(candle supply companies such as genwax.com), and a 2-in. companies), and a 2 in. PVC tubing union (2.25 in., 5.7 cm (5.7 cm [2.25 in.] outside
diameter, found at home improvement centers). Mark a ring around the outside of the union 1 3.0 cm [1 ⁄8 in. [3.0 cm] in.] from one end. This will indicate
the proper depth to fill the form to fit the apparatus described in this method. The depth can be adjusted to accommodate variations in the design of the
specimen mask holder. The key element is to maintain the diameter of the form at the plane of the cuff at 4.125 in. [10.5 cm].10.5 cm [4.125 in.]. Using
plumber’s putty on the end of the union opposite the depth mark, seal the union to the inside of one half of the ball mold. Set the mold in the mold stand.
Rest a level on the union to ensure the hold is horizontal in all directions. Mix about 12 oz 355 mL [12 fl oz] of resin and 25 drops of hardener in a
well-ventilated area. Carefully pour the resin into the mold outside of the union, making an annular form. Fill the mold up to the line on the union, taking
into account the meniscus of the fluid. Once hardened, remove the form from the mold and the union from the mold. The use of a short piece of 2-in.
F1862/F1862M − 24
FIG. 1 (b) Test Apparatus (continued)
2 in. PVC tubing is suitable to carefully knock the union out of the mold. Sand the base of the mold such that the surface is flush. Drill and tap mounting
holes into the mold.
6.1.1.2 The backing form is mounted to a plate which is hinged to the specimen holder frame so there is a 0.6-cm [0.25-in.] 0.6
5 5
cm [0.25 in.] gap between the plate and the frame, as in Fig. 2. The frame contains an 11.75-cm 11.75 cm [4 ⁄8 ⁄8-in.]in.] hole to
receive the backing form.
6.1.1.3 A rubber cuff which partially covers the hole is secured to the frame. The cuff draws the specimen mask across the backing
form. Use a cuff made from 0.08-cm 0.08 cm [ ⁄32-in.] in.] buna-N gasket material with a Shore A hardness of 70. The dimensions
of the six-point star-shaped opening in the cuff are detailed in Fig. 4.
6.1.2 Targeting Plate, to block the high-velocity leading edge of the fluid stream and to provide a means of ensuring the fluid
stream hits the target area of the specimen mask. The plate contains a 0.48 cm [ ⁄16-in. in.] diameter hole. Ensure that the thickness
of the targeting plate at the hole does not exceed 0.48 cm [ ⁄16 in.in.] beyond the hole and is made of clear plastic. The plate is
configured upright and placed approximately 1.27 cm [ ⁄2 in.in.] in front of the specimen mask, between the mask and the
cannula,nozzle, such that the stream impacts the center of hole in the mask supporting form.
A continuous plastic hinge provides a little more give than a rigid piano hinge. Reference McMaster Carr 11195A41. McMaster-Carr Supply Company, Atlanta, Georgia.
10 1
Reference McMaster-Carr item 8635K161 – 12 in. by 12 in. sheets of 70A hardness ⁄32 in. thick Buna-N gasket material. McMaster-Carr Supply Company, Atlanta,
Georgia.
F1862/F1862M − 24
FIG. 1 (c) Left/Right and Vertical Adjustment (continued)
6.1.2.1 A suitable method for containing the splatter of fluid hitting the targeting plate uses a disposable plastic cup with a hole
3 3
larger than ⁄16 in. 0.48 cm [ ⁄16 in.] diameter cut out of the bottom. The cup is mounted horizontally with the opening facing the
nozzle by any convenient method. The run-off is suitably collected by a second cup placed below the lip of targeting cup, as shown
in Fig. 1.
6.1.3 Pneumatically Actuated Valve, shall be mounted on a stiff support, such as a ring stand. The valve support shall not flex
when the valve is actuated. The valve shall be positioned so that the exit of the cannulanozzle is 30.5 cm [12.0 in.] from the point
of impact on the specimen mask.
6.1.3.1 Valve Maintenance—Periodically disassemble and clean the pneumatically actuated valve with isopropanol to prevent
interference with the valve mechanism or plugging of the cannula,nozzle, which can lead to inconsistent valve performance.
6.1.4 Valve Controller, to set the duration of the fluid spurt. Use a valve controller with a resolution and accuracy of at least 0.01
6 0.005 s.
6.1.5 Cannula,Nozzle, which attaches to the exit of the valve. valve for delivering the spurt. The standard for this method is a
1.27-cm [0.5-in.] 1.27 cm [0.5 in.] long, 18 gauge stainless steel cylindrical tube cannula with an internal diameter of 0.084 cm
[0.033 in.].
6.1.5.1 Deviations from the standard cannulanozzle must be noted in the test report.
11 3
Reference McMaster-Carr 3427A57 – ⁄16-in. in. Arch Punch for making the targeting plate holes in soft materials. McMaster-Carr Supply Company, Atlanta, Georgia.
Reference NORDSON EFD ModelLLC, 725D pneumatic fluid dispensing valve or equivalent. EFD, 977 Waterman Ave. NORDSON EFD LLC, 40 Catamore Blvd.
East Providence, RI 02914.
Reference NORDSON EFD LLC, 1500D controller or equivalent. A remote hand or foot actuated switch can also be used with the 1500D controller. EFD, 977 Waterman
Ave. NORDSON EFD LLC, 40 Catamore Blvd. East Providence, RI 02914.
Reference NORDSON EFD LLC, Part Number 5118-B. EFD, 977 Waterman Ave. NORDSON EFD LLC, 40 Catamore Blvd. East Providence, RI 02914.
F1862/F1862M − 24
FIG. 1 (d) Forward and Backward Adjustment (continued)
6.1.6 Pressure-Regulated Fluid Reservoir, to contain the synthetic blood for delivery to the nozzle.valve/nozzle assembly.
6.2 Air Pressure Source, capable of providing air at a gauge pressure recommended by manufacturer of valve controller.
6.3 Balance, calibrated to measure weight with a precision of at least 0.01 g.
6.4 Beaker or Cup, to collect the synthetic blood discharged from the nozzle and cannula.nozzle.
6.5 Temperature/Humidity Recorder, to monitor ambient conditions during testing.
6.6 Controlled Temperature and Humidity Chamber or Space, capable of achieving and maintaining specified temperature and
humidity conditions.
7. Reagents
7.1 Synthetic Blood —If synthetic blood is not purchased, prepare using the following ingredients:
Reference NORDSON EFD LLC, parts: 615DTH fluid reservoir; 615DRL fluid reservoir cover and liner; 61520 reservoir stand; 2000f755 air filter and regulator; 1116
air tree EFD, 977 Waterman Ave. tree. NORDSON EFD LLC, 40 Catamore Blvd. East Providence, RI 02914.
Weighing the fluid output is faster and more accurate than measuring the fluid volume.
Prepared synthetic blood meeting this specification, and small quantities of Direct Red 081, CI No. 28160 (Morfast Red 8BL) are available from JM & Co.,
507-208-6390. Acrysol G111 is available from Dow Chemical Company.
F1862/F1862M − 24
FIG. 2 Schematic of Specimen Holding Fix
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