ASTM F1862-00a
(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)
SCOPE
1.1 This test method is used to evaluate the resistance of medical face masks to penetration by synthetic blood under high velocity liquid contact with the medical face mask surface of a fixed volume over a relatively short period of time (0 to 2.5 s). 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 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 factors which may 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 MIL-M-36954C.
1.4 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.
1.5 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F 1862–00a
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 F 1862; 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 (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Workers, primarily those in the health care 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 can not 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 ranking the synthetic blood penetration resistance performance of medical
face 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.
1. Scope 1.4 This test method does not address breathability of the
medical face mask materials or any other properties affecting
1.1 This test method is used to evaluate the resistance of
the ease of breathing through the medical face mask. This test
medical face masks to penetration by synthetic blood under
method evaluates medical face masks as an item of protective
highvelocityliquidcontactwiththemedicalfacemasksurface
clothing. This test method does not evaluate the performance
ofafixedvolumeoverarelativelyshortperiodoftime(0to2.5
ofmedicalfacemasksforairborneexposurepathwaysorinthe
s). Medical face mask pass/fail determinations are based on
prevention of the penetration of aerosolized body fluids depos-
visual detection of synthetic blood penetration.
ited on the medical face mask.
1.2 This test method does not apply to all forms or condi-
1.5 The values stated in SI units or inch-pound units are to
tions of blood-borne pathogen exposure. Users of the test
be regarded separately as standard. The values stated in each
method must review modes for face exposure and assess the
system may not be exact equivalents, therefore, each system
appropriateness of this test method for their specific applica-
shall be used independently of the other.
tion.
1.6 This standard does not purport to address all of the
1.3 Thistestmethodprimarilyaddressestheperformanceof
safety concerns, if any, associated with its use. It is the
materials or certain material constructions used in medical face
responsibility of the user of this standard to establish appro-
masks. This test method does not address the performance of
priate safety and health practices and determine the applica-
the medical face mask’s design, construction, or interfaces or
bility of regulatory limitations prior to use.
other factors which may affect the overall protection offered by
the medical face mask and its operation (such as filtration
2. Referenced Documents
efficiency and pressure drop). Procedures for measuring these
2.1 ASTM Standards:
properties are contained in MIL-M-36954C.
D 1331 Test Methods for Surface and Interfacial Tension in
Solutions of Surface-Active Agents
E 105 Practice for Probability Sampling of Materials
This test method is under the jurisdiction of ASTM Committee F23 on
Protective Clothing and is the direct responsibility of Subcommittee F23.40 on
Biological Hazards.
Current edition approved July 10, 2000. Published August 2000. Originally Annual Book of ASTM Standards, Vol. 15.04
published as F 1862 - 98. Last previous edition F 1862 - 00. Annual Book of ASTM Standards, Vol. 14.02
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1862
E 171 Specification for Standard Atmospheres for Condi- mucous membrane areas of the wearer’s nose and mouth, from
tioning and Testing Flexible Barrier Materials contact with blood and other body fluids during medical
F 1494 Terminology Relating to Protective Clothing procedures.
F 1670 Test Method for Resistance of Materials used in 3.1.7 penetration, n— for biological protective clothing, the
Protective Clothing to Penetration by Synthetic Blood flow of a body fluid on a non-molecular level through closures,
F 1671 Test Method for Resistance of Materials Used in porousmaterials,seamsandpinholes,orotherimperfectionsin
Protective Clothing to Penetration by Blood-borne Patho- protective clothing.
gens Using Phi-X174 Bacteriophage Penetration as a Test 3.1.7.1 Discussion—In this test method, the penetration
System
liquid is synthetic blood, a body fluid simulant.
2.2 ANSI/ASQC Standard: 3.1.8 protective clothing, n—anymaterialorcombinationof
materials used in an item of clothing for the purpose of
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
isolating parts of the body from potential hazards.
spection by Attributes
3.1.8.1 Discussion—Inthistestmethod,medicalfacemasks
2.3 ISO Standard:
are evaluated. The potential hazard of contact with blood or
ISO 2859-1 Sampling Plans for Inspection by Attributes
other body fluids is being simulated.
2.4 Military Standards:
3.1.9 synthetic blood, n—a mixture of a red dye/surfactant,
MIL-M-36954C Military Specification, Mask, Surgical,
thickening agent, and distilled water having a surface tension
Disposable
and viscosity representative of blood and some other body
MIL-STD-105 Sampling Procedures and Tables for Inspec-
fluids, and the color of blood.
tion by Attributes
3.1.9.1 Discussion—The synthetic blood in this test method
2.5 OSHA Standard
does not simulate all of the characteristics of blood or body
29 CFR Part 1910.1030 Occupational Exposure to Blood-
fluids, for example, polarity (wetting characteristics), coagula-
bornePathogens:FinalRule, Federal Register,Vol56,No
tion, content of cell matter.
235, Dec. 6, 1991, pp. 64175–64182
3.1.10 For definitions of other protective clothing-related
terms used in this test method, refer to Terminology F 1494.
3. Terminology
3.1 Definitions:
4. Summary of Test Method
3.1.1 aerosolized body fluids, n—body fluids which have
4.1 A specimen is supported on an apparatus that allows
been dispersed into air as very small liquid droplets.
viewing from behind. A fixed volume of synthetic blood,
3.1.2 airborne exposure pathways, n—inhalation routes of
simulating a given health care scenario, is aimed at the
exposure to the medical face mask wearer.
specimenanddispersedataknownvelocitybyapneumatically
3.1.3 blood-borne pathogen, n—an infectious bacterium or
controlled valve to simulate the impact (splatter) of blood or
virus, or other disease inducing microbe carried in blood or
other body fluid onto the specimen. The speed and volume
other potentially infectious body fluids.
selected corresponds to a specific blood pressure spurting
3.1.4 body fluid, n—any liquid produced, secreted, or ex-
through a defined orifice size.
creted by the human body.
4.2 Any evidence of synthetic blood penetration on the
3.1.4.1 Discussion—In this test method, body fluids include
viewing side of the medical face mask constitutes failure.
liquids potentially infected with blood-borne pathogens, in-
Results are reported as pass/fail.
cluding, but not limited to, blood, semen, vaginal secretions,
4.3 Specimen medical face masks are evaluated at a total of
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
three different velocities corresponding to human blood pres-
otic fluid, saliva in dental procedures, and any body fluid that
sures of 10.6, 16.0, and 21.3 kPa (80, 120, and 160 mm Hg).
is visibly contaminated with blood, and all body fluids in
Test results are reported at each velocity and the medical face
situations where it is difficult or impossible to differentiate
mask is rated at the highest corresponding blood pressure for
between body fluids (see 29 CFR Part 1910.1030).
whichmedicalfacemaskspecimensdemonstrateanacceptable
3.1.5 body fluid simulant, n—aliquidwhichisusedtoactas
quality limit of 4.0.
a model for human body fluids.
3.1.6 medical face mask, n—an item of protective clothing
5. Significance and Use
designed to protect portions of the wearer’s face including the
5.1 This test method offers a procedure for evaluating
medical face mask resistance to synthetic blood penetration
that can be useful in establishing claims for penetration
Annual Book of ASTM Standards, Vol. 15.09
resistance performance of medical face masks and ranking
Annual Book of ASTM Standards, Vol. 11.03
their performance. However, this test method does not define
Available from American Society for Quality Control, 611 E. Wisconsin Ave.,
acceptable levels of penetration resistance because this deter-
Milwaukee, WI 53202.
mination must be made by each responsible user organization
Available from American National Standards Institute, 11 W. 42nd Str., 13th
floor, New York, NY 10036.
based on its own specific application and conditions. There-
AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
fore, when using this test method to make claims for the
Robbins Ave., Philadelphia, PA 19111–5094, Attn: NPODS.
performance of medical face masks, the specific conditions
Available from Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. under which testing is conducted must be described.
F 1862
5.2 Medical face masks are intended to resist liquid pen- clothing which has the potential to contact blood or other body
etration from the splatter or splashing of blood, body fluids, fluids for extended periods of time, and under pressure.
and other potentially infectious materials. Many factors can
5.7 Users of this test method should realize that certain
effectthewettingandpenetrationcharacteristicsofbodyfluids,
tradeoffs exist between improved resistance of medical face
such as surface tension, viscosity, and polarity of the fluid, as
masks to penetration by synthetic blood and in pressure drop
well as the structure and relative hydrophilicity or hydropho-
across mask materials as an indicator of medical face mask
bicity of the materials.The surface tension range for blood and
breathability.Ingeneral,increasingsyntheticbloodpenetration
body fluids (excluding saliva) is approximately 0.042 to 0.060
resistance for medical face masks results in increasing pressure
N/m(1). Tohelpsimulatethewettingcharacteristicsofblood
drop or reduced breathability for medical face masks of the
and body fluids, the surface tension of the synthetic blood is
same design and fit of the individual wearer.
adjusted to approximate the lower end of this surface tension
5.8 This test method evaluates medical face masks as an
range. The resulting surface tension of the synthetic blood is
item of protective clothing and does not evaluate medical face
0.042 6 0.002 N/m.
masks as respirators. If respiratory protection for the wearer is
5.3 The synthetic blood mixture is prepared with a red dye
needed, a MSHA/NIOSH-certified respirator should be used.
to aid in visual detection and a thickening agent to simulate the
This test method can be used to evaluate the resistance of a
flow characteristics of blood. The synthetic blood may not
respirator to penetration by synthetic blood, if warranted.
duplicate the polarity, and thus the wetting behavior and
5.9 This test method involves the preconditioning of speci-
subsequent penetration, of real blood and other body fluids
men medical face masks in a relatively high humidity environ-
through protective clothing materials.
ment (856 5 % relative humidity at 25 + 3°C (77 6 5°F)) to
5.4 During a medical procedure, a blood vessel can be
simulate the conditions of use when the wearer creates high
punctured resulting in a high velocity stream of blood impact-
humidity conditions by breathing through the mask. This
ing a protective medical face mask. The impact velocity
preconditioning does not account for saturation of the interior
depends on several factors, the most important being the blood
medical face mask layer. However, additional pretreatment
pressure of the patient. A second factor is the size of the
techniques may be used in conjunction with this test method as
puncture, and a third factor is the distance from the puncture.
described in 5.10. Professional health care providers recom-
Because only small punctures cause high velocity streams,
mend that medical face masks be replaced when saturation
large punctures were not used to model the range of blood
occurs from breathing or from contact with other liquids.
splatter velocities considered in this test. Furthermore, this test
5.10 Testing prior to degradation by physical, chemical, and
method is based on the assumption that the medical face mask
thermal stresses which could negatively impact the perfor-
will be in close proximity to the puncture area. The use of this
mance of the protective barrier, could lead to a false sense of
test method is, therefore, based on selecting an appropriate
security. Consider tests which assess the impact of storage
blood pressure, finding the corresponding stream or impact
conditions and shelf life for disposable products, and the
velocity, and determining the valve time to create that stream
effects of laundering and sterilization for reusable products.
velocity as shown in Appendix X1.
The integrity of the protective clothing can also be compro-
5.4.1 The mean human blood pressure generally varies over
mised during use by such effects as flexing and abrasion (3).It
a range of about 10.6 to 16.0 kPa (80 to 120 mm Hg) (2).In
is also possible that pre-wetting by contaminants such as
this test method, medical face masks are tested at stream
alcohol and perspiration also compromises the integrity of the
velocities corresponding to 10.6 kPa, 16.0 kPa, and 21.3 kPa
protective clothing. If these conditions are of concern, evaluate
(80 mm Hg, 120 mm Hg, and 160 mm Hg).
the performance of protective clothing for synthetic blood
5.5 This test method permits the use of other non-standard
penetration following an appropriate pretreatment technique
test pressures, stream velocities, fluid volumes, and specimen
representative of the expected conditions of
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.