ASTM F1819-07(2013)
(Test Method)Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique
SIGNIFICANCE AND USE
5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test.8 The Elbow Lean Test involves the application of synthetic blood to an ink pad, placement of sample fabric over the blood soaked pad, placement of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and application of pressure through an adopted methodology.
5.2 This test method is intended to simulate actual use conditions wherein areas of the health care worker's protective clothing are soaked with blood and compressed between the patient's body and that of the health care worker, or similarly between the health care worker and instruments. In both cases, unconfined blood can move away from the pressure point taking the path of least resistance rather than being contained as in Test Methods F1670 and F1671.
5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate liquid penetration resistance (1,2) . It simulates a single insult in which the outer surfaces of a protective clothing item are compressed at a steady rate by the wearer's body against a wet surface. This steady rate of compression represents one potential use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test apparatus.
5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure for protective clothing materials which do not pass Test Method F1670.
5.5 This test method is normally used to evaluate specimens from individual finished items of protective clothing and individua...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure.
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 work/clothing exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.
1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.5 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.
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Designation: F1819 − 07 (Reapproved 2013)
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood Using a Mechanical
Pressure Technique
This standard is issued under the fixed designation F1819; 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 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
ImmunodeficiencyViruses(HIV)).Sinceengineeringcontrolscannoteliminateallpossibleexposures,
attention is placed on reducing the potential for direct skin contact through the use of protective
clothing that resists penetration (29 CFR Part 1910.1030). This test method was developed to help
assess the effectiveness of materials used in protective clothing for protecting the wearer against
contact with body fluids that potentially contain blood-borne pathogens. Using synthetic blood, this
test method is intended to determine the amount of mechanical pressure that will cause penetration of
a liquid through a material used in protective clothing.
1. Scope 1.4 The values in SI units or in other units shall be regarded
separately as standard. The values stated in each system must
1.1 This test method is used to evaluate the resistance of
be used independently of the other, without combining values
materials used in protective clothing to synthetic blood under
in any way.
the conditions of liquid contact and increasing direct mechani-
1.5 This standard does not purport to address all of the
cal pressure. The penetration resistance of protective clothing
safety concerns, if any, associated with its use. It is the
is based on visual detection of synthetic blood penetration at a
responsibility of the user of this standard to establish appro-
specific applied mechanical pressure.
priate safety and health practices and determine the applica-
1.2 This test method does not apply to all forms or condi-
bility of regulatory limitations prior to use.
tions of blood-borne pathogen exposure. Users of the test
method must review modes for work/clothing exposure and
2. Referenced Documents
assess the appropriateness of this test method for their specific
2.1 ASTM Standards:
application.
D1331 Test Methods for Surface and Interfacial Tension of
1.3 This test method addresses only the performance of
Solutions of Paints, Solvents, Solutions of Surface-Active
materials or certain material constructions (for example,
Agents, and Related Materials
seams) used in protective clothing. This test method does not
D1777 Test Method for Thickness of Textile Materials
address the design, overall construction, components, or inter-
D3776 Test Methods for Mass Per Unit Area (Weight) of
facesofgarments,orotherfactorswhichmayaffecttheoverall
Fabric
protection offered by the protective clothing.
E105 Practice for Probability Sampling of Materials
E171 Practice for Conditioning and Testing Flexible Barrier
Packaging
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal
Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Jan. 1, 2013. Published January 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2007 as F1819-07. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1819-07R13. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1819 − 07 (2013)
E691 Practice for Conducting an Interlaboratory Study to 3.1.6.1 Discussion—Forthistestmethod,thespecificmatter
Determine the Precision of a Test Method is synthetic blood.
F1494 Terminology Relating to Protective Clothing
3.1.7 protective clothing, n—an item of clothing that is
F1670 Test Method for Resistance of Materials Used in
specifically designed and constructed for the intended purpose
Protective Clothing to Penetration by Synthetic Blood
of isolating all or part of the body from a potential hazard; or,
F1671 Test Method for Resistance of Materials Used in
isolating the external environment from contamination by the
Protective Clothing to Penetration by Blood-Borne Patho-
wearer of the clothing.
gens Using Phi-X174 Bacteriophage Penetration as a Test
3.1.7.1 Discussion—Inthistestmethod,thepotentialhazard
System
of contact with blood or other body fluids is simulated.
2.2 ANSI/ASQC Standards:
3.1.8 synthetic blood, n—a mixture of a red dye/surfactant,
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
thickening agent, and distilled water having a surface tension
spection by Attributes
and viscosity representative of blood and some other body
2.3 ISO Standard:
fluids, and the color of blood.
ISO 2859-1 Sampling Plans for Inspection by Attributes
3.1.8.1 Discussion—The synthetic blood in this test method
2.4 Military Standard:
doesnotsimulateallofthecharacteristicsofrealbloodorbody
MIL-STD-105 Sampling Procedures and Tables for Inspec-
fluids, for example, polarity (a wetting characteristic),
tion by Attributes
coagulation, content of cell matter.
2.5 OSHA Standard:
3.1.9 For definitions of other protective clothing-related
CFR Part 1910.1030 Occupational Exposure to Blood-borne
terms used in this test method, refer to Terminology F1494.
Pathogens: Final Rule, Federal Register, Vol 56, No 235,
Dec. 6, 1991, pp. 64175–64182.
4. Summary of Test Method
3. Terminology 4.1 Using a special test apparatus, a specimen is contacted
with synthetic blood under a continuously increasing mechani-
3.1 Definitions:
cal pressure until the synthetic blood penetrates the specimen
3.1.1 blood-borne pathogen, n—an infectious bacterium,
or a load of 90.7 kg (200 lbs) is applied to a 57.2 mm (2.25 in.)
virus, or other disease inducing microbe carried in blood or
diameter portion of the specimen achieving a pressure on the
other potentially infectious body fluids.
tested specimen of 345 kPa (50 psig).
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
4.2 The specimen’s non-contact side is observed to deter-
creted by the human body.
mineifvisualpenetrationoccurs,andifso,atwhatmechanical
3.1.2.1 Discussion—In this test method, body fluids include
pressure the penetration occurs.
those liquids potentially infected with blood-borne pathogens,
including, but not limited to, blood, semen, vaginal secretions,
4.3 In conducting a test, the cover plate containing a test
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
head is locked on the two side supports of the base plate of the
otic fluid, saliva in dental procedures, and any body fluid that
testapparatus,themulti-positionswitchisturnedtothemanual
is visibly contaminated with blood, and all body fluids in
upposition,andthetestbuttonontopofthecontrolboxisheld
situations where it is difficult or impossible to differentiate
downuntilvisiblepenetrationofthetestspecimenbysynthetic
between body fluids (see 29 CFR Part 1910.1030).
blood is observed through the circular test head. Releasing the
button stops the drive motor, and the penetration pressure is
3.1.3 body fluid simulant, n—a liquid which is used to act as
shown digitally on the display unit and recorded by the
a model for human body fluids.
technician.
3.1.4 hydrostatic pressure, n—the force exerted by a static
liquid (1).
5. Significance and Use
3.1.5 mechanical pressure, n—the force exerted by one
5.1 This test method was modeled after a procedure com-
solid object upon another that it is touching (1). 8
monly known as the Elbow Lean Test. The Elbow Lean Test
3.1.6 penetration, n—the movement of matter through
involves the application of synthetic blood to an ink pad,
closures, porous materials, seams, and pinholes or other
placement of sample fabric over the blood soaked pad, place-
imperfections in protective clothing on a nonmolecular level.
mentofablotteroverthesamplefabric,andapplyingelbowor
fingertip pressure on top of the blotter. The blotter is then
examined for staining as evidence of blood penetration. This
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
test method provides similar procedures which standardize the
Milwaukee, WI 53203, http://www.asq.org.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
test equipment and application of pressure through an adopted
4th Floor, New York, NY 10036, http://www.ansi.org.
methodology.
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
5.2 This test method is intended to simulate actual use
dodssp.daps.dla.mil.
conditions wherein areas of the health care worker’s protective
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
clothing are soaked with blood and compressed between the
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
The boldface numbers in parentheses refer to the list of references at the end of
this standard. Originally developed by W.L.Gore and Assoc., Inc., Elkton, MD 21921.
F1819 − 07 (2013)
patient’s body and that of the health care worker, or similarly 5.9 Part of the protocol for exposing the protective clothing
between the health care worker and instruments. In both cases, material specimens to synthetic blood involves applying me-
unconfined blood can move away from the pressure point chanical pressure up to 345 kPa (50 psig). This mechanical
taking the path of least resistance rather than being contained pressurehasbeendocumentedtodiscriminateprotectivecloth-
as in Test Methods F1670 and F1671. ing material performance and correlate with visual penetration
results that are obtained with one type of human factors
5.3 This test method uses predominately mechanical pres-
validation, the Elbow Lean Test. The Elbow Lean Test does
sure as opposed to contained, hydrostatic pressure to demon-
not simulate all of the possible types of clinical exposure as
strate liquid penetration resistance (1, 2). It simulates a single
thereisonecontactwithliquidunderhighmechanicalpressure
insult in which the outer surfaces of a protective clothing item
for a short duration. Some studies suggest that mechanical
are compressed at a steady rate by the wearer’s body against a
pressures exceeding 345 kPa (50 psig) can occur during
wet surface. This steady rate of compression represents one
clinical use (7, 8).
potential use scenario. Other scenarios may result in a wide
variety of pressure ramp rates and profiles that are not
NOTE 1—The mechanical pressure tester can be adjusted to evaluate
simulated by the test apparatus. materials at higher pressures.
5.4 Because this test method provides quantitative results, it 5.10 Testing prior to degradation by physical, chemical, and
is useful for discriminating differences in the liquid barrier thermal stresses which could negatively impact the perfor-
performance of protective clothing materials. This test method mance of the protective barrier, could lead to a false sense of
can be used for measuring differences in the penetration security. Consider tests which assess the impact of storage
pressure for protective clothing materials which do not pass conditions and shelf life for disposable products, and the
Test Method F1670. effects of laundering and sterilization for reusable products.
The integrity of the protective clothing can also be compro-
5.5 Thistestmethodisnormallyusedtoevaluatespecimens
mised during use by such effects as flexing and abrasion (9).It
from individual finished items of protective clothing and
is also possible that prewetting by contaminants such as
individual samples of materials that are candidates for items of
alcohol and perspiration can compromise the integrity of the
protective clothing.
protective clothing. Furthermore, high relative humidity may
5.5.1 Finished items of protective clothing include gloves,
also affect the resistance of materials used in protective
arm shields, aprons, gowns, hoods, and boots.
clothing to penetration by blood and other body fluids. If these
5.5.2 The phrase specimens from finished items encom-
conditions are of concern, evaluate the performance of protec-
passes seamed and other discontinuous regions as well as the
tive clothing for synthetic blood penetration following an
usual continuous regions of protective clothing items.
appropriate pretreatment technique representative of the ex-
5.6 Medical protective clothing materials are intended to be
pected conditions of use.
a barrier to blood, body fluids, and other potentially infectious
5.11 This test method involves a quantitative determination
materials. Many factors can affect the wetting and penetration
of a protective clothing penetration resistance to synthetic
characteristics of body fluids, such as surface tension,
blood under specific test conditions. It can also be used as a
viscosity, and polarity of the fluid, as well as the structure and
qualitative method for comparing the penetration resistance
relative hydrophilicity or hydrophobicity of the materials. The
characteristics of similar materials and as a material quality
synthetic blood solution may exhibit different wetting behavior
control or assurance procedure.
on fabrics or films with identical structures but different
chemical compositions. The surface tension range for blood
5.12 If this test method is used for quality control, perform
and body fluids (excluding saliva) is approximately 0.042 to
proper statistical design and analysis of larger data sets where
0.060 N/m (3). To help simulate the wetting characteristics of
more than three specimens are tested. This type of analysis
blood and body fluids, the surface tension of the synthetic
includes, but is not limited to, reporting the number of
blood is adjusted to approximate the lower end of this surface
individual specimens tested and the average penetration pres-
tension range. The resulting surface tension of
...
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