ASTM F1819-98
(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
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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Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
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Designation: F 1819 – 98
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 F 1819; 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 Viruses (HIV)). Since engineering controls cannot eliminate all possible exposures,
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.
D 1331 Test Methods for Surface and Interfacial Tension in
1.3 This test method addresses only the performance of
Solutions of Surface-Active Agents
materials or certain material constructions (for example,
D 1777 Test Method for Measuring Thickness of Textile
seams) used in protective clothing. This test method does not
Materials
address the design, overall construction, components, or inter-
D 3776 Test Method for Mass Per Unit Area (Weight) of
faces of garments, or other factors which may affect the overall
Fabric
protection offered by the protective clothing.
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 Annual Book of ASTM Standards, Vol. 15.04
Biological Hazards. Annual Book of ASTM Standards, Vol. 07.01
Current edition approved March 10, 1998. Published May 1998. Originally Annual Book of ASTM Standards, Vol. 07.02
published as F 1819-98. Last previous edition F 1819-97. 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.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F1819–98
E 171 Specifications for Standard Atmospheres for Condi- 3.1.6 penetration, n— for biological protective clothing, the
tioning and Testing Materials flow of a body fluid on a non-molecular level through closures,
E 691 Practice for Conducting an Interlaboratory Study to porous materials, seams, and pinholes or other imperfections in
protective clothing.
Determine the Precision of a Test Method
3.1.6.1 Discussion—In this test method, the penetration
F 1494 Terminology Relating to Protective Clothing
liquid is synthetic blood, a body fluid simulant.
F 1670 Test Method for Resistance of Materials Used in
3.1.7 protective clothing, n—any material or combination of
Protective Clothing to Penetration by Synthetic Blood
materials used in an item of clothing for the purpose of
F 1671 Test Method for Resistance of Materials Used in
isolating parts of the body from a potential hazard.
Protective Clothing to Penetration by Blood-Borne Patho-
3.1.7.1 Discussion—In this test method, the potential haz-
gens Using Phi-X174 Bacteriophage Penetration as a Test
ard of contact with blood or other body fluids is simulated.
System
3.1.8 synthetic blood, n—a mixture of a red dye/surfactant,
2.2 ANSI/ASQC Standards
thickening agent, and distilled water having a surface tension
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
and viscosity representative of blood and some other body
Inspection by Attributes
9 fluids, and the color of blood.
2.3 ISO Standard
3.1.8.1 Discussion—The synthetic blood in this test method
ISO 2859-1 Sampling Plans for Inspection by Attributes
does not simulate all of the characteristics of real blood or body
2.4 Military Standard
fluids, for example, polarity (a wetting characteristic), coagu-
MIL-STD-105 Sampling Procedures and Tables for Inspec-
lation, content of cell matter.
tion by Attributes
3.1.9 For definitions of other protective clothing-related
2.5 OSHA Standard
terms used in this test method, refer to Terminology F 1494.
CFR Part 1910.1030 Occupational Exposure to Blood-
4. Summary of Test Method
borne Pathogens: Final Rule, Federal Register, Vol 56, No
235, Dec. 6, 1991, pp. 64175–64182.
4.1 Using a special test apparatus, a specimen is contacted
with synthetic blood under a continuously increasing mechani-
3. Terminology cal pressure until the synthetic blood penetrates the specimen
or a load of 90.7 kg (200 lbs) is applied to a 57.2 mm (2.25 in.)
3.1 Definitions:
diameter portion of the specimen achieving a pressure on the
3.1.1 blood-borne pathogen, n—an infectious bacterium,
tested specimen of 345 kPa (50 psig).
virus, or other disease inducing microbe carried in blood or
4.2 The specimen’s non-contact side is observed to deter-
other potentially infectious body fluids.
mine if visual penetration occurs, and if so, at what mechanical
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
pressure the penetration occurs.
creted by the human body.
4.3 In conducting a test, the cover plate containing a test
3.1.2.1 Discussion—In this test method, body fluids include
head is locked on the two side supports of the base plate of the
those liquids potentially infected with blood-borne pathogens,
test apparatus, the multi-position switch is turned to the manual
including, but not limited to, blood, semen, vaginal secretions,
up position, and the test button on top of the control box is held
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
down until visible penetration of the test specimen by synthetic
otic fluid, saliva in dental procedures, and any body fluid that
blood is observed through the circular test head. Releasing the
is visibly contaminated with blood, and all body fluids in
button stops the drive motor, and the penetration pressure is
situations where it is difficult or impossible to differentiate
shown digitally on the display unit and recorded by the
between body fluids (see 29 CFR Part 1910.1030).
technician.
3.1.3 body fluid simulant, n—a liquid which is used to act as
a model for human body fluids.
5. Significance and Use
3.1.4 hydrostatic pressure, n—the force exerted by a static
5.1 This test method was modeled after a procedure com-
liquid (1)
monly known as the Elbow Lean Test. The Elbow Lean Test
3.1.5 mechanical pressure, n—the force exerted by one
involves the application of synthetic blood to an ink pad,
solid object upon another that it is touching. (1)
placement of sample fabric over the blood soaked pad, place-
ment of a blotter over the sample fabric, and applying elbow or
fingertip pressure on top of the blotter. The blotter is then
6 examined for staining as evidence of blood penetration. This
Annual Book of ASTM Standards, Vol. 15.09
Annual Book of ASTM Standards, Vol. 11.03 test method provides similar procedures which standardize the
Available from American Society for Quality Control, 611 E. Wisconsin Ave.,
test equipment and application of pressure through an adopted
Milwaukee, WI 53202.
methodology.
Available from American National Standards Institute, 11 W. 42nd St., 13th
5.2 This test method is intended to simulate actual use
Floor, New York, NY 10036.
Available from Standardization Documents Order Desk, Bldg. 4, Section D,
conditions wherein areas of the health care worker’s protective
700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
clothing are soaked with blood and compressed between the
Available from Supt. of Documents, U.S. Government Printing Office,
Washington, DC 20402.
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.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F1819–98
patient’s body and that of the health care worker, or similarly dation. Some studies suggest that mechanical pressures ex-
ceeding 345 kPa (50 psig) can occur during clinical use (8,9).
between the health care worker and instruments. In both cases,
unconfined blood moves away from the pressure point taking
NOTE 1—The mechanical pressure tester can be adjusted to evaluate
the path of least resistance rather than being contained as in
materials at higher pressures.
Test Methods F 1670 and F 1671.
5.10 Testing prior to degradation by physical, chemical, and
5.3 This test method uses predominately mechanical pres-
thermal stresses which could negatively impact the perfor-
sure as opposed to contained, hydrostatic pressure to demon-
mance of the protective barrier, could lead to a false sense of
strate liquid penetration resistance (1,2). It simulates actual use
security. Consider tests which assess the impact of storage
conditions with a single insult where free flowing liquids on the
conditions and shelf life for disposable products, and the
outer surfaces of a protective clothing item are momentarily
effects of laundering and sterilization for reusable products.
pressurized against the item by the body and other objects.
The integrity of the protective clothing can also be compro-
5.4 Because this test method provides quantitative results, it
mised during use by such effects as flexing and abrasion (10).
is useful for discriminating differences in the liquid barrier
It is also possible that prewetting by contaminants such as
performance of protective clothing materials. This test method
alcohol and perspiration can compromise the integrity of the
can be used for measuring differences in the penetration
protective clothing. Furthermore, high relative humidity may
pressure for protective clothing materials which do not pass
also affect the resistance of materials used in protective
Test Method F 1670.
clothing to penetration by blood and other body fluids. If these
conditions are of concern, evaluate the performance of protec-
5.5 This test method is normally used to evaluate specimens
tive clothing for synthetic blood penetration following an
from individual finished items of protective clothing and
appropriate pretreatment technique representative of the ex-
individual samples of materials that are candidates for items of
pected conditions of use.
protective clothing.
5.11 This test method involves a quantitative determination
5.5.1 Finished items of protective clothing include gloves,
of a protective clothing penetration resistance to synthetic
arm shields, aprons, gowns, hoods, and boots.
blood under specific test conditions. It can also be used as a
5.5.2 The phrase specimens from finished items encom-
qualitative method for comparing the penetration resistance
passes seamed and other discontinuous regions as well as the
characteristics of similar materials and as a material quality
usual continuous regions of protective clothing items.
control or assurance procedure.
5.6 Medical protective clothing materials are intended to be
5.12 If this test method is used for quality control, perform
a barrier to blood, body fluids, and other potentially infectious
proper statistical design and analysis of larger data sets where
materials. Many factors can affect the wetting and penetration
more than three specimens are tested. This type of analysis
characteristics of body fluids, such as surface tension, viscos-
includes, but is not limited to, reporting the number of
ity, and polarity of the fluid, as well as the structure and relative
individual specimens tested and the average penetration pres-
hydrophilicity or hydrophobicity of the materials. The surface
sure of specimens with a standard deviation. Data reported in
tension range for blood and body fluids (excluding saliva) is
this way helps establish confidence limits concerning product
approximately 0.042 to 0.060 N/m (3). To help simulate the
performance. Examples of acceptable sampling plans are found
wetting characteristics of blood and body fluids, the surface
in references such as MIL-STD-105, ANSI/ASQC Z1.4, and
tension of the synthetic blood is adjusted to approximate the
ISO 2859–1.
lower end of this surface tension range. The resulting surface
5.13 In the case of a dispute arising from differences in
tension of the synthetic blood is 0.042 6 0.002 N/m.
reported results when using this test method for acceptance
5.7 The synthetic blood mixture is prepared with a red dye
testing of commercial shipments, the purchaser and the sup-
to aid in visual detection and a thickening agent to simulate the
plier should conduct comparativ
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