ASTM F1670/F1670M-08(2014)e1
(Test Method)Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
SIGNIFICANCE AND USE
5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.
5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.
5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual continuous regions of protective clothing items.
5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can 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. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (1) .7 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 approximately 0.042 ± 0.002 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.
5.4 Part of the protocol in Procedure A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurization of the test cell to 13.8 kPa [2 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and correlate with visual penetration results that are obtained with a human factors validation (2). Some studies, however, sug...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood.
1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671.
1.3 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.
1.4 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 and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.
1.5 The values stated in either 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 non-conformance with the standard.
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.
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´1
Designation: F1670/F1670M − 08 (Reapproved 2014)
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood
ThisstandardisissuedunderthefixeddesignationF1670/F1670M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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.
ε NOTE—Units information was editorially corrected in June 2014.
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, Hepatitis [Hepatitis B Virus (HBV) and Hepatitis C
Virus (HCV)] and Acquired Immune Deficiency Syndrome (AIDS) [Human Immunodeficiency
Viruses(HIV)].Sinceengineeringcontrolscannoteliminateallpossibleexposures,attentionisplaced
on reducing the potential of 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
identify protective clothing material candidates for further testing according to a more rigorous
procedure involving a surrogate for blood-borne pathogens.
1. Scope seams) used in protective clothing. This test method does not
address the design, overall construction and components, or
1.1 This test method is used to evaluate the resistance of
interfaces of garments, or other factors which may affect the
materialsusedinprotectiveclothingtopenetrationbysynthetic
overall protection offered by the protective clothing.
blood under conditions of continuous liquid contact. Protective
clothing pass/fail determinations are based on visual detection 1.5 The values stated in either SI units or inch-pound units
of synthetic blood penetration. are to be regarded separately as standard. The values stated in
1.1.1 This test method is not always effective in testing each system may not be exact equivalents; therefore, each
protective clothing materials having thick, inner liners which system shall be used independently of the other. Combining
readily absorb the synthetic blood. values from the two systems may result in non-conformance
with the standard.
1.2 This test method is a means for selecting protective
1.6 This standard does not purport to address all of the
clothing materials for subsequent testing with a more sophis-
safety concerns, if any, associated with its use. It is the
ticated barrier test as described in Test Method F1671.
responsibility of the user of this standard to establish appro-
1.3 This test method does not apply to all forms or condi-
priate safety and health practices and determine the applica-
tions of blood-borne pathogen exposure. Users of the test
bility of regulatory limitations prior to use.
method must review modes for work/clothing exposure and
assess the appropriateness of this test method for their specific
2. Referenced Documents
application.
2.1 ASTM Standards:
1.4 This test method addresses only the performance of
D1331 Test Methods for Surface and Interfacial Tension of
materials or certain material constructions (for example,
Solutions of Paints, Solvents, Solutions of Surface-Active
Agents, and Related Materials
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 June 15, 2014. Published June 2014. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1995. Last previous edition approved in 2008 as F1670 – 08. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1670_F1670M-08R14E01. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F1670/F1670M − 08 (2014)
D1777 Test Method for Thickness of Textile Materials 3.5 protective clothing, n—an item of clothing that is
D3776 Test Methods for Mass Per Unit Area (Weight) of specifically designed and constructed for the intended purpose
Fabric of isolating all or part of the body from a potential hazard; or,
E105 Practice for Probability Sampling of Materials isolating the external environment from contamination by the
E171 Practice for Conditioning and Testing Flexible Barrier wearer of the clothing.
Packaging 3.5.1 Discussion—The potential hazard is contact with
F903 Test Method for Resistance of Materials Used in blood.
Protective Clothing to Penetration by Liquids
3.6 synthetic blood, n—a mixture of a red dye/surfactant,
F1671 Test Method for Resistance of Materials Used in
thickening agent, and distilled water having a surface tension
Protective Clothing to Penetration by Blood-Borne Patho-
and viscosity representative of blood and some other body
gens Using Phi-X174 Bacteriophage Penetration as a Test
fluids, and the color of blood.
System
3.6.1 Discussion—The synthetic blood in this test method
2.2 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.
2.3 ANSI/ASQC Standards:
4. Summary of Test Method
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
spection by Attributes
4.1 A specimen is subjected to a body fluid simulant
2.4 ISO Standard:
(synthetic blood) for a specified time and pressure.
ISO 2859-1 Sampling Plans for Inspection by Attributes
4.2 Visual observation is made to determine when, or if,
2.5 OSHA Standard:
penetration occurs.
29 CFR Part 1910.1030 Occupational Exposure to Blood-
4.3 Any evidence of synthetic blood penetration constitutes
bornePathogens:FinalRule, Federal Register,Vol56,No
failure. Results are reported as pass/fail.
235, Dec. 6, 1991, pp. 6175–64182.
5. Significance and Use
3. Terminology
5.1 This test method is based on Test Method F903 for
3.1 blood-borne pathogen, n—an infectious secreted or
measuring resistance of chemical protective clothing materials
excreted bacterium, virus, or other disease inducing microbe
to penetration by liquids. This test method is normally used to
carried in blood or other body fluids.
evaluatespecimensfromindividualfinisheditemsofprotective
3.2 body fluid, n—anyliquidproduced,secreted,orexcreted
clothingandindividualsamplesofmaterialsthatarecandidates
by the human body.
for items of protective clothing.
3.2.1 Discussion—In this test method, body fluids include
5.1.1 Finished items of protective clothing include gloves,
those liquids potentially infected with blood-borne pathogens,
arm shields, aprons, gowns, coveralls, hoods, and boots.
including, but not limited to, blood, semen, vaginal secretions,
5.1.2 The phrase “specimens from finished items” encom-
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
passes seamed and other discontinuous regions as well as the
otic fluid, saliva in dental procedures, and any body fluid that
usual continuous regions of protective clothing items.
is visibly contaminated with blood, and all body fluids in
5.2 Medical protective clothing materials are intended to be
situations where it is difficult or impossible to differentiate
a barrier to blood, body fluids, and other potentially infectious
between body fluids.
materials. Many factors can affect the wetting and penetration
3.3 body fluid simulant, n—a liquid which is used to act as
characteristics of body fluids, such as surface tension,
a model for human body fluids.
viscosity, and polarity of the fluid, as well as the structure and
3.3.1 Discussion—In this test method, synthetic blood is
relative hydrophilicity or hydrophobicity of the materials. The
used as a body fluid simulant.
surface tension range for blood and body fluids (excluding
3.4 penetration, n—the movement of matter through
saliva) is approximately 0.042 to 0.060 N/m (1). To help
closures, porous materials, seams, and pinholes or other
simulate the wetting characteristics of blood and body fluids,
imperfections in protective clothing on a nonmolecular level.
the surface tension of the synthetic blood is adjusted to
3.4.1 Discussion—For this test method, the specific matter
approximate the lower end of this surface tension range. The
is synthetic blood.
resulting surface tension of the synthetic blood is approxi-
3.4.2 Discussion—In this test method, the penetration liquid
mately 0.042 6 0.002 N/m.
is synthetic blood.
5.3 The synthetic blood mixture is prepared with a red dye
to aid in visual detection and a thickening agent to simulate the
AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
flow characteristics of blood.
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Available from American Society for Quality Control, 611 E. Wisconsin Ave., 5.4 Part of the protocol in ProcedureAand B in Table 1 for
Milwaukee, WI 53202.
exposing the protective clothing material specimens with
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
6 7
Available from Supt. of Documents, U.S. Government Printing Office, The boldface numbers in parentheses refer to the list of references at the end of
Washington, DC 20402. this standard.
´1
F1670/F1670M − 08 (2014)
TABLE 1 Specimen Exposure Procedures
acceptable sampling plans are found in references such as
Procedure Pressure/Time Sequence and Retaining Screen Options MIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859-1.
A 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1
min, followed by 0 kPa [0 psig] for 54 min.
A retaining screen is not used to support the sample.
B 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1
min, followed by 0 kPa [0 psig] for 54 min.
A retaining screen is used to support the sample. The type
must be specified in the report.
synthetic blood involves pressurization of the test cell to 13.8
kPa [2 psig].This hydrostatic pressure has been documented to
discriminate between protective clothing material performance
and correlate with visual penetration results that are obtained
with a human factors validation (2). Some studies, however,
suggest that mechanical pressures exceeding 345 kPa [50 psig]
can occur during clinical use (3, 4). Therefore, it is important
to understand that this test method does not simulate all the
physical stresses and pressures that are exerted on protective
clothinggarmentsduringactualuse.Thistestmethodisoffered
to identify those protective clothing materials that warrant
further evaluation with a microbiological challenge.
5.5 Since this test method uses visual observation rather
than analytical measurements for determination of penetration,
use this test method as a preliminary evaluation for possible
penetrationofbloodandotherbodyfluids.Performsubsequent
testing with a microbiological challenge and analytical tech-
nique using Test Method F1671.
NOTE 1—No viral resistance claims can be made based on this test
method as materials can pass the test method and failTest Method F1671.
FIG. 1 Exploded View of the Penetration Test Cell with Retain-
ing Screen
5.6 Testing without considering degradation by physical,
chemical, and thermal stresses which could negatively impact
the performance of the protective barrier, could lead to a false
6. Apparatus
sense of security. Consider tests which assess the impact of
6.1 Thickness Gauge, suitable for measuring thickness to
storage conditions and shelf life for disposable products, and
the nearest 0.02 mm [or nearest 0.001 in.], in accordance with
theeffectsoflaunderingandsterilizationforreusableproducts.
Test Method D1777 (Optional).
Theintegrityoftheprotectivebarriercanalsobecompromised
9,10
6.2 Penetration Test Cell, torestrainthespecimenduring
during use by such effects as flexing and abrasion (5). It is also
contact with the pressurized test synthetic blood. In the test
possible that prewetting by contaminating materials such as
cell, the specimen acts as a partition separating synthetic blood
alcohol and perspiration can also compromise the integrity of
fromtheviewsideofthetestcell.Itconsistsofacellbodythat
the protective barrier. If these conditions are of concern,
is fastened to a cell support. The cell body has a capacity of
evaluate the performance of protective clothing materials for
approximately 60 mL [2.0 oz] for synthetic blood. A flange
synthetic blood penetration following an appropriate precon-
cover, with an open area to allow visual observation and a
ditioning technique representative of the expected conditions
transparent cover are included.The cell body has a top port for
of use.
filling and a drain valve for draining the penetration test cell.
5.7 While this test method involves a qualitative determi-
Other items, such as a fitting to allow attachment of the air line
nation of the protective clothing material resistance to penetra-
tothetopportinthecellbody,gaskets,andtheretainingscreen
tion by synthetic blood under specific test conditions, it is
possible to use this test method as a material quality control or
Thickness of each protective clothing material specimen tested may be
assurance procedure.
determinedpriortoperformingthetestprocedure,butisnotrequiredtocomplywith
5.7.1 If this procedure is used for quality control, perform
this test method. The thickness data for the material may be available from the
proper statistical design and analysis of the data, when more
manufacturer.
than three specimens are tested. This type of analysis includes,
The sole source of supply of the penetration test apparatus known to the
committee at this time is Wilson Road Machine Shop, 1170 Wilson Road, Rising
butisnotlimitedto,thenumberofindividualspecimenstested,
Sun, MD 21911.
the average percent passing or failing, or both, with a standard
If you are aware of alternative suppliers, please provide this information to
deviation. Data reported in this way helps to establish confi-
ASTM International Headquarters. Your comments will receive careful consider-
dence limits concerning prod
...
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.
´1
Designation: F1670 − 08 F1670/F1670M − 08 (Reapproved 2014)
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood
This standard is issued under the fixed designation F1670;F1670/F1670M; 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.
ε NOTE—Units information was editorially corrected in June 2014.
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, Hepatitis [Hepatitis B Virus (HBV) and Hepatitis C
Virus (HCV)] and Acquired Immune Deficiency Syndrome (AIDS) [Human Immunodeficiency
Viruses (HIV)]. Since engineering controls can not eliminate all possible exposures, attention is placed
on reducing the potential of 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
identify protective clothing material candidates for further testing according to a more rigorous
procedure involving a surrogate for blood-borne pathogens.
1. Scope
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood
under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of
synthetic blood penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily
absorb the synthetic blood.
1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated
barrier test as described in Test Method F1671.
1.3 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.
1.4 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 and components, or interfaces of
garments, or other factors which may affect the overall protection offered by the protective clothing.
1.5 The values stated in either SI units or otherinch-pound units shall are to be regarded separately as standard. The values stated
in each system must be may not be exact equivalents; therefore, each system shall be used independently of the other, without
combining values in any way.other. Combining values from the two systems may result in non-conformance with the standard.
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.
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 July 1, 2008June 15, 2014. Published September 2008June 2014. Originally approved in 1995. Last previous edition approved in 20072008 as
F1670 – 07.F1670 – 08. DOI: 10.1520/F1670-08.10.1520/F1670_F1670M-08R14E01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F1670/F1670M − 08 (2014)
2. Referenced Documents
2.1 ASTM Standards:
D1331 Test Methods for Surface and Interfacial Tension of Solutions of Surface-Active Agents
D1777 Test Method for Thickness of Textile Materials
D3776 Test Methods for Mass Per Unit Area (Weight) of Fabric
E105 Practice for Probability Sampling of Materials
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
F903 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
F1671 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
2.2 Military Standard:
MIL-STD-105 Sampling Procedures and Tables for Inspection by Attributes
2.3 ANSI/ASQC Standards:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
2.4 ISO Standard:
ISO 2859-1 Sampling Plans for Inspection by Attributes
2.5 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. 6175–64182.
3. Terminology
3.1 blood-borne pathogen, n—an infectious secreted or excreted bacterium, virus, or other disease inducing microbe carried in
blood or other body fluids.
3.2 body fluid, n—any liquid produced, secreted, or excreted by the human body.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Available from American Society for Quality Control, 611 E. Wisconsin Ave., Milwaukee, WI 53202.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Supt. of Documents, U.S. Government Printing Office, Washington, DC 20402.
3.2.1 Discussion—
In this test method, body fluids include those 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.
3.3 body fluid simulant, n—a liquid which is used to act as a model for human body fluids.
3.3.1 Discussion—
In this test method, synthetic blood is used as a body fluid simulant.
3.4 penetration, n—the movement of matter through closures, porous materials, seams, and pinholes or other imperfections in
protective clothing on a nonmolecular level.
3.4.1 Discussion—
For this test method, the specific matter is synthetic blood.
3.4.2 Discussion—
In this test method, the penetration liquid is synthetic blood.
3.5 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.
´1
F1670/F1670M − 08 (2014)
3.5.1 Discussion—
The potential hazard is contact with blood.
3.6 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.
3.6.1 Discussion—
TABLE 1 Specimen Exposure Procedures
Procedure Pressure/Time Sequence and Retaining Screen Options
A 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 psig) for 1
min, followed by 0 kPa (0 psig) for 54 min.
A 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1
min, followed by 0 kPa [0 psig] for 54 min.
A retaining screen is not used to support the sample.
B 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 psig) for 1
min, followed by 0 kPa (0 psig) for 54 min.
B 0 kPa [0 psig] for 5 min, followed by 13.8 kPa [2 psig] for 1
min, followed by 0 kPa [0 psig] for 54 min.
A retaining screen is used to support the sample. The type
must be specified in the report.
The synthetic blood in this test method does not simulate all of the characteristics of real blood or body fluids, for example, polarity
(a wetting characteristic), coagulation, content of cell matter.
4. Summary of Test Method
4.1 A specimen is subjected to a body fluid simulant (synthetic blood) for a specified time and pressure.
4.2 Visual observation is made to determine when, or if, penetration occurs.
4.3 Any evidence of synthetic blood penetration constitutes failure. Results are reported as pass/fail.
5. Significance and Use
5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to
penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective
clothing and individual samples of materials that are candidates for items of protective clothing.
5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.
5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual
continuous regions of protective clothing items.
5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious
materials. Many factors can 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. The surface tension
range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (1). 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 approximately 0.042 6 0.002 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.
5.4 Part of the protocol in Procedure A and B in Table 1 for exposing the protective clothing material specimens with synthetic
blood involves pressurization of the test cell to 13.8 kPa (2 psig).[2 psig]. This hydrostatic pressure has been documented to
discriminate between protective clothing material performance and correlate with visual penetration results that are obtained with
a human factors validation (2). Some studies, however, suggest that mechanical pressures exceeding 345 kPa (50 psig)[50 psig]
can occur during clinical use (3, 4). Therefore, it is important to understand that this test method does not simulate all the physical
stresses and pressures that are exerted on protective clothing garments during actual use. This test method is offered to identify
those protective clothing materials that warrant further evaluation with a microbiological challenge.
5.5 Since this test method uses visual observation rather than analytical measurements for determination of penetration, use this
test method as a preliminary evaluation for possible penetration of blood and other body fluids. Perform subsequent testing with
a microbiological challenge and analytical technique using Test Method F1671.
The boldface numbers in parentheses refer to the list of references at the end of this standard.
´1
F1670/F1670M − 08 (2014)
NOTE 1—No viral resistance claims can be made based on this test method as materials can pass the test method and fail Test Method F1671.
5.6 Testing without considering degradation by physical, chemical, and thermal stresses which could negatively impact the
performance of the protective 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 barrier can also be compromised during use by such effects as flexing and abrasion (5). It is also possible that
prewetting by contaminating materials such as alcohol and perspiration can also compromise the integrity of the protective barrier.
If these conditions are of concern, evaluate the performance of protective clothing materials for synthetic blood penetration
following an appropriate preconditioning technique representative of the expected conditions of use.
5.7 While this test method involves a qualitative determination of the protective clothing material 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.
5.7.1 If this procedure is used for quality control, perform proper statistical design and analysis of the data, when more than
three specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the
average percent passing and/or failing or failing, or both, with a standard deviation. Data reported in this way helps to establish
confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as
MIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859-1.
FIG. 1 Exploded View of the Penetration Test Cell with Retaining Screen
6. Apparatus
6.1 Thickness Gauge, suitable for measuring thickness to the nearest 0.02 mm (or[or nearest 0.001 in.),in.], in accordance with
Test Method D1777 (Optional).
9,10
6.2 Penetration Test Cell, to restrain the specimen during contact with the pressurized test synthetic blood. In the test cell,
the specimen acts as a partition separating synthetic blood from the view side of the test cell. It consists of a cell body that is
Thickness of each protective clothing material specimen tested may be determined prior to performing the test procedur
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