ASTM F1670-98
(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
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 in SI units or 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.
1.6 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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Designation: F 1670 – 98
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Synthetic Blood
This standard is issued under the fixed designation F 1670; 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, 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 address the design, overall construction and components, or
interfaces of garments, or other factors which may affect the
1.1 This test method is used to evaluate the resistance of
overall protection offered by the protective clothing.
materials used in protective clothing to penetration by synthetic
1.5 The values in SI units or other units shall be regarded
blood under conditions of continuous liquid contact. Protective
separately as standard. The values stated in each system must
clothing pass/fail determinations are based on visual detection
be used independently of the other, without combining values
of synthetic blood penetration.
in any way.
1.1.1 This test method is not always effective in testing
1.6 This standard does not purport to address all of the
protective clothing materials having thick, inner liners which
safety concerns, if any, associated with its use. It is the
readily absorb the synthetic blood.
responsibility of the user of this standard to establish appro-
1.2 This test method is a means for selecting protective
priate safety and health practices and determine the applica-
clothing materials for subsequent testing with a more sophis-
bility of regulatory limitations prior to use.
ticated barrier test as described in Test Method F 1671.
1.3 This test method does not apply to all forms or condi-
2. Referenced Documents
tions of blood-borne pathogen exposure. Users of the test
2.1 ASTM Standards:
method must review modes for work/clothing exposure and
D 1331 Test Methods for Surface and Interfacial Tension of
assess the appropriateness of this test method for their specific
Solutions of Surface Active Agents
application.
D 1777 Test Method for Measuring Thickness of Textile
1.4 This test method addresses only the performance of
Materials
materials or certain material constructions (for example,
D 3776 Test Method for Mass Per Unit Area (Weight) of
seams) used in protective clothing. This test method does not
Woven Fabrics
This test method is under the jurisdiction of ASTM Committee F-23 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 Feb. 10, 1998. Published April 1998. Originally Annual Book of ASTM Standards, Vol 07.02.
published as ES – 21. Last previous edition F 1670 – 97.
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.
F1670–98
E 105 Practice for Probability Sampling of Materials 3.5.1 Discussion—The potential hazard is contact with
E 171 Specification for Standard Atmospheres for Condi- blood.
tioning and Testing Flexible Barrier Materials 3.6 synthetic blood, n—a mixture of a red dye/surfactant,
F 903 Test Method for Resistance of Materials Used in thickening agent, and distilled water having a surface tension
Protective Clothing to Penetration by Liquids and viscosity representative of blood and some other body
F 1671 Test Method for Resistance of Protective Clothing fluids, and the color of blood.
Materials to Penetration by Blood-Borne Pathogens Using 3.6.1 Discussion—The synthetic blood in this test method
Viral Penetration as a Test System does not simulate all of the characteristics of real blood or body
2.2 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
4. Summary of Test Method
2.3 ANSI/ASQC Standards:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
4.1 A specimen is subjected to a body fluid simulant
Inspection by Attributes
(synthetic blood) for a specified time and pressure.
2.4 ISO Standard:
4.2 Visual observation is made to determine when, or if,
ISO 2859-1 Sampling Plans for Inspection by Attributes
penetration occurs.
2.5 OSHA Standard:
4.3 Any evidence of synthetic blood penetration constitutes
29 CFR Part 1910.1030 Occupational Exposure to Blood-
failure. Results are reported as pass/fail.
borne Pathogens: Final Rule, Federal Register, Vol 56, No
235, Dec. 6, 1991, pp. 6175–64182.
TABLE 1 Specimen Exposure Procedures
Procedure Pressure/Time Sequence and Retaining Screen Options
3. Terminology
A 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 psig) for 1
3.1 blood-borne pathogen, n—an infectious secreted or
min, followed by 0 kPa (0 psig) for 54 min.
excreted bacterium, virus, or other disease inducing microbe 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
carried in blood or other body fluids.
min, followed by 0 kPa (0 psig) for 54 min.
3.2 body fluid, n—any liquid produced (secreted or ex-
A retaining screen is used to support the sample. The type
must be specified in the report.
creted) by the human body.
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,
5. Significance and Use
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
5.1 This test method is based on Test Method F 903 for
otic fluid, saliva in dental procedures, and any body fluid that
measuring resistance of chemical protective clothing materials
is visibly contaminated with blood, and all body fluids in
to penetration by liquids. This test method is normally used to
situations where it is difficult or impossible to differentiate
11 evaluate specimens from individual finished items of protective
between body fluids.
clothing and individual samples of materials that are candidates
3.3 body fluid simulant, n—a liquid which is used to act as
for items of protective clothing.
a model for human body fluids.
5.1.1 Finished items of protective clothing include gloves,
3.3.1 Discussion—In this test method, synthetic blood is
arm shields, aprons, gowns, coveralls, hoods, and boots.
used as a body fluid simulant.
5.1.2 The phrase “specimens from finished items” encom-
3.4 penetration, n—the flow of a liquid through closures,
passes seamed and other discontinuous regions as well as the
porous material, seams and pinholes or other imperfections in
usual continuous regions of protective clothing items.
a protective clothing material on a non-molecular level.
5.2 Medical protective clothing materials are intended to be
3.4.1 Discussion—In this test method, the penetration liquid
a barrier to blood, body fluids, and other potentially infectious
is synthetic blood.
materials. Many factors can affect the wetting and penetration
3.5 protective clothing, n—any material or combination of
characteristics of body fluids, such as surface tension, viscos-
materials used in an item of clothing for the purpose of
ity, and polarity of the fluid, as well as the structure and relative
isolating parts of the body from a potential hazard.
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
Annual Book of ASTM Standards, Vol 14.02.
Annual Book of ASTM Standards, Vol 15.09.
tension of the synthetic blood is adjusted to approximate the
Annual Book of ASTM Standards, Vol 11.03.
lower end of this surface tension range. The resulting surface
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
tension of the synthetic blood is approximately 0.042 6 0.002
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Available from American Society for Quality Control, 611 E. Wisconsin Ave., N/m.
Milwaukee, WI 53202.
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
11 12
Available from Supt. of Documents, U.S. Government Printing Office, The boldface numbers in parentheses refer to the list of references at the end
Washington, DC 20402. of this standard.
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.
F1670–98
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,
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
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 tech-
nique using Test Method F 1671.
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 F 1671.
5.6 Testing without considering degradation by physical,
FIG. 1 Exploded View of the Penetration Test Cell with
chemical, and thermal stresses which could negatively impact
Retaining Screen
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
Method D 1777, used to determine the thickness of each
the effects of laundering and sterilization for reusable products.
protective clothing material specimen tested.
The integrity of the protective barrier can also be compromised
6.2 Penetration Test Cell, to restrain the specimen during
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
from the view side of the test cell. It consists of a cell body that
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-
to the top port in the cell body, gaskets, and the retaining screen
tion by synthetic blood under specific test conditions, it is
are also required. Specifications for the penetration test cell are
possible to use this test method as a material quality control or
provided in Test Method F 903. A diagram of the test cell and
assurance procedure.
apparatus are provided in Figs. 1 and 2, respectively.
5.7.1 If this procedure is used for quality control, perform
6.3 Retaining Screen, a smooth finish plastic or metal
proper statistical design and analysis of the data, when more
square mesh screen meeting the following specifications used
than three specimens are tested. This type of analysis includes,
for Procedure B from Table 1:
but is not limited to, the number of individual specimens tested,
% open area >50
the average percent passing and/or failing with a standard
Should limit deflection of sample to <= 5.0 mm (0.2 in.)
deviation. Data reported in this way helps to establish confi-
dence 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.
The penetration test apparatus is available from Wilson Road Machine Shop,
1170 Wilson Road, Rising Sun, MD 21911.
Acceptable retaining screen materials are 11 by 11 nylon screen (No.
6. App
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