ASTM F1671-97b

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.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.
Designation: F 1671 – 97b
Standard 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
This standard is issued under the fixed designation F 1671; 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)]. 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 assess
the effectiveness of materials used in protective clothing for protecting the wearer against contact with
blood-borne pathogens using a surrogate microbe suspended in a body fluid simulant under conditions
of continuous contact.
1. Scope seams) used in protective clothing and determined to be viral
resistant. This test method does not address the design, overall
1.1 This test method is used to measure the resistance of
construction and components, or interfaces of garments or
materials used in protective clothing to penetration by blood-
other factors which may affect the overall protection offered by
borne pathogens using a surrogate microbe under conditions of
the protective clothing.
continuous liquid contact. Protective clothing material pass/fail
1.5 The values stated in SI units or in other units shall be
determinations are based on the detection of viral penetration.
regarded separately as standard. The values stated in each
1.1.1 This test method is not always effective in testing
system must be used independently of the other, without
protective clothing materials having thick, inner liners which
combining values in any way.
readily absorb the liquid assay fluid.
1.6 This standard does not purport to address all of the
1.2 This test method does not apply to all forms or condi-
safety concerns, if any, associated with its use. It is the
tions of blood-borne pathogen exposure. Users of the test
responsibility of the user of this standard to establish appro-
method should review modes for worker/clothing exposure and
priate safety and health practices and determine the applica-
assess the appropriateness of this test method for their specific
bility of regulatory limitations prior to use.
applications.
1.3 This test method has been specifically defined for
2. Referenced Documents
modeling the viral penetration of Hepatitis (B and C) and
2.1 ASTM Standards:
Human Immunodeficiency Viruses transmitted in blood and
D 1331 Test Methods for Surface and Interfacial Tension of
other potentially infectious body fluids. Inferences for protec-
Solutions of Surface Active Agents
tion from other pathogens must be assessed on a case-by-case
D 1777 Method for Measuring Thickness of Textile Mate-
basis.
rials
1.4 This test method addresses only the performance of
D 3776 Test Method for Mass Per Unit Area (Weight) of
materials or certain material constructions (for example,
Fabric
D 3862 Test Method for Retention Characteristics of 0.2 μm
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
Biological Hazards. Annual Book of ASTM Standards, Vol 15.04.
Current edition approved Dec. 10, 1997. Published February 1998. Originally Annual Book of ASTM Standards, Vol 07.01.
published as F 1671 – 95 (formerly ES – 22). Last previous edition F 1671 – 97a. Annual Book of ASTM Standards, Vol 07.02.
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.
F 1671 – 97b
Membrane Filters Used in Routine Filtration Procedures 3.1.6.1 Discussion—For the purpose of this test method, the
for the Evaluation of Microbiological Water Quality primary blood-borne pathogens include Hepatitis B Virus
E 105 Practice for Probability Sampling of Materials (HBV), Hepatitis C Virus (HCV), and Human Immunodefi-
E 171 Specification for Standard Atmospheres for Condi- ciency Virus (HIV). Other microorganisms must be considered
tioning and Testing Flexible Barrier Materials on a case-by-case basis.
F 903 Test Method for Resistance of Materials Used in
3.1.7 body fluid, n—any liquid produced, secreted, or ex-
Protective Clothing to Penetration by Liquids creted by the human body.
F 1670 Test Method for Resistance of Materials Used in
3.1.7.1 Discussion—In this test method, body fluids include
Protective Clothing to Penetration by Synthetic Blood
those liquids potentially infected with blood-borne pathogens,
2.2 Military Standard:
including, but not limited to, blood, semen, vaginal secretions,
MIL-STD-105 Sampling Procedures and Tables for Inspec-
cerebrospinal fluid, synovial fluid, peritoneal fluid, amniotic
tion by Attributes
fluid, saliva in dental procedures, any body fluid that is visibly
2.3 ANSI/ASQC Standard:
contaminated with blood, and all body fluids in situations
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
where it is difficult or impossible to differentiate between body
Inspection by Attributes
fluids (see section 29 CFR Part 1910.1030).
2.4 ISO Standard:
3.1.8 body fluid simulant, n—a liquid which is used to act as
11 12
ISO 2859-1 Sampling Plans for Inspection by Attributes
a model for human body liquids.
2.5 OSHA Standard:
3.1.8.1 Discussion—In this test method, the body fluid
29 CFR Part 1910.1030 “Occupational Exposure to Blood-
simulant is bacteriophage nutrient broth, which is intended as
borne Pathogens: Final Rule,” Federal Register, Vol 56,
a model for human body liquids as it approximates the lower
No. 235, Dec. 6, 1991, pp. 64175-64182.
end of the surface tension range for blood and body fluids
(excluding saliva), 0.042 6 0.002 N/m.
3. Terminology
3.1.9 challenge suspension, n—a liquid containing an agent
3.1 Definitions:
that is used to test the penetration resistance of materials.
3.1.1 agar, n—a semisolid culture medium used to support
3.1.9.1 Discussion—In this test method, the challenge sus-
the growth of bacteria and other micro-organisms.
pension is the bacteriophage challenge suspension; a nutrient
3.1.2 aseptic, adj—sterile, free from viable microbiological
broth containing the Phi-X174 Bacteriophage.
contamination.
3.1.10 lawn, n—as in microbiology, a cloudy, uniform
3.1.3 assay, n—analysis of a mixture to determine the
growth of bacteria in a thin layer of top agar in a petri dish.
presence or concentration of a particular component.
3.1.10.1 Discussion—In this test method, E. coli C. has
3.1.3.1 Discussion—In this test method, the component
been selected as the bacterium used to produce the lawn.
being analyzed is a microorganism, Phi-X174 Bacteriophage.
3.1.11 lysis, n—the disintegration or destruction of whole
3.1.4 assay fluid, n—a sterile liquid used to wash the test
bacterial cells.
specimen surface to determine microbiological penetration.
3.1.11.1 Discussion—In this test method, the lysis of the
3.1.4.1 Discussion—In this test method, the assay fluid is
host bacteria, E. coli C., is caused by Phi-X174 Bacteriophage.
bacteriophage nutrient broth and the microorganism is the
3.1.12 medium (plural, media), n—a nutrient system for the
Phi-X174 Bacteriophage. The assay fluid is used to wash the
cultivation of cells or organisms, and especially bacteria.
Phi-X174 Bacteriophage from the normal inside surface of the
3.1.12.1 Discussion—In this test method, the term media is
test specimen.
used to describe mixtures compounded to support the growth
3.1.5 bacteriophage, n—a type of virus which infects bac-
of specific microorganisms; for example, bacteriophage nutri-
teria.
ent broth, top agar.
3.1.5.1 Discussion—In this test method, the bacteriophage
3.1.13 morphology, n—the form and structure of a particu-
is Phi-X174. The Phi-X174 Bacteriophage is not pathogenic to
lar organism.
humans, but serves to simulate viruses that are pathogenic to
3.1.14 nutrient broth, n—a liquid medium.
humans.
3.1.14.1 Discussion—In this test method, the nutrient broth
3.1.6 blood-borne pathogen, n—an infectious bacterium or
is the bacteriophage nutrient broth which is used to culture the
virus, or other disease inducing microbe carried in blood or
host bacteria, E. coli C., and to aid in manipulating the
other potentially infectious body fluids.
Phi-X174 Bacteriophage through the various stages of the
procedure, such as; suspending the Phi-X174 Bacteriophage
Annual Book of ASTM Standards, Vol 11.02.
6 for challenging the test material in the penetration cell,
Annual Book of ASTM Standards, Vol 14.02.
assaying the normal inside test material surface and, if re-
Annual Book of ASTM Standards, Vol 15.09.
Annual Book of ASTM Standards, Vol 11.03.
quired, making dilutions of the assay fluid for plating.
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
3.1.15 penetration, n—the flow of a liquid through closures,
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
porous materials, seams, and pinholes or other imperfections in
Available from American Society for Quality Control, 611 E. Wisconsin Ave.,
Milwaukee, WI 53202.
a protective clothing material on a nonmolecular level.
Available from American National Standards Institute, 11 W. 42nd St., 13th
3.1.16 plaque, n—as in virology, a visible, clear area, which
Floor, New York, NY 10036.
12 is theoretically the result of the infection and lysis of host cells
Available from Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. by a single viable virus.
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.
F 1671 – 97b
TABLE 1 Specimen Exposure Procedures
3.1.16.1 Discussion—In this test method, the term plaque is
used to describe a visible, clear area, in the lawn of E. coli C. Procedure Pressure/Time Sequence and Retaining Screen Options
in top agar, which is theoretically the result of a single viable
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.
Phi-X174, where the bacteria have been destroyed by bacte-
A retaining screen is not used to support the specimen.
riophage infection and lysis.
B 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 psig) for
3.1.17 plaque forming unit (PFU), n—a virus particle ca-
1 min, followed by 0 kPa (0 psig) for 54 min.
A retaining screen is used to support the specimen. The
pable of producing plaques by infecting and lysing bacteria in
type must be specified.
a lawn in top agar.
3.1.18 plate, n—as in microbiology, a Petri dish containing
culture medium.
3.1.19 protective clothing, n—apparel used for the purpose
clothing and individual samples of materials that are candidates
of protecting parts of the body from contact with a potential
for items of protective clothing.
hazard.
5.1.1 Finished items of protective clothing include gloves,
3.1.19.1 Discussion—In this test method, materials used in
arm shields, aprons, gowns, coveralls, hoods, and boots.
protective clothing are being evaluated. The potential hazard of
5.1.2 The phrase “specimens from finished items” encom-
contact with blood-borne pathogens is being simulated.
passes seamed and other discontinuous regions, as well as the
3.1.20 sterile, adj—free from viable microorganisms.
usual continuous regions of protective clothing items.
3.1.21 surrogate microbe, n—a microorganism which is
5.2 It is known that body fluids penetrating protective
used to act as a simulant for other microorganisms which are
clothing materials are likely to carry microbiological contami-
pathogenic to humans.
nants; however, visual detection methods are not sensitive
3.1.21.1 Discussion—In this test method, the surrogate
enough to detect minute amounts of liquid containing micro-
microbe is the Phi-X174 Bacteriophage, intended as a model 13
organisms (1,2,3). This test method uses media containing
for HCV and to simulate both HBV and HIV.
Phi-X174 Bacteriophage. The visual detection technique of
3.1.22 titer, n—the quantity of a substance required to react
this test method is supplemented with a biologically based
with, or to correspond to, a given amount of another substance.
assay capable of detecting virus under the specified test
3.1.22.1 Discussion—In this test method, titer is used to
conditions.
describe the concentration of viable bacteriophage as measured
5.3 Test Method F 1670, allows the screening of protective
in plaque forming units per millilitre (PFU/mL).
clothing materials for resistance to penetration with synthetic
3.1.23 viral penetration, n—the penetration of a material by
blood as a challenge liquid. Test Method F 1670 uses the same
a virus.
penetration test cell and technique, but exposes material
3.1.23.1 Discussion—In this test method, viral penetration
specimens to synthetic blood with visual detection of liquid
is used to describe the physical translocation of the Phi-X174
penetration. Materials passing Test Method F 1670 should then
Bacteriophage through closures, seams, pores, and pinholes or
be tested against bacteriophage penetration using this test
other imperfections in materials used in protective clothing.
method to verify performance.
3.1.24 viral resistant, adj—referring to materials which
5.4 This test method has been specifically designed for
impede viral penetration under specified laboratory test condi-
measuring penetration of a surrogate microbe for Hepatitis (B
tions and detection methods.
and C) and the Human Immunodeficiency Viruses. The surro-
3.1.24.1 Discussion—In this test method, protective cloth-
gate, Phi-X174 Bacteriophage, used in this test method is
ing materials which demonstrate pass results are consider
...