ASTM F1671/F1671M-22
(Test Method)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
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
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 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (1-3).7 This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method is supplemented with a biologically based assay capable of detecting virus under the specified test conditions.
5.3 Test Method F1670/F1670M allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670/F1670M uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials passing Test Method F1670/F1670M should then be tested against bacteriophage penetration using this test method to verify performance.
5.4 This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basi...
SCOPE
1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications.
1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis.
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. 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 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.
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This i...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1671/F1671M − 22
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Blood-Borne Pathogens Using Phi-X174
1
Bacteriophage Penetration as a Test System
ThisstandardisissuedunderthefixeddesignationF1671/F1671M;thenumberimmediatelyfollowingthedesignationindicatestheyear
of original adoption or, in the case of revision, the year of last revision.Anumber 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
individualsinjuredorsick,canbeexposedtobiologicalliquidscapableoftransmittingdisease.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 BVirus (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
theeffectivenessofmaterialsusedinprotectiveclothingforprotectingtheweareragainstcontactwith
blood-bornepathogensusingasurrogatemicrobesuspendedinabodyfluidsimulantunderconditions
of continuous contact.
1. Scope other potentially infectious body fluids. Inferences for protec-
tion from other pathogens must be assessed on a case-by-case
1.1 This test method is used to measure the resistance of
basis.
materials used in protective clothing to penetration by blood-
bornepathogensusingasurrogatemicrobeunderconditionsof
1.4 This test method addresses only the performance of
continuousliquidcontact.Protectiveclothingmaterialpass/fail
materials or certain material constructions (for example,
determinations are based on the detection of viral penetration.
seams) used in protective clothing and determined to be viral
1.1.1 This test method is not always effective in testing
resistant. This test method does not address the design, overall
protective clothing materials having thick, inner liners which
construction and components, or interfaces of garments or
readily absorb the liquid assay fluid.
otherfactorswhichmayaffecttheoverallprotectionofferedby
1.2 This test method does not apply to all forms or condi-
the protective clothing.
tions of blood-borne pathogen exposure. Users of the test
1.5 The values stated in SI units or in other units shall be
methodshouldreviewmodesforworker/clothingexposureand
regarded separately as standard. The values stated in each
assess the appropriateness of this test method for their specific
system must be used independently of the other, without
applications.
combining values in any way.
1.3 This test method has been specifically defined for
1.6 This standard does not purport to address all of the
modeling the viral penetration of Hepatitis (B and C) and
Human Immunodeficiency Viruses transmitted in blood and safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal
mine the applicability of regulatory limitations prior to use.
ProtectiveClothingandEquipmentandisthedirectresponsibilityofSubcommittee
F23.40 on Biological.
1.7 This international standard was developed in accor-
Current edition approved Jan. 1, 2022. Published January 2022. Originally
dance with internationally recognized principles on standard-
approved in 1995. Last previous edition approved in 2013 as F1671/F1671M–13.
DOI: 10.1520/F1671_F1671M-22. ization established in the Decision on Principles for the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1671/F1671M − 22
Development of International Standards, Guides and Recom- 3.1.4 assay fluid, n—a sterile liquid used to wash the test
mendations issued by the World Trade Organization Technical specimen surface to determine microbiological penetration.
Barriers to Trade (TBT) Committee.
3.1.4.1 Discussion—In this test method, the assay fluid is
bacteriophage nutrient broth and the microorganism is the
2. Referenced Documents
Phi-X174 Bacteriophage. The assay fluid is used to wash the
2
Phi-X174 Bacteriophage from the normal inside surface of
...
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.
Designation: F1671/F1671M − 13 F1671/F1671M − 22
Standard Test Method for
Resistance of Materials Used in Protective Clothing to
Penetration by Blood-Borne Pathogens Using Phi-X174
1
Bacteriophage Penetration as a Test System
This standard is issued under the fixed designation F1671/F1671M; 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
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
1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne
pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail
determinations are based on the detection of viral penetration.
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily
absorb the liquid assay fluid.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should
review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications.
1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human
Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other
pathogens must be assessed on a case-by-case basis.
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in
1
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 May 1, 2013Jan. 1, 2022. Published June 2013January 2022. Originally approved in 1995. Last previous edition approved in 20072013 as
F1671 – 07.F1671/F1671M – 13. DOI: 10.1520/F1671_F1671M-13.10.1520/F1671_F1671M-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1671/F1671M − 22
protective clothing and determined to be viral resistant. 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 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.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D1331 Test Method
...
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