ASTM F1671 F1671M-2013 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration.pdf

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1、Designation: F1671 07F1671/F1671M 13Standard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Blood-Borne Pathogens Using Phi-X174Bacteriophage Penetration as a Test System1This standard is issued under the fixed designation F1671;F1671/F1671M; the number immediate

2、ly following the designation indicatesthe year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers,

3、primarily those in the health care profession, involved in treating and caring forindividuals injured or sick, can be exposed to biological liquids capable of transmitting disease. Thesediseases, which may be caused by a variety of microorganisms, can pose significant risks to life andhealth. This i

4、s especially true of blood-borne viruses which cause Hepatitis Hepatitis(Hepatitis BVirus (HBV) and Hepatitis C Virus (HCV)(HCV) and Acquired Immune Deficiency Syndrome(AIDS) Human(Human Immunodeficiency Virus (HIV).(HIV). Since engineering controls can noteliminate all possible exposures, attention

5、 is placed on reducing the potential of direct skin contactthrough the use of protective clothing that resists penetration (29 CFR Part 1910.1030). This testmethod was developed to assess the effectiveness of materials used in protective clothing forprotecting the wearer against contact with blood-b

6、orne pathogens using a surrogate microbesuspended in a body fluid simulant under conditions of continuous contact.1. Scope1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-bornepathogens using a surrogate microbe under conditions

7、of continuous liquid contact. Protective clothing material pass/faildeterminations 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 readilyabsorb the liquid assay fluid.1.2 This te

8、st method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test methodshould 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 mod

9、eling the viral penetration of Hepatitis (B and C) and HumanImmunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from otherpathogens must be assessed on a case-by-case basis.1.4 This test method addresses only the performance of materi

10、als or certain material constructions (for example, seams) usedin protective clothing and determined to be viral resistant. This test method does not address the design, overall construction andcomponents, or interfaces of garments or other factors which may affect the overall protection offered by

11、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 mustbe 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,

12、 if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective

13、Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Feb. 1, 2007May 1, 2013. Published February 2007June 2013. Originally approved in 1995. Last previous edition approved in 20032007 asF1671 03.F1671 07. DOI: 10.1520/F1671-07.10.1520/F

14、1671_F1671M-13.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. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users co

15、nsult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12. Referenced Documents2.1 ASTM S

16、tandards:2D1331 Test Methods for Surface and Interfacial Tension of Solutions of Surface-Active AgentsD1777 Test Method for Thickness of Textile MaterialsD3776 Test Methods for Mass Per Unit Area (Weight) of FabricD3862 Test Method for Retention Characteristics of 0.2-m Membrane Filters Used in Rout

17、ine Filtration Procedures for theEvaluation of Microbiological Water Quality (Withdrawn 2010)3E105 Practice for Probability Sampling of MaterialsE171 Practice for Conditioning and Testing Flexible Barrier PackagingF903 Test Method for Resistance of Materials Used in Protective Clothing to Penetratio

18、n by LiquidsF1670 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood2.2 Military Standard:MIL-STD-105 Sampling Procedures and Tables for Inspection by Attributes42.3 ANSI/ASQC Standard:ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by

19、Attributes52.4 ISO Standard:ISO 2859-1 Sampling Plans for Inspection by Attributes62.5 OSHA Standard:29 CFR Part 1910.1030 “Occupational Exposure to Bloodborne Pathogens: Final Rule,” Federal Register,Vol 56, No. 235, Dec.6, 1991, pp. 64175-64182.73. Terminology3.1 Definitions:3.1.1 agar, na semisol

20、id culture medium used to support the growth of bacteria and other micro-organisms.3.1.2 aseptic, adjsterile, free from viable microbiological contamination.3.1.3 assay, nanalysis of a mixture to determine the presence or concentration of a particular component.3.1.3.1 DiscussionIn this test method,

21、 the component being analyzed is a microorganism, Phi-X174 Bacteriophage.3.1.4 assay fluid, na sterile liquid used to wash the test specimen surface to determine microbiological penetration.3.1.4.1 DiscussionIn this test method, the assay fluid is bacteriophage nutrient broth and the microorganism i

22、s the Phi-X174 Bacteriophage. The assayfluid is used to wash the Phi-X174 Bacteriophage from the normal inside surface of the test specimen.3.1.5 bacteriophage, na type of virus which infects bacteria.3.1.5.1 DiscussionIn this test method, the bacteriophage is Phi-X174. The Phi-X174 Bacteriophage is

23、 not pathogenic to humans, but serves tosimulate viruses that are pathogenic to humans.3.1.6 blood-borne pathogen, nan infectious bacterium or virus, or other disease inducing microbe carried in blood or otherpotentially infectious body fluids.3.1.6.1 Discussion2 For referencedASTM standards, visit

24、theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.4 Available f

25、rom Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.19111-5098,http:/dodssp.daps.dla.mil.5 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.53203, http:/www.asq.org.6 Available

26、from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.10036, http:/www.ansi.org.7 Available from U.S. Government Printing Office Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.732 N. Capitol St., NW, MailStop: SDE, Washin

27、gton, DC 20401, http:/www.access.gpo.gov.F1671/F1671M 132For the purpose of this test method, the primary blood-borne pathogens include Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),and Human Immunodeficiency Virus (HIV). Other microorganisms must be considered on a case-by-case basis.3.1.7 body

28、fluid, nany liquid produced, secreted, or excreted by the human body.3.1.7.1 DiscussionIn this test method, body fluids include those liquids potentially infected with blood-borne pathogens, including, but not limitedto, blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, peritone

29、al fluid, amniotic fluid, saliva in dental procedures,any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible todifferentiate between body fluids (see section 29 CFR Part 1910.1030).3.1.8 body fluid simulant, na liquid which is us

30、ed to act as a model for human body liquids.3.1.8.1 DiscussionIn this test method, the body fluid simulant is bacteriophage nutrient broth, which is intended as a model for human body liquidsas it approximates the lower end of the surface tension range for blood and body fluids (excluding saliva), 0

31、.042 6 0.002 N/m.3.1.9 challenge suspension, na liquid containing an agent that is used to test the penetration resistance of materials.3.1.9.1 DiscussionIn this test method, the challenge suspension is the bacteriophage challenge suspension; a nutrient broth containing the Phi-X174Bacteriophage.3.1

32、.10 lawn, nas in microbiology, a cloudy, uniform growth of bacteria in a thin layer of top agar in a petri dish.3.1.10.1 DiscussionIn this test method, E. coli C. has been selected as the bacterium used to produce the lawn.3.1.11 lysis, nthe disintegration or destruction of whole bacterial cells.3.1

33、.11.1 DiscussionIn this test method, the lysis of the host bacteria, E. coli C., is caused by Phi-X174 Bacteriophage.3.1.12 medium (plural, media), na nutrient system for the cultivation of cells or organisms, and especially bacteria.3.1.12.1 DiscussionIn this test method, the term media is used to

34、describe mixtures compounded to support the growth of specific microorganisms;for example, bacteriophage nutrient broth, top agar.3.1.13 morphology, nthe form and structure of a particular organism.3.1.14 nutrient broth, na liquid medium.3.1.14.1 DiscussionIn this test method, the nutrient broth is

35、the bacteriophage nutrient broth which is used to culture the host bacteria, E. coli C., andto aid in manipulating the Phi-X174 Bacteriophage through the various stages of the procedure, such as; suspending the Phi-X174Bacteriophage for challenging the test material in the penetration cell, assaying

36、 the normal inside test material surface and, ifrequired, making dilutions of the assay fluid for plating.3.1.15 penetration, nthe movement of matter through closures, porous materials, seams, and pinholes or other imperfectionsin protective clothing on a nonmolecular level.3.1.15.1 DiscussionFor th

37、is test method, the specific matter is a bacteriophage challenge suspension containing nutrient broth with Phi-X174Bacteriophage.F1671/F1671M 1333.1.16 plaque, nas in virology, a visible, clear area, which is theoretically the result of the infection and lysis of host cells bya single viable virus.3

38、.1.16.1 DiscussionIn this test method, the term plaque is used to describe a visible, clear area, in the lawn of E. coli C. in top agar, which istheoretically the result of a single viable Phi-X174, where the bacteria have been destroyed by bacteriophage infection and lysis.3.1.17 plaque forming uni

39、t (PFU), na virus particle capable of producing plaques by infecting and lysing bacteria in a lawnin top agar.3.1.18 plate, nas in microbiology, a Petri dish containing culture medium.3.1.19 protective clothing, nan item of clothing that is specifically designed and constructed for the intended purp

40、ose ofisolating all or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearerof the clothing.3.1.19.1 DiscussionIn this test method, materials used in protective clothing are being evaluated. The potential hazard of contact with blood-bornep

41、athogens is being simulated.3.1.20 sterile, adjfree from viable microorganisms.3.1.21 surrogate microbe, na microorganism which is used to act as a simulant for other microorganisms which are pathogenicto humans.3.1.21.1 DiscussionIn this test method, the surrogate microbe is the Phi-X174 Bacterioph

42、age, intended as a model for HCV and to simulate both HBVand HIV.3.1.22 titer, nthe quantity of a substance required to react with, or to correspond to, a given amount of another substance.3.1.22.1 DiscussionIn this test method, titer is used to describe the concentration of viable bacteriophage as

43、measured in plaque forming units permillilitre (PFU/mL).3.1.23 viral penetration, nthe penetration of a material by a virus.3.1.23.1 DiscussionIn this test method, viral penetration is used to describe the physical translocation of the Phi-X174 Bacteriophage through closures,seams, pores, and pinhol

44、es or other imperfections in materials used in protective clothing.3.1.24 viral resistant, adjreferring to materials which impede viral penetration under specified laboratory test conditions anddetection methods.3.1.24.1 DiscussionIn this test method, protective clothing materials which demonstrate

45、pass results are considered to be resistant to viral penetration.3.1.25 virus, na minute infectious agent, which lacks independent metabolism and is only able to replicate within a living hostcell.4. Summary of Test Method4.1 A specimen is subjected to a nutrient broth containing a virus for a speci

46、fied time and pressure sequence.4.2 Visual detection of penetration is supplemented with an assay procedure that will detect viable viruses which penetrate thematerial even when liquid penetration is not visible. Any evidence of viral penetration for a test specimen constitutes failure.F1671/F1671M

47、1345. Significance and Use5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials topenetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protectiveclothing and individual samples

48、 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 u

49、sualcontinuous 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 (1,2,3).8This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method issupplemented with a biologically based assay capable of detecting virus under the specified test condition