1、Designation: F 1671 07Standard 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 F 1671; the number immediately following the designati
2、on indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers, primarily those in the he
3、alth 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 is especially true of bloo
4、d-borne viruses which cause Hepatitis Hepatitis B Virus (HBV)and Hepatitis C Virus (HCV) and Acquired Immune Deficiency Syndrome (AIDS) HumanImmunodeficiency Virus (HIV). Since engineering controls can not eliminate all possible exposures,attention is placed on reducing the potential of direct skin
5、contact through the use of protectiveclothing that resists penetration (29 CFR Part 1910.1030). This test method was developed to assessthe effectiveness of materials used in protective clothing for protecting the wearer against contact withblood-borne pathogens using a surrogate microbe suspended i
6、n a body fluid simulant under conditionsof continuous contact.1. Scope1.1 This test method is used to measure the resistance ofmaterials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions ofcontinuous liquid contact. Protective clothing mat
7、erial pass/faildeterminations are based on the detection of viral penetration.1.1.1 This test method is not always effective in testingprotective clothing materials having thick, inner liners whichreadily absorb the liquid assay fluid.1.2 This test method does not apply to all forms or condi-tions o
8、f blood-borne pathogen exposure. Users of the testmethod should review modes for worker/clothing exposure andassess the appropriateness of this test method for their specificapplications.1.3 This test method has been specifically defined formodeling the viral penetration of Hepatitis (B and C) andHu
9、man Immunodeficiency Viruses transmitted in blood andother potentially infectious body fluids. Inferences for protec-tion from other pathogens must be assessed on a case-by-casebasis.1.4 This test method addresses only the performance ofmaterials or certain material constructions (for example,seams)
10、 used in protective clothing and determined to be viralresistant. This test method does not address the design, overallconstruction and components, or interfaces of garments orother factors which may affect the overall protection offered bythe protective clothing.1.5 The values stated in SI units or
11、 in other units shall beregarded separately as standard. The values stated in eachsystem must be used independently of the other, withoutcombining values in any way.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of th
12、e user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 1331 Test Methods for Surface and Interfacial Tension ofSolutions of Surface-Active AgentsD 1777 Test Met
13、hod for Thickness of Textile MaterialsD 3776 Test Method for Mass Per Unit Area (Weight) ofFabricD 3862 Test Method for Retention Characteristics of1This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of Subcom
14、mitteeF23.40 on Biological.Current edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 1995. Last previous edition approved in 2003 as F 1671 03.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Ann
15、ual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.0.2-m Membrane Filters Used in Routine Filtration Pro-cedures for the Evalu
16、ation of Microbiological Water Qual-ityE 105 Practice for Probability Sampling Of MaterialsE 171 Specification for Atmospheres for Conditioning andTesting Flexible Barrier MaterialsF 903 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by LiquidsF 1670 Test Method fo
17、r Resistance of Materials Used inProtective Clothing to Penetration by Synthetic Blood2.2 Military Standard:MIL-STD-105 Sampling Procedures and Tables for Inspec-tion by Attributes32.3 ANSI/ASQC Standard:ANSI/ASQC Z1.4 Sampling Procedures and Tables forInspection by Attributes42.4 ISO Standard:ISO 2
18、859-1 Sampling Plans for Inspection by Attributes562.5 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. 64175-64182.3. Terminology3.1 Definitions:3.1.1 agar, na semisolid culture medium used to suppo
19、rtthe growth of bacteria and other micro-organisms.3.1.2 aseptic, adjsterile, free from viable microbiologicalcontamination.3.1.3 assay, nanalysis of a mixture to determine thepresence or concentration of a particular component.3.1.3.1 DiscussionIn this test method, the componentbeing analyzed is a
20、microorganism, Phi-X174 Bacteriophage.3.1.4 assay fluid, na sterile liquid used to wash the testspecimen surface to determine microbiological penetration.3.1.4.1 DiscussionIn this test method, the assay fluid isbacteriophage nutrient broth and the microorganism is thePhi-X174 Bacteriophage. The assa
21、y fluid is used to wash thePhi-X174 Bacteriophage from the normal inside surface of thetest specimen.3.1.5 bacteriophage, na type of virus which infects bac-teria.3.1.5.1 DiscussionIn this test method, the bacteriophageis Phi-X174. The Phi-X174 Bacteriophage is not pathogenic tohumans, but serves to
22、 simulate viruses that are pathogenic tohumans.3.1.6 blood-borne pathogen, nan infectious bacterium orvirus, or other disease inducing microbe carried in blood orother potentially infectious body fluids.3.1.6.1 DiscussionFor the purpose of this test method, theprimary blood-borne pathogens include H
23、epatitis B Virus(HBV), Hepatitis C Virus (HCV), and Human Immunodefi-ciency Virus (HIV). Other microorganisms must be consideredon a case-by-case basis.3.1.7 body fluid, nany liquid produced, secreted, or ex-creted by the human body.3.1.7.1 DiscussionIn this test method, body fluids includethose liq
24、uids potentially infected with blood-borne pathogens,including, but not limited to, blood, semen, vaginal secretions,cerebrospinal fluid, synovial fluid, peritoneal fluid, amnioticfluid, saliva in dental procedures, any body fluid that is visiblycontaminated with blood, and all body fluids in situat
25、ionswhere it is difficult or impossible to differentiate between bodyfluids (see section 29 CFR Part 1910.1030).3.1.8 body fluid simulant, na liquid which is used to act asa model for human body liquids.3.1.8.1 DiscussionIn this test method, the body fluidsimulant is bacteriophage nutrient broth, wh
26、ich is intended asa model for human body liquids as it approximates the lowerend of the surface tension range for blood and body fluids(excluding saliva), 0.042 6 0.002 N/m.3.1.9 challenge suspension, na liquid containing an agentthat is used to test the penetration resistance of materials.3.1.9.1 D
27、iscussionIn this test method, the challenge sus-pension is the bacteriophage challenge suspension; a nutrientbroth containing the Phi-X174 Bacteriophage.3.1.10 lawn, nas in microbiology, a cloudy, uniformgrowth of bacteria in a thin layer of top agar in a petri dish.3.1.10.1 DiscussionIn this test m
28、ethod, E. coli C. hasbeen selected as the bacterium used to produce the lawn.3.1.11 lysis, nthe disintegration or destruction of wholebacterial cells.3.1.11.1 DiscussionIn this test method, the lysis of thehost bacteria, E. coli C., is caused by Phi-X174 Bacteriophage.3.1.12 medium (plural, media),
29、na nutrient system for thecultivation of cells or organisms, and especially bacteria.3.1.12.1 DiscussionIn this test method, the term media isused to describe mixtures compounded to support the growthof specific microorganisms; for example, bacteriophage nutri-ent broth, top agar.3.1.13 morphology,
30、nthe form and structure of a particu-lar organism.3.1.14 nutrient broth, na liquid medium.3.1.14.1 DiscussionIn this test method, the nutrient brothis the bacteriophage nutrient broth which is used to culture thehost bacteria, E. coli C., and to aid in manipulating thePhi-X174 Bacteriophage through
31、the various stages of theprocedure, such as; suspending the Phi-X174 Bacteriophagefor challenging the test material in the penetration cell,assaying the normal inside test material surface and, if re-quired, making dilutions of the assay fluid for plating.3.1.15 penetration, nthe movement of matter
32、throughclosures, porous materials, seams, and pinholes or otherimperfections in protective clothing on a nonmolecular level.3.1.15.1 DiscussionFor this test method, the specific mat-ter is a bacteriophage challenge suspension containing nutrientbroth with Phi-X174 Bacteriophage.3Available from Stand
33、ardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New Yor
34、k, NY 10036.6Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.F16710723.1.16 plaque, nas in virology, a visible, clear area, whichis theoretically the result of the infection and lysis of host cellsby a single viable virus.3.1.16.1 DiscussionIn this te
35、st method, the term plaque isused to describe a visible, clear area, in the lawn of E. coli C.in top agar, which is theoretically the result of a single viablePhi-X174, where the bacteria have been destroyed by bacte-riophage infection and lysis.3.1.17 plaque forming unit (PFU), na virus particle ca
36、-pable of producing plaques by infecting and lysing bacteria ina lawn in top agar.3.1.18 plate, nas in microbiology, a Petri dish containingculture medium.3.1.19 protective clothing, nan item of clothing that isspecifically designed and constructed for the intended purposeof isolating all or part of
37、 the body from a potential hazard; or,isolating the external environment from contamination by thewearer of the clothing.3.1.19.1 DiscussionIn this test method, materials used inprotective clothing are being evaluated. The potential hazard ofcontact with blood-borne pathogens is being simulated.3.1.
38、20 sterile, adjfree from viable microorganisms.3.1.21 surrogate microbe, na microorganism which isused to act as a simulant for other microorganisms which arepathogenic to humans.3.1.21.1 DiscussionIn this test method, the surrogatemicrobe is the Phi-X174 Bacteriophage, intended as a modelfor HCV an
39、d to simulate both HBV and HIV.3.1.22 titer, nthe quantity of a substance required to reactwith, or to correspond to, a given amount of another substance.3.1.22.1 DiscussionIn this test method, titer is used todescribe the concentration of viable bacteriophage as measuredin plaque forming units per
40、millilitre (PFU/mL).3.1.23 viral penetration, nthe penetration of a material bya virus.3.1.23.1 DiscussionIn this test method, viral penetrationis used to describe the physical translocation of the Phi-X174Bacteriophage through closures, seams, pores, and pinholes orother imperfections in materials
41、used in protective clothing.3.1.24 viral resistant, adjreferring to materials whichimpede viral penetration under specified laboratory test condi-tions and detection methods.3.1.24.1 DiscussionIn this test method, protective cloth-ing materials which demonstrate pass results are considered tobe resi
42、stant to viral penetration.3.1.25 virus, na minute infectious agent, which lacksindependent metabolism and is only able to replicate within aliving host cell.4. Summary of Test Method4.1 A specimen is subjected to a nutrient broth containing avirus for a specified time and pressure sequence.4.2 Visu
43、al detection of penetration is supplemented with anassay procedure that will detect viable viruses which penetratethe material even when liquid penetration is not visible. Anyevidence of viral penetration for a test specimen constitutesfailure.5. Significance and Use5.1 This test method is based on
44、Test Method F 903 formeasuring resistance of chemical protective clothing materialsto penetration by liquids. This test method is normally used toevaluate specimens from individual finished items of protectiveclothing and individual samples of materials that are candidatesfor items of protective clo
45、thing.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” encom-passes seamed and other discontinuous regions, as well as theusual continuous regions of protective clothing items.5.2 It is
46、 known that body fluids penetrating protectiveclothing materials are likely to carry microbiological contami-nants; however, visual detection methods are not sensitiveenough to detect minute amounts of liquid containing micro-organisms (1,2,3).7This test method uses media containingPhi-X174 Bacterio
47、phage. The visual detection technique ofthis test method is supplemented with a biologically basedassay capable of detecting virus under the specified testconditions.5.3 Test Method F 1670, allows the screening of protectiveclothing materials for resistance to penetration with syntheticblood as a ch
48、allenge liquid. Test Method F 1670 uses the samepenetration test cell and technique, but exposes materialspecimens to synthetic blood with visual detection of liquidpenetration. Materials passing Test Method F 1670 should thenbe tested against bacteriophage penetration using this testmethod to verif
49、y performance.5.4 This test method has been specifically designed formeasuring penetration of a surrogate microbe for Hepatitis (Band C) and the Human Immunodeficiency Viruses. The surro-gate, Phi-X174 Bacteriophage, used in this test method issimilar to HCV in size and shape but also serves as a surrogatefor HBV and HIV. Inferences about protection from otherpathogens must be assessed on a case-by-case basis.5.5 Part of the protocol in Procedure A and B in Table 1, forexposing the protective clothing material specimens to thePhi-X174 Ba
