1、Designation: F 1670 08Standard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Synthetic Blood1This standard is issued under the fixed designation F 1670; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re
2、vision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers, primarily those in the health care profession, involved in treating and caring forindivid
3、uals 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 blood-borne, Hepatitis Hepatitis B Virus (HBV) and Hepatitis CVirus
4、(HCV) and Acquired Immune Deficiency Syndrome (AIDS) Human ImmunodeficiencyViruses (HIV). Since engineering controls can not eliminate all possible exposures, attention is placedon reducing the potential of direct skin contact through the use of protective clothing that resistspenetration (29 CFR Pa
5、rt 1910.1030). This test method was developed to help assess the effectivenessof materials used in protective clothing for protecting the wearer against contact with body fluids thatpotentially contain blood-borne pathogens. Using synthetic blood, this test method is intended toidentify protective c
6、lothing material candidates for further testing according to a more rigorousprocedure involving a surrogate for blood-borne pathogens.1. Scope1.1 This test method is used to evaluate the resistance ofmaterials used in protective clothing to penetration by syntheticblood under conditions of continuou
7、s liquid contact. Protectiveclothing pass/fail determinations are based on visual detectionof synthetic blood penetration.1.1.1 This test method is not always effective in testingprotective clothing materials having thick, inner liners whichreadily absorb the synthetic blood.1.2 This test method is
8、a means for selecting protectiveclothing materials for subsequent testing with a more sophis-ticated barrier test as described in Test Method F 1671.1.3 This test method does not apply to all forms or condi-tions of blood-borne pathogen exposure. Users of the testmethod must review modes for work/cl
9、othing exposure andassess the appropriateness of this test method for their specificapplication.1.4 This test method addresses only the performance ofmaterials or certain material constructions (for example,seams) used in protective clothing. This test method does notaddress the design, overall cons
10、truction and components, orinterfaces of garments, or other factors which may affect theoverall protection offered by the protective clothing.1.5 The values in SI units or other units shall be regardedseparately as standard. The values stated in each system mustbe used independently of the other, wi
11、thout combining valuesin 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 the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitat
12、ions 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 Method for Thickness of Textile MaterialsD 3776 Test Methods for Mass Per Unit Area (Weight) ofFabricE 105 Practice for Probability Sam
13、pling 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 1671 Test Method for Resistance of Materials Used in1This test method is under the jurisdict
14、ion ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved July 1, 2008. Published September 2008. Originallyapproved in 1995. Last previous edition approved in 2007 as F 1670 07.2For referenced
15、ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual 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 Consh
16、ohocken, PA 19428-2959, United States.Protective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2 Military Standard:3MIL-STD-105 Sampling Procedures and Tables for Inspec-tion by Attributes2.3 ANSI/ASQC Standards:4ANSI/ASQC Z1.4 Sampling P
17、rocedures and Tables forInspection by Attributes2.4 ISO Standard:5ISO 2859-1 Sampling Plans for Inspection by Attributes2.5 OSHA Standard:629 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol 56, No235, Dec. 6, 1991, pp. 617564182.3. Terminology3.1
18、blood-borne pathogen, nan infectious secreted orexcreted bacterium, virus, or other disease inducing microbecarried in blood or other body fluids.3.2 body fluid, nany liquid produced, secreted, or ex-creted by the human body.3.2.1 DiscussionIn this test method, body fluids includethose liquids poten
19、tially infected with blood-borne pathogens,including, but not limited to, blood, semen, vaginal secretions,cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-otic fluid, saliva in dental procedures, and any body fluid thatis visibly contaminated with blood, and all body fluids insituatio
20、ns where it is difficult or impossible to differentiatebetween body fluids.63.3 body fluid simulant, na liquid which is used to act asa model for human body fluids.3.3.1 DiscussionIn this test method, synthetic blood isused as a body fluid simulant.3.4 penetration, nthe movement of matter through cl
21、o-sures, porous materials, seams, and pinholes or other imper-fections in protective clothing on a nonmolecular level.3.4.1 DiscussionFor this test method, the specific matteris synthetic blood.3.4.2 DiscussionIn this test method, the penetration liquidis synthetic blood.3.5 protective clothing, nan
22、 item of clothing that isspecifically designed and constructed for the intended purposeof isolating all or part of the body from a potential hazard; or,isolating the external environment from contamination by thewearer of the clothing.3.5.1 DiscussionThe potential hazard is contact withblood.3.6 syn
23、thetic blood, na mixture of a red dye/surfactant,thickening agent, and distilled water having a surface tensionand viscosity representative of blood and some other bodyfluids, and the color of blood.3.6.1 DiscussionThe synthetic blood in this test methoddoes not simulate all of the characteristics o
24、f real blood or bodyfluids, for example, polarity (a wetting characteristic), coagu-lation, content of cell matter.4. Summary of Test Method4.1 A specimen is subjected to a body fluid simulant(synthetic blood) for a specified time and pressure.4.2 Visual observation is made to determine when, or if,
25、penetration occurs.4.3 Any evidence of synthetic blood penetration constitutesfailure. Results are reported as pass/fail.5. Significance and Use5.1 This test method is based on Test Method F 903 formeasuring resistance of chemical protective clothing materialsto penetration by liquids. This test met
26、hod is normally used toevaluate specimens from individual finished items of protectiveclothing and individual samples of materials that are candidatesfor items of protective clothing.5.1.1 Finished items of protective clothing include gloves,arm shields, aprons, gowns, coveralls, hoods, and boots.5.
27、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 Medical protective clothing materials are intended to bea barrier to blood, body fluids, and other potentially infectiousmaterial
28、s. Many factors can affect the wetting and penetrationcharacteristics of body fluids, such as surface tension, viscos-ity, and polarity of the fluid, as well as the structure and relativehydrophilicity or hydrophobicity of the materials. The surfacetension range for blood and body fluids (excluding
29、saliva) isapproximately 0.042 to 0.060 N/m (1).7To help simulate thewetting characteristics of blood and body fluids, the surfacetension of the synthetic blood is adjusted to approximate thelower end of this surface tension range. The resulting surfacetension of the synthetic blood is approximately
30、0.042 6 0.002N/m.5.3 The synthetic blood mixture is prepared with a red dyeto aid in visual detection and a thickening agent to simulate theflow characteristics of blood.5.4 Part of the protocol in Procedure A and B in Table 1 forexposing the protective clothing material specimens withsynthetic bloo
31、d involves pressurization of the test cell to 13.83Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.4Available from American Society for Quality Control, 611 E. Wisconsin Ave.,Milwaukee, WI 53202.5Available from America
32、n National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6Available from Supt. of Documents, U.S. Government Printing Office, Wash-ington, DC 20402.7The boldface numbers in parentheses refer to the list of references at the end ofthis standard.TABLE 1 S
33、pecimen Exposure ProceduresProcedure Pressure/Time Sequence and Retaining Screen OptionsA 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 psig) for 1min, followed by 0 kPa (0 psig) for 54 min.A retaining screen is not used to support the sample.B 0 kPa (0 psig) for 5 min, followed by 13.8 kPa (2 p
34、sig) for 1min, followed by 0 kPa (0 psig) for 54 min.A retaining screen is used to support the sample. The typemust be specified in the report.F1670082kPa (2 psig). This hydrostatic pressure has been documented todiscriminate between protective clothing material performanceand correlate with visual
35、penetration results that are obtainedwith 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 tounderstand that this test method does not simulate all thephysical stresses a
36、nd pressures that are exerted on protectiveclothing garments during actual use. This test method is offeredto identify those protective clothing materials that warrantfurther evaluation with a microbiological challenge.5.5 Since this test method uses visual observation ratherthan analytical measurem
37、ents for determination of penetration,use this test method as a preliminary evaluation for possiblepenetration of blood and other body fluids. Perform subsequenttesting with a microbiological challenge and analytical tech-nique using Test Method F 1671.NOTE 1No viral resistance claims can be made ba
38、sed on this testmethod as materials can pass the test method and fail Test Method F 1671.5.6 Testing without considering degradation by physical,chemical, and thermal stresses which could negatively impactthe performance of the protective barrier, could lead to a falsesense of security. Consider tes
39、ts which assess the impact ofstorage conditions and shelf life for disposable products, andthe effects of laundering and sterilization for reusable products.The integrity of the protective barrier can also be compromisedduring use by such effects as flexing and abrasion (5). It is alsopossible that
40、prewetting by contaminating materials such asalcohol and perspiration can also compromise the integrity ofthe protective barrier. If these conditions are of concern,evaluate the performance of protective clothing materials forsynthetic blood penetration following an appropriate precon-ditioning tech
41、nique representative of the expected conditionsof use.5.7 While this test method involves a qualitative determi-nation of the protective clothing material resistance to penetra-tion by synthetic blood under specific test conditions, it ispossible to use this test method as a material quality control
42、 orassurance procedure.5.7.1 If this procedure is used for quality control, performproper statistical design and analysis of the data, when morethan three specimens are tested. This type of analysis includes,but is not limited to, the number of individual specimens tested,the average percent passing
43、 and/or failing with a standarddeviation. Data reported in this way helps to establish confi-dence limits concerning product performance. Examples ofacceptable sampling plans are found in references such asMIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859-1.6. Apparatus6.1 Thickness Gauge, suitable for meas
44、uring thickness tothe nearest 0.02 mm (or nearest 0.001 in.), in accordance withTest Method D 1777 (Optional).86.2 Penetration Test Cell,9,10to restrain the specimen duringcontact with the pressurized test synthetic blood. In the testcell, the specimen acts as a partition separating synthetic bloodf
45、rom the view side of the test cell. It consists of a cell body thatis fastened to a cell support. The cell body has a capacity ofapproximately 60 mL (2.0 oz) for synthetic blood. A flangecover, with an open area to allow visual observation and atransparent cover are included. The cell body has a top
46、 port forfilling and a drain valve for draining the penetration test cell.Other items, such as a fitting to allow attachment of the air lineto the top port in the cell body, gaskets, and the retaining screenare also required. Specifications for the penetration test cell areprovided in Test Method F
47、903. A diagram of the test cell andapparatus are provided in Figs. 1 and 2, respectively.6.3 Retaining Screen,11,10a smooth finish plastic or metalsquare mesh screen meeting the following specifications usedfor Procedure B from Table 1:% open area 50Should limit deflection of sample to = 5.0 mm (0.2
48、 in.)8Thickness of each protective clothing material specimen tested may bedetermined prior to performing the test procedure, but is not required to comply withthis test method. The thickness data for the material may be available from themanufacturer.9The sole source of supply of the penetration te
49、st apparatus known to thecommittee at this time is Wilson Road Machine Shop, 1170 Wilson Road, RisingSun, MD 21911.10If you are aware of alternative suppliers, please provide this information toASTM International Headquarters. Your comments will receive careful consider-ation at a meeting of the responsible technical committee,1which you may attend.11Acceptable retaining screen materials are 11 by 11 nylon screen (No.9818T12), 14 by 14 polypropylene screen (No. 9275T11), and 13 by 13 polyesterscreen (No. 9218T12) from McMaster-Carr Supply Co., P.O. Box 4355, Chicag
