1、Designation: F1670/F1670M 17aStandard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Synthetic Blood1This standard is issued under the fixed designation F1670/F1670M; the number immediately following the designation indicates the yearof original adoption or, in t
2、he 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.NoteA correction was made to 7.1.2 and the year date was changed on Oct. 25, 2017.INTRODUCTIONWor
3、kers, primarily those in the healthcare profession, involved in treating and caring for individuals injured orsick, can be exposed to biological liquids capable of transmitting disease. These diseases, which may be caused bya variety of microorganisms, can pose significant risks to life and health.
4、This is especially true of blood-bornehepatitis (hepatitis B virus (HBV) and hepatitis C virus (HCV) and acquired immune deficiency syndrome (AIDS)(human immunodeficiency viruses (HIV). Since engineering controls can not eliminate all possible exposures,attention is placed on reducing the potential
5、of direct skin contact through the use of protective clothing that resistspenetration (29 CFR Part 1910.1030). This test method was developed to help assess the effectiveness of materialsused in protective clothing for protecting the wearer against contact with body fluids that potentially containbl
6、ood-borne pathogens. Using synthetic blood, this test method is intended to identify protective clothing materialcandidates for further testing according to a more rigorous procedure involving a surrogate for blood-bornepathogens.1. Scope1.1 This test method is used to evaluate the resistance ofmate
7、rials used in protective clothing to penetration by syntheticblood under conditions of continuous 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 mater
8、ials having thick, inner liners whichreadily absorb the synthetic blood.1.2 This test method is a means for selecting protectiveclothing materials for subsequent testing with a more sophis-ticated barrier test as described in Test Method F1671.1.3 This test method does not apply to all forms or cond
9、i-tions of blood-borne pathogen exposure. Users of the testmethod must review modes for work/clothing 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 exampl
10、e,seams) used in protective clothing. This test method does notaddress the design, overall construction and components, orinterfaces of garments, or other factors which may affect theoverall protection offered by the protective clothing.1.5 The values stated in either SI units or inch-pound unitsare
11、 to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in nonconformancewith the standard.1.6 This standard does not purport to address all o
12、f thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in a
13、ccor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.1This test method is under
14、the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Oct. 25, 2017. Published October 2017. Originallyapproved in 1995. Last previous edition approved in 2017 as F1670/F1670M 1
15、7.DOI: 10.1520/F1670_F1670M-17A.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Princi
16、ples for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12. Referenced Documents2.1 ASTM Standards:2D1331 Test Methods for Surface and Interfacial Tension ofSolutions of Paints, Solvents, Soluti
17、ons of Surface-ActiveAgents, and Related MaterialsD1777 Test Method for Thickness of Textile MaterialsD3776 Test Methods for Mass Per Unit Area (Weight) ofFabricE105 Practice for Probability Sampling of MaterialsE171 Practice for Conditioning and Testing Flexible BarrierPackagingF903 Test Method for
18、 Resistance of Materials Used inProtective Clothing to Penetration by LiquidsF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2 Military Standard:3MIL-STD-105 Sampling Procedure
19、s and Tables for Inspec-tion by Attributes2.3 ANSI/ASQC Standards:4ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-spection 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 Pathogen
20、s: Final Rule, Federal Register, Vol 56,No 235, Dec. 6, 1991, pp. 6175641823. Terminology3.1 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 excretedby
21、 the human body.3.2.1 DiscussionIn this test method, body fluids includethose liquids potentially 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
22、, and any body fluid thatis visibly contaminated with blood, and all body fluids insituations where it is difficult or impossible to differentiatebetween body fluids (see 29 CFR Part 1910.1030).3.3 body fluid simulant, na liquid which is used to act asa model for human body fluids.3.3.1 DiscussionIn
23、 this test method, synthetic blood isused as a body fluid simulant.3.4 penetration, nthe movement of matter throughclosures, porous materials, seams, and pinholes or otherimperfections in protective clothing on a nonmolecular level.3.4.1 DiscussionFor this test method, the specific matteris syntheti
24、c blood.3.4.2 DiscussionIn this test method, the penetration liquidis synthetic blood.3.5 protective clothing, nan 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
25、 from contamination by thewearer of the clothing.3.5.1 DiscussionThe potential hazard is contact withblood.3.6 synthetic 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 co
26、lor of blood.3.6.1 DiscussionThe synthetic blood in this test methoddoes not simulate all of the characteristics of real blood or bodyfluids, for example, polarity (a wetting characteristic),coagulation, content of cell matter.4. Summary of Test Method4.1 A specimen is subjected to a body fluid simu
27、lant(synthetic blood) for a specified time and pressure.4.2 Visual observation is made to determine when, or if,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
28、 F903 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 clothing.5.1.1
29、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 Medical protective
30、 clothing materials are intended to bea barrier to blood, body fluids, and other potentially infectiousmaterials. Many factors can affect the wetting and penetrationcharacteristics of body fluids, such as surface tension,viscosity, and polarity of the fluid, as well as the structure andrelative hydr
31、ophilicity or hydrophobicity of the materials. Thesurface tension range for blood and body fluids (excludingsaliva) is approximately 0.042 to 0.060 N/m (1).7To help2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Boo
32、k of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available 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. Wisco
33、nsin Ave.,Milwaukee, WI 53202.5Available from American 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,Washington, DC 20402.7The boldface numbers in parentheses refer to the list
34、 of references at the end ofthis standard.F1670/F1670M 17a2simulate the wetting characteristics of blood and body fluids,the surface tension of the synthetic blood is adjusted toapproximate the lower end of this surface tension range. Theresulting surface tension of the synthetic blood is approxi-ma
35、tely 0.042 6 0.002 N/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 ProceduresAand B in Table 1 forexposing the protective clothing material specimens withsynthetic
36、 blood involves pressurization of the test cell to13.8 kPa 2 psig. This hydrostatic pressure has been docu-mented to discriminate between protective clothing materialperformance and to correlate with visual penetration resultsthat are obtained with a human factors validation (2). Somestudies, howeve
37、r, suggest that mechanical pressures exceeding345 kPa 50 psig can occur during clinical use (3, 4).Therefore, it is important to understand that this test methoddoes not simulate all the physical stresses and pressures that areexerted on protective clothing garments during actual use. Thistest metho
38、d is offered to identify those protective clothingmaterials that warrant further evaluation with a microbiologicalchallenge.5.5 Since this test method uses visual observation ratherthan analytical measurements for determination of penetration,use this test method as a preliminary evaluation for poss
39、iblepenetration of blood and other body fluids. Perform subsequenttesting with a microbiological challenge and analytical tech-nique using Test Method F1671.NOTE 1No viral resistance claims can be made based on this testmethod, as materials can pass the test method and fail Test Method F1671.5.6 Tes
40、ting 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 tests which assess the impact ofstorage conditions and shelf life for disposable products, andthe ef
41、fects 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 prewetting by contaminating materials such asalcohol and perspiration can also compromise the int
42、egrity ofthe protective barrier. If these conditions are of concern,evaluate the performance of protective clothing materials forsynthetic blood penetration following an appropriate precon-ditioning technique representative of the expected conditionsof use.5.7 While this test method involves a quali
43、tative 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 orassurance procedure.5.7.1 If this procedure is used for quality control, performproper statist
44、ical 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 or failing, or both, with a standarddeviation. Data reported in this way helps to establish confi
45、-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 measuring thickness tothe nearest 0.02 mm or nearest 0.001 in., in accordance withTest Method D1
46、777 (optional).88Thickness 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.TABLE 1 Specimen Exposure ProceduresP
47、rocedure 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 psig for 1min, followed by 0 kPa 0 psi
48、g for 54 min.A retaining screen is used to support the sample. The typemust be specified in the report.FIG. 1 Exploded View of the Penetration Test Cell with Retain-ing ScreenF1670/F1670M 17a36.2 Penetration Test Cell,9to restrain the specimen duringcontact with the pressurized test synthetic blood.
49、 In the testcell, the specimen acts as a partition separating synthetic bloodfrom 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 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,
