1、Designation: F1670/F1670M 08 (Reapproved 2014)1Standard 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
2、 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.1NOTEUnits information was editorially corrected in June 2014.INTRODUCTIONWorke
3、rs, 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. Th
4、is is especially true of blood-borne, Hepatitis Hepatitis B Virus (HBV) and Hepatitis CVirus (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
5、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 effectivenessof materials used in protective clothing for protecting the wearer against contact with body fluids thatpotentially contain blood
6、-borne pathogens. Using synthetic blood, this test method is intended toidentify protective clothing 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 ofmateria
7、ls 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 material
8、s 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 condi-t
9、ions 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 example,s
10、eams) 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 to
11、 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 non-conformancewith the standard.1.6 This standard does not purport to address all of
12、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 limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1331 Test Methods for Su
13、rface and Interfacial Tension ofSolutions of Surface-Active AgentsD1777 Test Method for Thickness of Textile Materials1This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Cur
14、rent edition approved June 15, 2014. Published June 2014. Originallyapproved in 1995. Last previous edition approved in 2008 as F1670 08. DOI:10.1520/F1670_F1670M-08R14E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For An
15、nual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1D3776 Test Methods for Mass Per Unit Area (Weight) ofFabricE105 Practice fo
16、r Probability Sampling of MaterialsE171 Practice for Conditioning and Testing Flexible BarrierPackagingF903 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by LiquidsF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Bor
17、ne 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 Procedures and Tables for In-spection by Attributes2.4 ISO Standard:5ISO 2859-1 Sampli
18、ng 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 blood-borne pathogen, nan infectious secreted orexcreted bacterium, virus, or other
19、 disease inducing microbecarried in blood or other body fluids.3.2 body fluid, nany liquid produced, secreted, or excretedby 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, seme
20、n, 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 insituations where it is difficult or impossible to differentiatebetween body fluids.63.3 body
21、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 throughclosures, porous materials, seams, and pinholes or otherimperfections in protective clot
22、hing 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 item of clothing that isspecifically designed and constructed for the intended purposeof
23、 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 synthetic blood, na mixture of a red dye/surfactant,thickening agent, and distilled water ha
24、ving 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 of real blood or bodyfluids, for example, polarity (a wetting characteristic),coagulation,
25、 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,penetration occurs.4.3 Any evidence of synthetic blood penetration constitutesfailure. Resu
26、lts are reported as pass/fail.5. Significance and Use5.1 This test method is based on Test Method F903 formeasuring resistance of chemical protective clothing materialsto penetration by liquids. This test method is normally used toevaluate specimens from individual finished items of protectiveclothi
27、ng 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.5.1.2 The phrase “specimens from finished items” encom-passes seamed and other discontinuous r
28、egions 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 infectiousmaterials. Many factors can affect the wetting and penetrationcharacteristics of body fluids, such a
29、s surface tension,viscosity, and polarity of the fluid, as well as the structure andrelative hydrophilicity 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 helpsimulate the wetting characteristics of
30、 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-mately 0.042 6 0.002 N/m.5.3 The synthetic blood mixture is prepared with a red dyeto aid in visual
31、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 with3Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA
32、 19111-5094, Attn: NPODS.4Available from American Society for Quality Control, 611 E. Wisconsin 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
33、Printing Office,Washington, DC 20402.7The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F1670/F1670M 08 (2014)12synthetic blood involves pressurization of the test cell to 13.8kPa 2 psig. This hydrostatic pressure has been documented todiscriminate betwee
34、n protective clothing material performanceand correlate with visual penetration results that are obtainedwith a human factors validation (2). Some studies, however,suggest that mechanical pressures exceeding 345 kPa 50 psigcan occur during clinical use (3, 4). Therefore, it is importantto understand
35、 that this test method does not simulate all thephysical stresses and 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
36、 test method uses visual observation ratherthan analytical measurements 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
37、 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 Testing without considering degradation by physical,chemical, and thermal stresses which could negatively impactthe performance of the protect
38、ive barrier, could lead to a falsesense of security. Consider tests 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 s
39、uch effects as flexing and abrasion (5). It is alsopossible that 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
40、 blood penetration following an appropriate precon-ditioning technique 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
41、 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 statistical design and analysis of the data, when morethan three specimens are tested. This type of analysis includes,but is not limited to, the
42、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-dence limits concerning product performance. Examples ofacceptable sampling plans are found in references such asMIL-STD-105, ANSI/ASQC
43、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 D1777 (Optional).86.2 Penetration Test Cell,9,10to restrain the specimen duringcontact with the pressurized test synthetic blood. In the te
44、stcell, 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 observ
45、ation 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, gaskets, and the retaining screenare also required. Specific
46、ations for the penetration test cell are8Thickness 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 sou
47、rce of supply of the penetration test 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 con
48、sider-ation at a meeting of the responsible technical committee,1which you may attend.TABLE 1 Specimen 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 scree
49、n 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 psig 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 08 (2014)13provided in Test Method F903. 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 specifi
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