1、Designation: F 1819 07Standard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Synthetic Blood Using a MechanicalPressure Technique1This standard is issued under the fixed designation F 1819; the number immediately following the designation indicates the year ofor
2、iginal 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 health care profession, invo
3、lved 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 blood-borne viruses which caus
4、e Hepatitis (Hepatitis B Virus (HBV)and Hepatitis C Virus (HCV) and Acquired Immune Deficiency Syndrome (AIDS) (HumanImmunodeficiency Viruses (HIV). Since engineering controls cannot eliminate all possible exposures,attention is placed on reducing the potential for direct skin contact through the us
5、e of protectiveclothing that resists penetration (29 CFR Part 1910.1030). This test method was developed to helpassess the effectiveness of materials used in protective clothing for protecting the wearer againstcontact with body fluids that potentially contain blood-borne pathogens. Using synthetic
6、blood, thistest method is intended to determine the amount of mechanical pressure that will cause penetration ofa liquid through a material used in protective clothing.1. Scope1.1 This test method is used to evaluate the resistance ofmaterials used in protective clothing to synthetic blood underthe
7、conditions of liquid contact and increasing direct mechani-cal pressure. The penetration resistance of protective clothingis based on visual detection of synthetic blood penetration at aspecific applied mechanical pressure.1.2 This test method does not apply to all forms or condi-tions of blood-born
8、e pathogen exposure. Users of the testmethod must review modes for work/clothing exposure andassess the appropriateness of this test method for their specificapplication.1.3 This test method addresses only the performance ofmaterials or certain material constructions (for example,seams) used in prot
9、ective clothing. This test method does notaddress the design, overall construction, components, or inter-faces of garments, or other factors which may affect the overallprotection offered by the protective clothing.1.4 The values in SI units or in other units shall be regardedseparately as standard.
10、 The values stated in each system mustbe used independently of the other, without combining valuesin any way.1.5 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
11、 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 Method for Thickness of Textile MaterialsD 3776 Test Method
12、 for Mass Per Unit Area (Weight) ofFabricE 105 Practice for Probability Sampling Of MaterialsE 171 Specification for Atmospheres for Conditioning andTesting Flexible Barrier Materials1This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is
13、the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 1997. Last previous edition approved in 2004 as F 1819-04.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer
14、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 Conshohocken, PA 19428-2959, United States.E 691 Practice for Conducting an Interla
15、boratory Study toDetermine the Precision of a Test MethodF 1494 Terminology Relating to Protective ClothingF 1670 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Synthetic BloodF 1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetrati
16、on by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2 ANSI/ASQC Standards3ANSI/ASQC Z1.4 Sampling Procedures and Tables forInspection by Attributes2.3 ISO Standard4ISO 2859-1 Sampling Plans for Inspection by Attributes2.4 Military Standard5MIL-STD-105 Sampling Proc
17、edures and Tables for Inspec-tion by Attributes2.5 OSHA Standard6CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule, Federal Register, Vol 56, No235, Dec. 6, 1991, pp. 6417564182.3. Terminology3.1 Definitions:3.1.1 blood-borne pathogen, nan infectious bacterium,virus, or o
18、ther disease inducing microbe carried in blood orother potentially infectious body fluids.3.1.2 body fluid, nany liquid produced, secreted, or ex-creted by the human body.3.1.2.1 DiscussionIn this test method, body fluids includethose liquids potentially infected with blood-borne pathogens,including
19、, 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 insituations where it is difficult or impossible to differenti
20、atebetween body fluids (see 29 CFR Part 1910.1030).3.1.3 body fluid simulant, na liquid which is used to act asa model for human body fluids.3.1.4 hydrostatic pressure, nthe force exerted by a staticliquid (1)73.1.5 mechanical pressure, nthe force exerted by onesolid object upon another that it is t
21、ouching. (1)3.1.6 penetration, nthe movement of matter through clo-sures, porous materials, seams, and pinholes or other imper-fections in protective clothing on a nonmolecular level.3.1.6.1 DiscussionFor this test method, the specific mat-ter is synthetic blood.3.1.7 protective clothing, nan item o
22、f 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.3.1.7.1 DiscussionIn this test method, the potential haz-ard of contact
23、with blood or other body fluids is simulated.3.1.8 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 color of blood.3.1.8.1 DiscussionThe synthetic blood in this t
24、est methoddoes not simulate all of the characteristics of real blood or bodyfluids, for example, polarity (a wetting characteristic), coagu-lation, content of cell matter.3.1.9 For definitions of other protective clothing-relatedterms used in this test method, refer to Terminology F 1494.4. Summary
25、of Test Method4.1 Using a special test apparatus, a specimen is contactedwith synthetic blood under a continuously increasing mechani-cal pressure until the synthetic blood penetrates the specimenor a load of 90.7 kg 200 lbs is applied to a 57.2 mm 2.25 in.diameter portion of the specimen achieving
26、a pressure on thetested specimen of 345 kPa 50 psig.4.2 The specimens non-contact side is observed to deter-mine if visual penetration occurs, and if so, at what mechanicalpressure the penetration occurs.4.3 In conducting a test, the cover plate containing a testhead is locked on the two side suppor
27、ts of the base plate of thetest apparatus, the multi-position switch is turned to the manualup position, and the test button on top of the control box is helddown until visible penetration of the test specimen by syntheticblood is observed through the circular test head. Releasing thebutton stops th
28、e drive motor, and the penetration pressure isshown digitally on the display unit and recorded by thetechnician.5. Significance and Use5.1 This test method was modeled after a procedure com-monly known as the Elbow Lean Test.8The Elbow Lean Testinvolves the application of synthetic blood to an ink p
29、ad,placement of sample fabric over the blood soaked pad, place-ment of a blotter over the sample fabric, and applying elbow orfingertip pressure on top of the blotter. The blotter is thenexamined for staining as evidence of blood penetration. Thistest method provides similar procedures which standar
30、dize thetest equipment and application of pressure through an adoptedmethodology.5.2 This test method is intended to simulate actual useconditions wherein areas of the health care workers protectiveclothing are soaked with blood and compressed between thepatients body and that of the health care wor
31、ker, or similarlybetween the health care worker and instruments. In both cases,unconfined blood can move away from the pressure point3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.4Available from American National Standards Institute (ANSI), 25 W. 43rd
32、 St.,4th Floor, New York, NY 10036.5Available from Standardization Documents Order Desk, Bldg. 4, Section D,700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.6Available from Supt. of Documents, U.S. Government Printing Office, Wash-ington, DC 20402.7The boldface numbers in parentheses refer
33、 to the list of references at the end ofthis standard.8Originally developed by W.L.Gore and Assoc., Inc., Elkton, MD 21921.F1819072taking the path of least resistance rather than being containedas in Test Methods F 1670 and F 1671.5.3 This test method uses predominately mechanical pres-sure as oppos
34、ed to contained, hydrostatic pressure to demon-strate liquid penetration resistance (1,2). It simulates a singleinsult in which the outer surfaces of a protective clothing itemare compressed at a steady rate by the wearers body against awet surface. This steady rate of compression represents onepote
35、ntial use scenario. Other scenarios may result in a widevariety of pressure ramp rates and profiles that are notsimulated by the test apparatus.5.4 Because this test method provides quantitative results, itis useful for discriminating differences in the liquid barrierperformance of protective clothi
36、ng materials. This test methodcan be used for measuring differences in the penetrationpressure for protective clothing materials which do not passTest Method F 1670.5.5 This test method is normally used to evaluate specimensfrom individual finished items of protective clothing andindividual samples
37、of materials that are candidates for items ofprotective clothing.5.5.1 Finished items of protective clothing include gloves,arm shields, aprons, gowns, hoods, and boots.5.5.2 The phrase specimens from finished items encom-passes seamed and other discontinuous regions as well as theusual continuous r
38、egions of protective clothing items.5.6 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 as surface tension, viscos-ity, and pola
39、rity of the fluid, as well as the structure and relativehydrophilicity or hydrophobicity of the materials. The syn-thetic blood solution may exhibit different wetting behavior onfabrics or films with identical structures but different chemicalcompositions. The surface tension range for blood and bod
40、yfluids (excluding saliva) is approximately 0.042 to 0.060 N/m(3). To help simulate the wetting characteristics of blood andbody fluids, the surface tension of the synthetic blood isadjusted to approximate the lower end of this surface tensionrange. The resulting surface tension of the synthetic blo
41、od is0.042 6 0.002 N/m.5.7 The synthetic blood mixture is prepared with a red dyeto aid in visual detection and a thickening agent to simulate theflow characteristics of blood. The synthetic blood may notduplicate the polarity, and thus wetting behavior and subse-quent penetration, of real blood and
42、 other body fluids throughprotective clothing materials.5.8 It is 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
43、 (4,5,6). No viral resistance claims can be madebased on this test method as materials can pass this test methodand fail Test Method F 1671.5.9 Part of the protocol for exposing the protective clothingmaterial specimens to synthetic blood involves applying me-chanical pressure up to 345 kPa 50 psig.
44、 This mechanicalpressure has been documented to discriminate protective cloth-ing material performance and correlate with visual penetrationresults that are obtained with one type of human factorsvalidation, the Elbow Lean Test.1The Elbow Lean Test doesnot simulate all of the possible types of clini
45、cal exposure asthere is one contact with liquid under high mechanical pressurefor a short duration. Some studies suggest that mechanicalpressures exceeding 345 kPa 50 psig can occur duringclinical use (8,9).NOTE 1The mechanical pressure tester can be adjusted to evaluatematerials at higher pressures
46、.5.10 Testing prior to degradation by physical, chemical, andthermal stresses which could negatively impact the perfor-mance of the protective barrier, could lead to a false sense ofsecurity. Consider tests which assess the impact of storageconditions and shelf life for disposable products, and thee
47、ffects of laundering and sterilization for reusable products.The integrity of the protective clothing can also be compro-mised during use by such effects as flexing and abrasion (10).It is also possible that prewetting by contaminants such asalcohol and perspiration can compromise the integrity of t
48、heprotective clothing. Furthermore, high relative humidity mayalso affect the resistance of materials used in protectiveclothing to penetration by blood and other body fluids. If theseconditions are of concern, evaluate the performance of protec-tive clothing for synthetic blood penetration followin
49、g anappropriate pretreatment technique representative of the ex-pected conditions of use.5.11 This test method involves a quantitative determinationof a protective clothing penetration resistance to syntheticblood under specific test conditions. It can also be used as aqualitative method for comparing the penetration resistancecharacteristics of similar materials and as a material qualitycontrol or assurance procedure.5.12 If this test method is used for quality control, performproper statistical design and analysis of larger data sets wheremore than three
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