1、Designation: F1819 07 (Reapproved 2013)Standard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Synthetic Blood Using a MechanicalPressure Technique1This standard is issued under the fixed designation F1819; the number immediately following the designation indicat
2、es 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 () indicates an editorial change since the last revision or reapproval.INTRODUCTIONWorkers, primarily those in the health care p
3、rofession, 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 blood-borne vir
4、uses which cause 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
5、 through the use 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. U
6、sing synthetic 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
7、blood underthe 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-tion
8、s 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.1.3 This test method addresses only the performance ofmaterials or certain material constructions (for example,seam
9、s) used in protective 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 regardedseparate
10、ly as standard. 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 appr
11、o-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 Surface and Interfacial Tension ofSolutions of Surface-Active AgentsD1777 Test Method for Thickness of Textile MaterialsD3776
12、 Test Methods for Mass Per Unit Area (Weight) ofFabricE105 Practice for Probability Sampling of MaterialsE171 Practice for Conditioning and Testing Flexible BarrierPackagingE691 Practice for Conducting an Interlaboratory Study to1This test method is under the jurisdiction ofASTM Committee F23 on Per
13、sonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biological.Current edition approved Jan. 1, 2013. Published January 2013. Originallyapproved in 1997. Last previous edition approved in 2007 as F1819-07. DOI:10.1520/F1819-07R13.2For referenced ASTM stan
14、dards, 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, P
15、A 19428-2959. United States1Determine the Precision of a Test MethodF1494 Terminology Relating to Protective ClothingF1670 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Synthetic BloodF1671 Test Method for Resistance of Materials Used inProtective Clothing to P
16、enetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2 ANSI/ASQC Standards3ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-spection by Attributes2.3 ISO Standard4ISO 2859-1 Sampling Plans for Inspection by Attributes2.4 Military Standard5MIL-STD-105 Sam
17、pling Procedures and Tables for Inspec-tion by Attributes2.5 OSHA Standard6CFR Part 1910.1030 Occupational Exposure to Blood-bornePathogens: Final Rule, Federal Register, Vol 56, No 235,Dec. 6, 1991, pp. 6417564182.3. Terminology3.1 Definitions:3.1.1 blood-borne pathogen, nan infectious bacterium,vi
18、rus, or other 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,
19、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 insituations where it is difficult or impossible to d
20、ifferentiatebetween 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 tha
21、t it is touching. (1)3.1.6 penetration, nthe movement of matter throughclosures, porous materials, seams, and pinholes or otherimperfections in protective clothing on a nonmolecular level.3.1.6.1 DiscussionFor this test method, the specific matteris synthetic blood.3.1.7 protective clothing, nan ite
22、m 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.3.1.7.1 DiscussionIn this test method, the potential hazardof 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
24、test methoddoes not simulate all of the characteristics of real blood or bodyfluids, for example, polarity (a wetting characteristic),coagulation, content of cell matter.3.1.9 For definitions of other protective clothing-relatedterms used in this test method, refer to Terminology F1494.4. Summary of
25、 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 achievin
26、g 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 su
27、pports 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 stop
28、s the 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 i
29、nk pad,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 sta
30、ndardize 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 the3Available from American Society for Qual
31、ity (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., P
32、hiladelphia, PA 19111-5098, http:/dodssp.daps.dla.mil.6Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.7The boldface numbers in parentheses refer to the list of references at the end oft
33、his standard.8Originally developed by W.L.Gore and Assoc., Inc., Elkton, MD 21921.F1819 07 (2013)2patients body and that of the health care worker, or similarlybetween the health care worker and instruments. In both cases,unconfined blood can move away from the pressure pointtaking the path of least
34、 resistance rather than being containedas in Test Methods F1670 and F1671.5.3 This test method uses predominately mechanical pres-sure as opposed to contained, hydrostatic pressure to demon-strate liquid penetration resistance (1,2). It simulates a singleinsult in which the outer surfaces of a prote
35、ctive clothing itemare compressed at a steady rate by the wearers body against awet surface. This steady rate of compression represents onepotential 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 t
36、his test method provides quantitative results, itis useful for discriminating differences in the liquid barrierperformance of protective clothing materials. This test methodcan be used for measuring differences in the penetrationpressure for protective clothing materials which do not passTest Method
37、 F1670.5.5 This test method is normally used to evaluate specimensfrom individual finished items of protective clothing andindividual samples of materials that are candidates for items ofprotective clothing.5.5.1 Finished items of protective clothing include gloves,arm shields, aprons, gowns, hoods,
38、 and boots.5.5.2 The phrase specimens from finished items encom-passes seamed and other discontinuous regions as well as theusual continuous regions of protective clothing items.5.6 Medical protective clothing materials are intended to bea barrier to blood, body fluids, and other potentially infecti
39、ousmaterials. 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 hydrophilicity or hydrophobicity of the materials. Thesynthetic blood solution may exhibit different wet
40、ting behavioron fabrics or films with identical structures but differentchemical compositions. The surface tension range for bloodand body fluids (excluding saliva) is approximately 0.042 to0.060 N/m (3). To help simulate the wetting characteristics ofblood and body fluids, the surface tension of th
41、e syntheticblood is adjusted to approximate the lower end of this surfacetension range. The resulting surface tension of the syntheticblood is 0.042 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 characteris
42、tics of blood. The synthetic blood may notduplicate the polarity, and thus wetting behavior and subse-quent penetration, of real blood and other body fluids throughprotective clothing materials.5.8 It is known that body fluids penetrating protectiveclothing materials are likely to carry microbiologi
43、cal contami-nants; however, visual detection methods are not sensitiveenough to detect minute amounts of liquid containing micro-organisms (4,5,6). No viral resistance claims can be madebased on this test method as materials can pass this test methodand fail Test Method F1671.5.9 Part of the protoco
44、l for exposing the protective clothingmaterial specimens to synthetic blood involves applying me-chanical pressure up to 345 kPa (50 psig). This mechanicalpressure has been documented to discriminate protective cloth-ing material performance and correlate with visual penetrationresults that are obta
45、ined with one type of human factorsvalidation, the Elbow Lean Test.1The Elbow Lean Test doesnot simulate all of the possible types of clinical exposure asthere is one contact with liquid under high mechanical pressurefor a short duration. Some studies suggest that mechanicalpressures exceeding 345 k
46、Pa (50 psig) can occur duringclinical use (8,9).NOTE 1The mechanical pressure tester can be adjusted to evaluatematerials at higher pressures.5.10 Testing prior to degradation by physical, chemical, andthermal stresses which could negatively impact the perfor-mance of the protective barrier, could l
47、ead to a false sense ofsecurity. Consider tests which assess the impact of storageconditions and shelf life for disposable products, and theeffects of laundering and sterilization for reusable products.The integrity of the protective clothing can also be compro-mised during use by such effects as fl
48、exing and abrasion (10).It is also possible that prewetting by contaminants such asalcohol and perspiration can compromise the integrity of theprotective clothing. Furthermore, high relative humidity mayalso affect the resistance of materials used in protectiveclothing to penetration by blood and ot
49、her body fluids. If theseconditions are of concern, evaluate the performance of protec-tive clothing for synthetic blood penetration following 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
