1、Designation: F2878 10Standard Test Method forProtective Clothing Material Resistance to HypodermicNeedle Puncture1This standard is issued under the fixed designation F2878; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year o
2、f last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONOccupational exposures to bloodborne pathogens (BBP) caused by needlestick injuries are aconcern for healthcare prof
3、essionals, law enforcement officers, first responders and others.Transmission of diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis C (Hep C)as a result of percutaneous needlestick injuries have been documented worldwide. These diseases canlead to life-long chronic health problems and
4、 possibly death.Work practice safety procedures, including the use of personal protective equipment (PPE) such asgloves, aprons, and sleeves, are used to diminish the risk of occupational exposure to BBPs throughneedlestick injury.The purpose of this standard is to measure relative hypodermic needle
5、 puncture resistance offeredby various materials based on the conditions specified within the standard. This standard does notattempt to simulate all use conditions. A number of variables which impact puncture resistance are notaddressed by this standard. For example, stiffness of backing materials,
6、 presence of lubricants, andtension on the specimen may all impact puncture resistance, but are not considered by this standard.This standard defines three common hypodermic needles to evaluate puncture resistance. Throughdevelopment of this standard, it has been observed that needle diameter has an
7、 effect on punctureresistance. Therefore needles of various diameters have been specified. Users of this method mayspecify testing with one or more of the needles defined within the standard.The hypodermic needles referenced have been selected with consideration to three main points:(1) As needle ga
8、uge increases the load required to puncture materials taken from commonlyavailable hypodermic needle resistant PPE increases. The performance is not linear and thereforerelatively large gauge (21g) and small gauge (28g) needles are provided to better understand amaterials performance against one end
9、 of the spectrum or the other.(2) Certain end-use applications are concerned with protection from either large gauge needles orsmall gauge needles. For example, police officers searching suspected intravenous drug users are mostcommonly at risk of injury from fine gauge needles (28g), but not large
10、gauge needles. Whereas,workers inoculating poultry on commercial farms may be concerned with large gauge needles (21g),but not small gauge needles.(3) Certain materials are optimized to resist either large gauge or small gauge needles and testingagainst the other would not be useful. Other materials
11、 may be engineered for resistance to the fullbreadth of the gauge spectrum. For example, in applications, such as healthcare, where a broad rangeof needle gauges are expected, testing against both ends of the spectrum allows for a betterunderstanding of robustness.1. Scope1.1 This test method is use
12、d to determine the force requiredto cause a sharp-edged puncture probe (hypodermic needle) topenetrate through protective clothing material. The standarddescribes three test probes that may be used: 21-, 25-, or28-gauge needles.1.2 The values stated in SI units are to be regarded asstandard. No othe
13、r units of measurement are included in thisstandard.1This test method is under the jurisdiction ofASTM Committee F23 on PersonalProtective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.20 on Physical.Current edition approved Nov. 1, 2010. Published January 2011. DOI:10.1
14、520/F2878-10.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.1.3 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
15、appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1776 Practice for Conditioning and Testing TextilesD1777 Test Method for Thickness of Textile MaterialsD2000 Classification System for Rubber P
16、roducts in Auto-motive ApplicationsD2582 Test Method for Puncture-Propagation Tear Resis-tance of Plastic Film and Thin SheetingE4 Practices for Force Verification of Testing MachinesF1342 Test Method for Protective Clothing Material Resis-tance to Puncture3. Terminology3.1 Definitions:3.1.1 protect
17、ive clothing material, nany material or com-bination of materials used in an item of clothing for the purposeof isolating parts of the wearers body from a potential hazard.3.1.2 hypodermic needle, na hollow bore stainless steelcylinder with a beveled tip used to penetrate the skin bycutting; often u
18、sed in conjunction with a syringe for injectingor withdrawing fluids.4. Summary of Test Method4.1 A material specimen is placed in a support assembly(see Fig. 1) that is affixed to the upper or lower arm, dependingon machine configuration, of a tension testing machine. Somematerials have different p
19、erformance based on which face ispresented toward the needle. Care should be taken whenmounting to ensure the needle initiates puncture on the desiredface. When reporting results include which side was facing theneedle.4.2 A pointed puncture probe of set dimensions is mountedto the penetrometer stan
20、d and the whole assembly is attachedto the compression cell of the tension testing machine.4.3 The puncture probe which is positioned perpendicular tothe specimen is moved at a constant velocity until the tip of theprobe perforates the backside of the material specimen.4.4 The maximum force required
21、 to puncture the materialspecimen is measured by the compression cell.4.4.1 The average of twelve test replicates is reported as thepuncture resistance.5. Significance and Use5.1 This test method evaluates puncture resistance of pro-tective clothing materials which may include: plastics orelastomeri
22、c films, coated fabrics, flexible materials, laminates,leathers or textile materials.5.1.1 This test method uses hypodermic needles with speci-fied dimensions as puncture probes.5.1.2 This test method evaluates puncture resistance ofprotective clothing materials, perpendicular to the materialssurfac
23、e and with no supporting structure under/behind thematerial specimen.5.1.3 Evaluation of puncture resistance for snag-type punc-ture should be performed in accordance with Test MethodD2582.5.1.4 Evaluation of puncture resistance for non-cuttingpuncture should be performed in accordance with Test Met
24、hodF1342.6. Apparatus6.1 Thickness Gauge, suitable for measuring thickness tothe nearest 0.01 mm, as specified in Test Method D1777 shallbe used to determine the thickness of each protective clothingspecimen tested.6.2 Testing Machine, shall meet the following criteria:6.2.1 It shall be capable of h
25、olding the specimen securelybetween the two clamps.6.2.2 A machine capable of providing load versus elonga-tion data until point of rupture shall be used.6.2.3 The error of the machine shall not exceed 1 % at anyreading within its loading range. Refer to Practices E4 fordetermining accuracy of the a
26、pparatus6.2.4 It shall be outfitted with a compression cell. Thetesting machine may be configured with the compression cell2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
27、fer to the standards Document Summary page onthe ASTM website.FIG. 1 Specimen Support Assembly (Two needed)F2878 102on the upper arm. The compression cell shall have a rangesufficient to penetrate the specimen.6.3 Hypodermic Needle Puncture Probes General Descrip-tion:6.3.1 All probes shall be fabri
28、cated from 304 stainless steelwith a Rockwell C Hardness of 35 to 40.6.3.2 All probes shall be: three-facet, regular bevel, regularwall hypodermic needles. Technicians may select from thefollowing gauges:6.3.2.1 28 gauge, 12.7-mm needle length (see Fig. 2a)6.3.2.2 25 gauge, 25.4-mm needle length (se
29、e Fig. 2b)6.3.2.3 21 gauge, 38.1-mm needle length (see Fig. 2c)6.3.2.4 Becton Dickinson model numbers BD 309309 (28g,12-in. long), BD305125 (25g, 1-in. long) and BD 305167 (21g,112-in. long) have been found to be suitable, though needlesfrom other sources which conform to the general description(6.3
30、.1-6.3.2) and perform within the range described in the lotvalidation table below may be used.6.4 A total of twelve puncture probes, selected from needlelots that have been validated, are required (one for eachpuncture measurement) to conduct the test.6.5 Specimen Support Assembly shall consist of t
31、wo flatmetal specimen support plates that clamp together so thesample specimen is held tightly between them. Care should betaken to lay specimens flat in the assembly without distortionor tension on the specimen. It shall also consist of a machineinterface plate that can be connected to the testing
32、machine.There should be enough distance to allow for at least 25 mm oftravel of the probe. The plates should be closed tightly on thespecimen to reduce slipping/shifting of the material betweenthe plates during testing to the greatest extent possible.6.5.1 Each plate shall have one or more puncture
33、guideholes measuring 10 to 25.4-mm diameter. Ideally, for efficiencyin testing, the plates may have three 10-mm diameter punctureguide holes. The holes should be spaced equally on the platewith each hole forming the points of a 60 equilateral trianglecentered on the plates as shown in Fig. 2.6.5.2 T
34、he two specimen support plates shall be connected tothe testing machine using a machine interface plate.NOTE 1Needle holders which allow the hub of the needle to beslipped over the end of the needle holder for a tension fit and needleholders with a screw down chuck (as used on a dissecting needle) w
35、hichrequire the needle to be cut from the hub and inserted into the end clamphave both been used successfully.6.6 It is important to ensure the needle mounting techniquebeing used securely holds the needle at a 90 anglerelative to the surface of the test specimen throughout the testprocedure. The cl
36、amp or mounting post should allow theproper length of the needle to remain exposed during testing.(see 6.3.2.1-6.3.2.4)6.7 Calibration Material shall be: polychloroprene film,Thickness 1.57 6 0.05 mm (0.062 in.), hardness (Shore A) 506 5, tensile strength 1200 psi min, ultimate elongation 300 %min,
37、specific gravity 1.4.6.7.1 Specification for calibration material is based onTrelleborg Coated Systems US, Inc. (formerly Reeves Broth-ers) part number: REEVES NS 5550.37. Test Specimen7.1 Four square test specimens, 8.9 by 8.9 cm each, shall beprepared. Cut holes through the specimens to accommodat
38、especimen support assembly fasteners.7.2 Test specimens should be conditioned prior to testing inaccordance with Practice D1776.8. Calibration8.1 Each lot of hypodermic needles shall be validated.8.2 Needle lot validation procedure8.2.1 Identify manufacturers lot number on the needlepackaging.8.2.2
39、Randomly select seven needles from the same manu-facturing lot and conduct seven puncture measurements on thecalibration material as described in Section 9.3The sole source of supply of the material known to the committee at this timeis Gindor, Inc. of Goshen, IN, Tel: 5746424004, http:/. If youare
40、aware of alternative suppliers, please provide this information to ASTMInternational Headquarters. Your comments will receive careful consideration at ameeting of the responsible technical committee,1which you may attend.FIG. 2 (a) Needle-tip Geometries (28G Needle Configuration)F2878 1038.2.3 If th
41、e average of the puncture measurements fallwithin the range specified on Table 1, needles from this lot areacceptable for data collection and reporting. If the average ofthe puncture measurements does not fall within the rangespecified in Table 1, needles from this particular lot can not beused to c
42、onduct this test.9. Procedure9.1 Measure the thickness of each specimen to the nearest0.01 mm and record.9.2 Mount the material specimen to be tested in the supportassembly. Mark the two plates and take care that the holes arealigned prior to testing to avoid damaging the penetrometer andplates.9.3
43、Attach the material support assembly to the upper orlower arm of the test apparatus depending on machine con-figuration.9.4 Position a fresh needle (from a lot of needles validatedas described in Section 8) on the compression cell of the testapparatus. Compression test machines require the cross hea
44、d totravel some distance before reaching the set velocity. Ensurethe tip of the needle is set back far enough from the surface ofthe test specimen to allow the cross head to build up to thedesired velocity prior to impacting the test specimen.9.5 Set the testing machine in operation, but stop it whe
45、n thepenetrometer has been driven through the sample specimen.The penetrometer shall have a velocity of 500 mm/min underload conditions and shall be uniform at all times.FIG. 2 (b) Needle-tip Geometries (25G Needle Configuration) (continued)FIG. 2 (c) Needle-tip Geometries (21G Needle Configuration)
46、 (continued)TABLE 1 Lot Validation Table for NeedlesNeedleGaugeAvg. PeakForce Target (N)Tolerance(6)StandardDev. (max)28 0.822 0.189 0.10525 1.134 0.17 0.11521 1.538 0.251 0.158F2878 1049.6 Record the maximum force registered by the indicatingdevice to the nearest 0.01 N.9.7 If the needle buckles pr
47、ior to penetration, record thepeak force loaded on the specimen prior to buckling.9.8 After the first test is complete, dispose of the usedneedle in a puncture proof sharps disposal container, mark thespot on the test specimen where the puncture occurred, mounta fresh needle, and repeat the test.9.8
48、.1 Multiple punctures may be conducted on a single testspecimen. When conducting multiple punctures, ensure holesfrom previous punctures are located outside of the punctureguide hole.9.9 Conduct a total of twelve puncture resistance measure-ments. The same type of needle (21, 25, or 28 gauge) should
49、 beused in each of the twelve measurements.10. Report10.1 Report the following information:10.1.1 Describe the type of material tested including thethickness of each specimen to the nearest 0.01 mm and whichside of material was facing needle. Calculate and report theaverage thickness.10.1.2 Report the gauge, manufacturer, part number and lotnumber for needles used in the test including length protrudingfrom the clamp or hub.10.1.3 Report the maximum force required for each punc-ture to the nearest 0.01 N in all twelve test replicates.10.1.4 Calculate a
