1、Designation: F 2132 01 (Reapproved 2008)Standard Specification forPuncture Resistance of Materials Used in Containers forDiscarded Medical Needles and Other Sharps1This standard is issued under the fixed designation F 2132; the number immediately following the designation indicates the year oforigin
2、al 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.1. Scope1.1 The purpose of this specification is to provide a testprocedure
3、and performance requirement for the punctureresistance of materials used in the construction of containersfor discarded medical needles and other sharps. This testspecification will establish (1) the average puncture force and(2) a minimum value of puncture force that container materi-al(s) must wit
4、hstand when following the test procedure de-scribed in Section 6. This specification shall be applicable toregions of uniform material and thickness, and needle contactareas as defined in 3.1.7 and 3.1.9. Materials meeting theperformance requirements of Section 4 will be considered“puncture resistan
5、t.” This specification will not evaluate theconstruction of, or provide pass/fail criteria for, a sharpscontainer.1.2 This specification provides a test procedure to determineif all regions of one container meet the material punctureresistance requirements. It does not define the number ofadditional
6、 test containers required to achieve a statisticallyvalid sample of a manufacturing lot or process. An appropriatesampling plan shall be determined by the test requester, as thisdepends upon the manufacturing process variability, manufac-turing lot size, and other factors, such as end-user require-m
7、ents.1.3 This specification is intended to evaluate the perfor-mance of materials used in the construction or manufacture ofsharps containers under controlled laboratory conditions, andat normal room temperature (see 6.1). (WarningThis speci-fication only characterizes material puncture resistance a
8、tnormal room temperatures. Applications of sharps containersoutside the range of 23 6 2C (beyond the clinical environ-ment, such as usage in emergency vehicles), require furthermaterial characterization by the product specifier to determinesuitable use.)1.4 The values stated in inch/pound are to be
9、regarded as thestandard. The SI values given in parentheses are for informa-tion only.1.5 The following hazard caveat pertains only to the testprocedure portion, Section 6, of this specification.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use.
10、 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:2E 691 Practice for Conducting an Interlaboratory Study toDetermine the Precis
11、ion of a Test Method2.2 ISO Standards:ISO 7864 Sterile Hypodermic Needles for Single Use3ISO 594 Luer Fittings32.3 Other Standards:AS 4031:1992 Non-reusable Containers for the Collectionof Sharp Medical Items Used in Health Care Areas4BSI 7320:1990 Specification for Sharps Containers5CSA Z316.6-95 E
12、valuation of Single Use Medical SharpsContainers for Biohazardous and Cytotoxic Waste6DHHS (NIOSH) Publication No. 97-111 Selecting, Evalu-ating, and Using Sharps Disposal Containers73. Terminology3.1 Definitions:3.1.1 containera product used for the containment ofdiscarded medical needles and other
13、 sharps.3.1.2 materialthe substance(s) used in the construction ofa sharps container.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition
14、 approved Feb. 1, 2008. Published March 2008. Originallyapproved in 2001. Last previous edition approved in 2001 as F 2132 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information,
15、 refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from Standards Australia International Ltd., 286 Sussex St., Sydney,Australia NSW 2000.5Available
16、 from British Standards Institute (BSI), 389 Chiswick High Rd.,London W4 4AL, U.K., http:/www.bsi-.6Available from Canadian Standards Association, Andre Wisaksana, 178Rexdale Blvd., Etobicoke, ON Canada M9W 1R3.7Available from Publications Dissemination, EID National Institute for Occu-pational Safe
17、ty and Health, 4676 Columbus Pkwy., Cincinnati, OH 45226-1998.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.3 puncture forcethe minimum force applied to therepresentative sharp object that causes its tip to penetrate (exit)the
18、opposite side of the test specimen from the side that itentered when tested in accordance with the test procedureportion, Section 6, of this specification.3.1.4 puncture resistanta region of uniform material andthickness is defined as puncture resistant if it meets Section 4of this specification whe
19、n tested in accordance with Section 6of this specification.3.1.5 test specimena sample of material being evaluatedfor puncture resistance that is taken from the actual container(direct method) or a representative example of the material andthickness having the same characteristics as the actual con-
20、tainer (indirect method). Refer to Section 5.3.1.6 puncture test specimena test specimen that has beenpunctured using the puncture test described in 6.3, and subse-quently evaluated using the direct or indirect methods de-scribed in 7.1 and 7.2 of this specification.3.1.7 region of uniform material
21、and thicknesssharps-contact areas of the container, in aggregate, that are made of thesame homogeneous, composite, or laminated material, and, asa consequence of fabrication or design or both, are expected tohave the same material and thickness as compared to otherareas of the container. For example
22、, in molded containers, thecorners could be expected to be of different thickness than thesides and bottom, resulting in different regions of uniformmaterial and thickness. Labels, tabs, membranes, or thin filmscovering openings in the container are considered separateregions of uniform material and
23、 thickness.3.1.8 sharpsitems used in medical treatment, diagnoses,or research that may cause puncture wounds, cuts, or tears inskin or mucous membranes, including, but not limited to:hypodermic, surgical, suture, and IV needles; Pasteur pipets,lancets, razors, scalpels, and other blades and sharp ob
24、jects.3.1.9 sharps-contact areasthe material of a container thatrepresents those surfaces that enclose sharps within the con-tainer, when in its final closure configuration (that is, disposalconfiguration).4. Performance Requirements4.1 Puncture Resistance SpecificationWhen tested in ac-cordance wit
25、h Section 6, the average puncture force to pen-etrate material test specimens representing any regions ofuniform material and thickness and sharps-contact areas, asdefined in Section 3, shall not be less than 3.4 lbf (15 N), withno one value from any region of material tested less than 2.8lbf (12.5
26、N).4.2 Layered Materials and LinersIf a container is de-signed to use nonlaminated layers of material in sharps-contactareas, the combination of these layered materials must betested as configured in actual use, and meet the punctureresistance specification of this standard to be deemed punctureresi
27、stant. If a container is designed to use a removable linerenclosed by the container, the material used in the removableliner must meet the puncture resistance specification of thisstandard to be deemed puncture resistant.For example, layered materials must be tested with the samespacing as configure
28、d in the actual application.5. Sampling and Specimen Preparation5.1 Direct Versus Indirect MethodEither of two testingprocedures may be used to demonstrate that the material ispuncture resistant under this specification. The direct method isto be used if the material being evaluated has unknownchara
29、cteristics. The indirect method may be used only if thematerial being evaluated has been previously characterized bya puncture force versus thickness relationship (see 7.2.2).5.1.1 Direct Method Specimen Preparation:5.1.1.1 One sharps container shall be selected at random torepresent the material(s)
30、 to be tested. If it is not possible toobtain the required number of test specimens from onecontainer, additional randomly selected containers shall besampled until the required number of test specimens is ob-tained.5.1.1.2 Identify each region of uniform material and thick-ness (see 3.1.7 and 3.1.9
31、). Mark each region with a grid of 1-in.(25.4-mm) squares until the entire region has been covered. Ifit is not possible to fit a 1-in. grid over certain areas of thecontainer, a smaller grid may be used; however, it shall be noless than 0.5 in. (12.7 mm) on a side.5.1.1.3 Number every square of the
32、 grid so that each regionof uniform material and thickness has consecutive numbers,starting with No. 1 in each region.5.1.1.4 Using a random-number generator or table, select aquantity of 1-in. (or 0.5-in.) square specimens equal to 10 % ofthe surface area of each region of the container as defined
33、in3.1.7 or no less than twelve specimens from each region. If atleast twelve specimens cannot be obtained from one container,refer to 5.1.1.1. Remove the specimens identified by therandom number selection from each region of the test con-tainer. Mark the test specimen as it is removed to identify th
34、einside of the container, as the puncture is required from theinside of the container outward.5.1.1.5 Measure, mark, and record the thickness at thecenter of each selected test specimen using a thickness-measuring device capable of measuring in 0.001-in. (0.025-mm) increments, with an accuracy of 2
35、% of the thicknessmeasured, for example, a ball micrometer with a ball diameterof 0.06 to 0.125 in. (1.6 to 3.2 mm). If the test specimenincludes a radius, corner, edge, or other design feature, find theminimum thickness and mark the location, if not in the centerof the specimen. Identify the specim
36、en as to material andthickness represented.5.1.1.6 Proceed to Section 6.5.1.2 Indirect Method Specimen Preparation:5.1.2.1 Obtain fabricated or molded test specimens (referredto as plaques within the indirect section) representing eachmaterial, range of thickness, and equivalent manufacturingprocess
37、 used to represent the sharps container. These plaqueswill not be from the container itself, but will be used tocorrelate the measured thickness of an actual container to thepuncture resistance value of plaques having the same charac-teristics.5.1.2.2 Produce a minimum of nine test plaques to repres
38、enta minimum of four different thicknesses that span the range ofthicknesses expected for each region of uniform material andthickness of the representative container. Select 9 test plaquesF 2132 01 (2008)2from a minimum of 4 thickness ranges for a minimum of 36specimens. The size of each prepared p
39、laque is to be deter-mined by 5.1.1.2.5.1.2.3 Measure and record the thickness at the center ofeach selected test plaque, using the same thickness measuringdevice as in 5.1.1.5, and identify the plaque as to material andthickness represented.5.1.2.4 Proceed to Section 6.6. Puncture Test Procedure6.1
40、 Conditioning:6.1.1 Condition all test specimens at 23 6 2C for 24 hbefore testing, unless the material is hydrophilic, requiring, inaddition, a 50 6 5 % relative humidity.6.1.2 Conduct tests under the same standard laboratoryconditions as that used for conditioning.6.2 Apparatus Requirements:6.2.1
41、Testing Machineany force-generating device ca-pable of operating a movable member at a constant rate ofmotion. The testing machine shall be calibrated according tothe manufacturers instructions.6.2.2 Crosshead Speed Controla drive mechanism forimparting to the movable member of the testing machine a
42、uniform, controlled velocity of 4 in./min (100 mm/min) withrespect to the fixed member.6.2.3 Load Indicatora load-indicating mechanism shallbe capable of measuring and recording force with an accuracyof 61 % of the measured test force.6.2.4 Representative Sharp Objectregular wall and bevel,Luer-type
43、 hypodermic needle, 21 gage by 1 in. (0.8 by 25.4mm) that meets ISO Standards 7864 and 594.6.2.5 Needle Holderany Luer-type fitting or other suitableholder that will attach the needle securely to the testingmachine or load indicator at an angle of 90 6 5 with respectto the test specimen.6.2.6 Specim
44、en Supporta block of any suitably rigidmaterial (aluminum, steel, wood, and so forth) conforming tothe dimensions of the block shown in Fig. 1.6.2.7 Puncture Sensing Deviceany device capable ofsensing when the needle tip just penetrates (exits) the oppositeside of the test specimen from the side whi
45、ch it enters, and,when used in conjunction with the load indicator, records theforce applied to the needle as its tip just penetrates (exits) thespecimen. Any mechanism or materials used to sense punctureshall not influence the test results.NOTE 1A suitable means of sensing puncture is to place a pi
46、ece ofthin metal foil secured with suitable adhesive on the side of the testspecimen corresponding to the outside of the container. The foil is wiredsuch that an event marker will indicate, on the load indicator, the forcebeing applied to the needle when it just penetrates the sample and touchesthe
47、metal foil. The foil must be in intimate contact with the test specimen(that is, no air bubbles). Suggested foil is 0.001-in.-thick aluminum foodwrap; suggested adhesive is household glue stick.6.3 Puncture Test:6.3.1 Prepare the testing machine and specimen support andset the crosshead speed veloci
48、ty to 4 in./min (100 mm/min).6.3.2 Affix a new needle to the needle holder. Zero the loadindicator to account for the weight of the holder and the needle.6.3.3 Secure the test specimen on the specimen support sothat the surface of the specimen corresponding to the insidesurface of the container (if
49、applicable) is facing toward, and isperpendicular to, the needle. Any securing mechanism used toaffix the specimen to the support shall not influence the testresults. The test specimen, as identified in 5.1.1.5, shall beplaced over the hole of the specimen support, with the area tobe punctured directly under the needle. Do not alter or distortthe configuration of the specimen. If the material is layered ora liner, refer to 4.2.6.3.4 Allow sufficient space between the needle and the testspecimen so that the movable member can attain the specifiedcr
