ASTM F2132-2001 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps《废弃医用针头和其它尖锐物用的容器使用的材料抗穿透性的标准规范》.pdf

1、Designation: F 2132 01Standard 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 oforiginal adoption or, in

2、 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 and performance re

3、quirement 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 withstand when follow

4、ing 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 resistant.” This specifica

5、tion 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 test containers r

6、equired 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-ments.1.3 This spec

7、ification 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 atnormal room tempe

8、ratures. 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 regarded as thesta

9、ndard. 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. It is theresponsi

10、bility 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:E 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Metho

11、d22.2 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 Evaluation of Singl

12、e 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 sharps.3.1.2 mate

13、rialthe substance(s) used in the construction ofa sharps container.3.1.3 puncture forcethe minimum force applied to therepresentative sharp object that causes its tip to penetrate (exit)the opposite side of the test specimen from the side that itentered when tested in accordance with the test proced

14、ureportion, Section 6, of this specification.3.1.4 puncture resistanta region of uniform material and1This 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

15、.Current edition approved Aug. 10, 2001. Published September 2001.2Annual Book of ASTM Standards, Vol 14.02.3Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.4Available from Standards Australia International Ltd., 286 Sussex St., Sydney,Australia NSW

16、 2000.5Available from British Standards Institute, 2 Park St., London, EnglandW1A2B5.6Available from Canadian Standards Association, Andre Wisaksana, 178Rexdale Blvd., Etobicoke, ON Canada M9W 1R3.7Available from Publications Dissemination, EID National Institute for Occu-pational Safety and Health,

17、 4676 Columbus Pkwy., Cincinnati, OH 45226-1998.1Copyright ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.thickness is defined as puncture resistant if it meets Section 4of this specification when tested in accordance with Section 6of this specification.3.1.5 test speci

18、mena 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-tainer (indirect method). Refer to Section 5.3.1.6 puncture test specimena

19、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 and thicknesssharps-contact areas of the container, in aggregate, that are

20、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, in molded containers, thecorners could be expected to be of different thi

21、ckness 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 thickness.3.1.8 sharpsitems used in medical treatment, diagnoses,or resear

22、ch 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 objects.3.1.9 sharps-contact areasthe material of a container thatrepresents

23、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 with Section 6, the average puncture force to pen-etrate material test specime

24、ns 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 N).4.2 Layered Materials and LinersIf a container is de-signed to use nonla

25、minated 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 punctureresistant. If a container is designed to use a removable linerenclosed by the c

26、ontainer, 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 configured in the actual application.5. Sampling and Specimen Preparation5.1 Direct

27、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 unknowncharacteristics. The indirect method may be used only if thematerial being evalu

28、ated 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) to be tested. If it is not possible toobtain the required number of test s

29、pecimens 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). Mark each region with a grid of 1-in.(25.4-mm) squares until the entire

30、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 grid so that each regionof uniform material and thickness has consecutive

31、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 in3.1.7 or no less than twelve specimens from each region. If atleast twelv

32、e 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 theinside of the container, as the puncture is required from theinside of the

33、 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 % of the thicknessmeasured, for example, a ball micrometer with a ball diam

34、eterof 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 specimen as to material andthickness represented.5.1.1.6 Proceed to Section 6.5.1

35、.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 used to represent the sharps container. These plaqueswill not be from the

36、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 representa minimum of four different thicknesses that span the range ofthicknesse

37、s expected for each region of uniform material andthickness of the representative container. Select 9 test plaquesfrom a minimum of 4 thickness ranges for a minimum of 36specimens. The size of each prepared plaque is to be deter-mined by 5.1.1.2.5.1.2.3 Measure and record the thickness at the center

38、 ofeach selected test plaque, using the same thickness measuringdevice as in 5.1.1.5, and identify the plaque as to material andF 21322thickness represented.5.1.2.4 Proceed to Section 6.6. Puncture Test Procedure6.1 Conditioning:6.1.1 Condition all test specimens at 23 6 2C for 24 hbefore testing, u

39、nless 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 Testing Machineany force-generating device ca-pable of operating a movable member at

40、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 auniform, controlled velocity of 4 in./min (100 mm/min) withrespect to the fixed membe

41、r.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 hypodermic needle, 21 gage by 1 in. (0.8 by 25.4mm) that meets ISO Standards 7864 an

42、d 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 Specimen Supporta block of any suitably rigidmaterial (aluminum, steel, wood, and so forth)

43、 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 which it enters, and,when used in conjunction with the load indicator, records theforce

44、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 piece ofthin metal foil secured with suitable adhesive on the side of the testspecimen

45、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 metal foil. The foil must be in intimate contact with the test specimen(that is, no a

46、ir 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 velocity to 4 in./min (100 mm/min).6.3.2 Affix a new needle to the needle holder. Zero the

47、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 applicable) is facing toward, and isperpendicular to, the needle. Any securing mechan

48、ism 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 th

49、e 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 specifiedcrosshead velocity before the needle penetrates the test speci-men. Start the drive mechanism.6.3.5 Stop the test after the cannula of the needle haspenetrated the sensing material on the side of the puncturespecimen opposite that side which it entered. If the needlecannot exit the puncture specimen, record that the needle didnot puncture.6.3.6 Record the puncture force of each puncture specimen,as def