1、Designation:F213201(Reapproved 2008)1Standard Specification forPuncture Resistance of Materials Used in Containers forDiscarded Medical Needles and Other Sharps1This standard is issued under the fixed designation F2132;the number immediately following the designation indicates the year oforiginal ad
2、option 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.1NOTEEditorial changes were made throughout in June 2008.1.Scope1.1 The purpose of this
3、specification is to provide a testprocedure 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 fo
4、rce that container materi-al(s)must withstand 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
5、shall be considered“puncture-resistant.”This specification does 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 n
6、ot define the number ofadditional 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 factor
7、s,such as end-user require-ments.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 mater
8、ial puncture resistance atnormal room temperatures.Applications of sharps containersoutside the range of 23 6 2C(such as usage in emergencyvehicles)require further material characterization by the prod-uct specifier to determine suitable use.)1.4 The values stated in inch/pound are to be regarded as
9、 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.It is therespons
10、ibility 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:2E691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Metho
11、d2.2 ISO Standards:ISO 7864 Sterile Hypodermic Needles for Single Use3ISO 594 Luer Fittings32.3 Other Standards:AS 4031:1992 Non-reusable Containers for the Collection ofSharp Medical Items Used in Health Care Areas4BSI 7320:1990 Specification for Sharps Containers5CSA Z316.6-95 Evaluation of Single
12、 Use Medical SharpsContainers for Biohazardous and Cytotoxic Waste6DHHS(NIOSH)PublicationNo.97-111 Selecting,Evaluating,and Using Sharps Disposal Containers71This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibili
13、ty ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Feb.1,2008.Published March 2008.Originallyapproved in 2001.Last previous edition approved in 2001 as F2132 01.DOI:10.1520/F2132-01R08E01.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM
14、 Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,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
15、Australia International Ltd.,286 Sussex St.,Sydney,Australia NSW 2000.5Available 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 P
16、ublications Dissemination,EID National Institute for Occu-pational Safety and Health,4676 Columbus Pkwy.,Cincinnati,OH 45226-1998.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 Definitions:3.1.1 containera product used for the containment ofdiscarded medical needles and other sharps.3.1.2 materialthe substance(s)used in the construction ofa sharps container.3.1.3 puncture forcethe minimum force applied to therepresen