ASTM_D_3481_-_06_2011.pdf

Designation:D348106(Reapproved 2011)Standard Test Method forManual Shelling Two-Piece Child-Resistant Closures ThatAre Activated by Two Simultaneous Dissimilar Motions1This standard is issued under the fixed designation D3481;the number immediately following the designation indicates 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.1.Scope1.1 This test method covers the measurement of the forcerequired to separate(or“shell”)the snap-fitted outer cap fromthe inner cap of Type IA,IB,or IC child-resistant closures.1.2 This test method does not measure the force required toseparate parts of a child-resistant closure system that wereoriginally“screwed-on”instead of“snapped-on”(for example,pull a cap over or through continuous or multi-start threadswhen the cap was originally screwed on).1.3 The values stated in SI units are to be regarded as thestandard.The inch-pound units given in parentheses are forinformation only.1.4 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 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD3475 Classification of Child-Resistant PackagesE105 Practice for Probability Sampling of MaterialsE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or Process2.2 Other Documents:ISO Bulletin 2233 PackagingComplete,Filled,TransportPackagesPart 2:Conditioning for Testing33.Terminology(see Classification D3475)3.1 Definitions:3.1.1 Type IA child-resistant closurea two-piece continu-ous thread closure requiring a random push down whileturning;no orientation of the push down force is necessary.3.1.2 Type IB child-resistant closurea two-piece continu-ous thread closure requiring a localized squeeze force whileturning;the force must be applied to a designated location onthe closure skirt.3.1.3 Type IC child-resistant closurea two-piece continu-ous thread closure requiring a random squeeze while turning;no orientation of the squeeze force is necessary.4.Summary of Test Method4.1 This test method measures the force required to pry theouter cap off the inner cap using a fixture having a contact pointunder the tip of the skirt of the outer cap and leverage beingplaced on that point and the top of the cap.This procedure isused where a pivotal prying force can be successfully used toseparate the components of the closure system.Either a torquewrench or a torque meter can be used as a measuring device.5.Significance and Use5.1 This test method of applying force may be used as astandard test to compare the characteristics of a given design ofcontainer/child-resistant closure system with a standard or tocompare the characteristics of container/child-resistant closuresystems differing in construction.5.2 It may be used to simulate certain manipulations thatmay be expected to occur in protocol testing4(such as,pryingwith the teeth or objects in the room,biting,and pulling withthe teeth).5.3 This test method may be used to establish performancespecifications.6.Apparatus6.1 Testing Machine(s):1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical,Medical,and Child Resistant Packaging.Current edition approved Aug.1,2011.Published November 2011.Originallyapproved in 1976.Last previous edition approved in 2006 as D3481 06.DOI:10.1520/D3481-06R11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,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.4Consumer Product Safety Commissions Poison Prevention Packaging Act,1970.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.1.1 Torque Meter5with a scale that will read with themaximum point reading accuracy within the torque rangeexpected to be measured(for example,use a 0 to 25 T.I.P.torque meter for readings under 25 T.I.P.,not a 0 to 100 T.I.P.torque meter).6.1.2 Torque Wrench,of accepted design and capacity.6.2 Attachments,Fixtures,etc.(see Fig.1):6.2.1 Cap Holding Fixture with one contact point under thelip of the outer cap skirt and the other point contacting the topof the cap.The distance between the two contact points shouldbe 34 mm or approximately 138in.(in accordance with page19 of the Krogman study5)or