1、Designation: D 3475 08Standard Classification ofChild-Resistant Packages1This standard is issued under the fixed designation D 3475; 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
2、 indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This classification covers various types of child-resistantpackages.1.2 The examples for each type of child-resistant packagingare not intended to be all-i
3、nclusive, but are included only as anaid in the understanding and comprehension of each type ofclassification.1.3 Listings are not to be considered endorsements orapproval of the package by ASTM.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 child-resistant packageas defined
4、by the PoisonPrevention Packaging Act, packaging that is designed orconstructed to be significantly difficult for children under fiveyears of age to open or obtain a toxic or harmful amount of thesubstance contained therein within a reasonable time, and notdifficult for normal adults to use properly
5、, but does not meanpackaging which all such children cannot open or obtain atoxic or harmful amount within a reasonable time.22.1.2 unit dose packagean immediate product container/package designed and labeled in such a manner that eachindividual product package is intended to be opened or usedone ti
6、me in a generally non-reclosable or non-resealablemanner, separately from the other individual product units inthe package, or the entire contents of a single unit packageintended for use in one application.2.1.2.1 DiscussionNormally used for pharmaceutical, hu-man healthcare, and nutritional produc
7、ts in dry solid, topical,transdermal, or liquid form.Aunit of sale package may containone or more individual unit dose packages, that is, individuallywrapped transdermal patches, pre-filled syringes and syringecartridges, blister cards with multiple tablets or capsules, andso forth. Unit dose packag
8、es may or may not be child-resistantin accordance with the regulatory requirements of the packagecontents.2.1.3 unit use/single use packagean immediate productcontainer/package, which may include label directions for use,designed in such a manner that each individual productpackage is intended to be
9、 opened or used one time separatelyfrom the other individual product units in the package, or theentire contents of a single unit package intended for use in oneapplication.2.1.3.1 DiscussionThese packages are generally non-reclosable or non-reusable. A unit of sale package may consistof one or more
10、 non-reusable individual packages. Generallyused for household, automotive, chemical, pesticide, veteri-nary, garden and other products not intended for humaningestion. Package styles may include some aerosol, that is,foggers, soluble film, canisters, pouches, and so forth, filledwith liquids, drys,
11、 powders, and other product forms. Packagesmay or may not be child-resistant in accordance with theregulatory requirements of the package contents.3. Significance and Use3.1 This classification scheme defines the type of motions,skills, or tools required for a particular type of child-resistantpacka
12、ge and provides examples of current packaging withinthat type.3.2 Reference to a particular package in this classification isnot intended in any manner to denote endorsement or approvalof the package by ASTM.3.3 Packages have been included as examples based onmanufacturers claims of child-resistance
13、. Child-resistantpackage functionality for any specific product type must bedetermined by the packager/manufacturer following the guide-lines of the PPPA of 1970 and the most current version of theCFR Title 16 Part 1700 and Title 40 Part 157.2The listing ofa package in this classification is not an
14、indication of whetheror not it has been successfully tested in accordance with theaforementioned guidelines.3.4 Additions or deletions to the examples should be re-ported to Committee D10 on Packaging, for incorporation intothis classification during the next revision.4. Basis of Classification4.1 T
15、he basis for classification for child-resistant closure,and the classifications themselves, appear in Table 1.5. Keywords5.1 child-resistant; child-resistant packaging1This classification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10
16、.31 on ChildResistant Packaging and Closure Systems.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1976. Last previous edition approved in 2007 as D 3475 07.2Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.Available from U.S. Government Pri
17、nting Office Superintendent of Documents, 732N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.TABLE 1 Classification of Child-Resistant PackagesDescrip
18、tion ExampleTYPE I RECLOSABLE PACKAGINGCONTINUOUS THREAD CLOSUREA Random push down while turning; no orientation of the push down forcenecessaryKerr CR-I, II, III, IV and CRTE; O-I Clic-Loc I, II, and III, Argus-Loc I and II andChem-Loc; Alcoa Tot-Gard III; Van Blarcom metal-on-metal, Saf-Cap I, II,
19、 III,and IIIA; Ferdinand Gutman; Poly Seal Corp.; Reliable Products; Rexam F.G.(Final Generation), Carow-Turnloc; Comar-Secure Cap; Reike-FS652; CCLContainer Corporaton (tube) O-I Inc. Ultra-Loc; Van Blarcom Closures Inc. Dropper Closure, Saf-CapConvertible, 1-1/8 Beta Closure; Bericap North America
20、, Bericap SK28/26 CRSlitband; Sanner of America, Child Resistant Screw CapB Localized squeeze force while turning; the force must be applied to adesignated location on the closure skirtRexam Squeeze-Lok, Snap-Lok, Econo-Lok, Tip Lok, DOT, DoughertyBrothers; Fastex; O-I Squeeze and Turn, Tab-Loc; Ber
21、ry Plastics-Squeeze Weatherchem-Top Squeeze; Kerr-Tab II Squeeze Rieke FS633, HZ43CR, HZ24CR; US Can-Screw top; O-I Inc. DrainBack System; Rexam Closures Rieke Corporation Stolz HZ32CR; Val-Pak Products, 63-400Squeeze CapC Random squeeze while turning; no orientation of the squeeze force isnecessary
22、O-ID Holding a fitment while turning; two-handed operation is normally required Thomas Closure Moldcraft; M Berry Plastics,Lite-TouchE Key or device required to open Research and Devices; Ben King Associates Baby Safe; TredegarF Random lift while turning; no orientation of the lift force is necessar
23、yG Localized lift of cap skirt or tab on closure while turning Charles A. Breskin; Alcoa Tot Gard IIH Localized push down while turning; force must be applied to a designatedplace on the top of the closureMack Wayne Plastics; Anchor Hocking Mold Craft; O-II Set combination before turning None at thi
24、s timeJ Pull tab then turn Intermova Gate Lok, Lefty LokK Align arrows, then push tab down, then turn O-I Cognitive ClosureL Turn closure until stops, then lift and continue trying to open Berry Plastics Corp.-pail; Berry Plastics Corporation ZH05SQM Localized push in while turning, force must be ap
25、plied to designated place onclosureU S Can Company-pailN Localized push back lever while turning, force must be applied to designatedplace on closureNone at this timeO Turn the top cap until stops, then push down and turn M Pac-Tec Inc.-Palm-N-Turn; O-I Screw Loc; Kerr CR-V Thornton Plastics Tot-Lok
26、; Child Related Research, Inc.Push-Palm; Design Consultant Plastics; Inventive Packaging Corp., ClarkeContainer Push Cebal Americas (tube) O-I Inc. Purse Pak; O-I, Spring-LocB Hold fitment down while turning closure Rexam Snap-Lok, Econo-Lok, Tip Lok; O-I-1-ClikC Unlock outer ring to release lugs Th
27、ornton PlasticsD Depress fitment and slide to one side Plastic box with sliding lug lock (manufacturer unknown); Creative PackagingLok-PakE Holding of fitment while turning; two-handed operation is normally requiredand no orientation of holding force is specifiedNone at this timeTYPE III RECLOSABLE
28、PACKAGINGSNAP CLOSUREA(1) Align two points then push up on tab or lip Bristol-Myers; Calmar Snap Safe; Stull; Plastic Research; Henlopen Snap Cap;Lermer CR Snap; O-I Snaploc; Central States Can Co.;Boyle Midway; Clarke Container Snap Lok; VH Technologies-virtual hinge(2) Rotate then lift Continental
29、 Carlisle Co. Unikon; Magenta Corp.-PillpackB Localized downward pressure to open Polymold; Basic Products Poly MoldC Downward pressure on top with simultaneous upward pull on edges Versatile Ind. ProductsD(1) Press to release and then lift hinged tab (dispensing cap) Magenta Corp.; Lumlite PopLok;
30、Polytop ToggLoc Dispensing Closure(2) Press to release, follow by lifting force on tab (removable cap) Wheaton Industries Ryles Closure; O-I hood type, Magenta Corp. Pop-Lok Plug(3) Push up to release Stull Easy Flip 2008 captive hinge; Stull Technologies, Pry Open Closure(4) Push in or up, or both,
31、 to release Shellvick Industries, Inc.(5) Pull to release and lift hinged lid (dispensing cap) Stull Technologies: StullSURE(6) Push in and flip up CSP Technologies, ACTIV-VIALE(1) Squeeze and lift two specific points simultaneously Pennwalt-Lye; J. L. Clark(2) Squeeze and lift one specific point si
32、multaneously(3) Squeeze two points simultaneously to open MAC Closures Inc.; FTCR 19000, FTCR 19100, FTCR 19500; Philips RxPackaging LLC, Rx Squeeze VialF Squeeze two specific points simultaneously to unlock sides, then squeezespecific point on third side while lifting lidShaw-Clayton Press N Pop; N
33、orman J. LarusG Requires key device or fingernail or coin or other tool to open Skilcraft; Continental Plastics Med Guard; Plastic Container Corp. Prex Con;Polytop Corp. LokTop; Myco Corp. Surelock, Vicap; Rexam Snap Cap;Pin Lock, Inc. Pin Lock; Kerr Glass Pry Off; Genpak Corp. Pry Off;Cin-Made Corp
34、oration (container) CMI (closure) Tec Loc; Continental FibreDrum Leverpak; Berry Plastics; Plastican, Inc. Lever/Toggle Band on Pail;Container Products Inc. Lever Lok; Cin Made Corp. Friction Fit Plug; SilganPlastics Corporation 28MM-410 CR Dispensing Nozzle ClosureD3475082TABLE 1 ContinuedDescripti
35、on ExampleH Lift locking tab then push up Internova Corp. Flap LokI Random squeeze while turning and pulling up Stull Snap On/Twist OffJ Align two points, push down outer ring, then push up tab or lip Robert Linkletter AssociatesK Rotate cap to a first index, then counterrotate cap to a second index
36、, thenlift capYellowstone Environmental Science, Inc. WiseCapTYPE IV UNIT NON-RECLOSABLE PACKAGINGFLEXIBLE (STRIP/POUCH)A Internal (hidden) tear notch Sharp; Reynolds Aluminum (Safety Pak 101); PCM Corp.; Cardinal Health;West Pharma-Services; Reed-Lane, Inc.B Oriented tear Schering Corp.; Sharp; Ame
37、rican National Can Co.; Reed-Lane, Inc.C Requires tool Hargo Flexible Packaging (Pos-I-Pak); Sharp; Hach Chemical Co.;American National Can Co.; Cardinal Health;Paco; Reed-Lane, Inc.; PactechTYPE V UNIT NON-RECLOSABLE PACKAGINGRIGIDA Requires tool All metal canB Requires localized force None at this
38、 timeC Peelable backing or coating Standard packagingPackage is not opened or activated to expose contents: (1) One piece plasticunit with multiple holes to allow use of product without human contact; and (2)Two piece plastic unit with multiple holes to allow use of product withouthuman contactTYPE
39、VI UNIT RECLOSABLE PACKAGEA Metered device None at this timeTYPE VII AEROSOL PACKAGESA Localized squeeze while lifting removes overcap (actuates normally) Knight Engineering; Berry Plastics; Cobra Plastics Inc. 65 mm NICRB Hold fitment still while turning (actuates normally) Thomas ClosureC Hold fit
40、ment still while lifting (actuates normally) None at this timeD Requires use of a key or device to open (actuates normally) Newman Green, Shellvick Answer Cup 200 TR/CRE Directional overcap-actuator must be oriented, then pressed O-IF Directional overcap-actuator requires sequential simultaneous pus
41、hing oflocking device and actuatorUnion Carbide; Seaquist; Rexam CR AerosolG Directional overcap-actuator which requires a finger longer than that of a child Shell ChemicalH Press to release, lift hinged tab at center of the closure followed by an upwardforce on the tab to remove overcap (actuates n
42、ormally)None at this timeI Directional overcap-actuator that requires the lifting of a hinged tab to revealthe actuatorNone at this timeJ Random push down while turning; no orientation of the downward force isnecessaryITL (Hayes-Albion)K Localized press down then pull up at arrow Berry Plastics Corp
43、.L Localized push up to remove Berry Plastics Corp.M Line-up arrows on the overcap and ring to remove Magenta Corporation (design by Innopak) Airsafe; Pierson Industries Inc.(Contact Technimark Associates) Hold Collar Line up Arrows Safety Closure,Universally Adaptable Safety ClosureTYPE VIII NON-RE
44、CLOSABLE PACKAGINGSEMI-RIGID (BLISTER)A Remove a portion(1) Remove portion (tab) and peel back Sharp; Merial Ltd., Child-Resistant Blister Pack(2) Remove portion (tab), peel back, and push out Sharp(3) Remove portion (tab) and push out Meadwestvaco, PerfPak; Howell Packaging, Howel-CR-III(4) Remove
45、portion (tab), rotate the blister to orient, push through Colbert, PharmaDial(5) Push to expose tab, peel back tab, push out Keystone Folding Box Co., Key-Pak F1; Sharp Corporation AdvantagePak(6) Zipper card-pull back card strip behind tablet and push out Sharp Ivers-LeeB Peel(1) Peel back Sharp; C
46、onstantia Hueck Folien(2) Peel back and push out Sharp; Proclinical, Pick and Peel; Constantia Hueck FolienC Bend(1) Center bend Sharp(2) Bend, peel off, peel back, and push out Sharp(3) Bend, peel back, push out Intini Marketing, Bend Cardinal Health, E-Z tear(2) Internal tear notch (visible) Sharp
47、 Ivers-LeeE Push Out(1) Push out Sharp; Cardinal Health RxBarrier Pack(2) Press-in and push-out MeadWestvaco, PIPO Pack(3) Push-pull-push out Alcan Packaging, Generation IIF Requires Tool(1) Requires tool SharpAD3475083TABLE 1 ContinuedDescription ExampleTYPE IX DISPENSERS (NOT INTENDED TO BE REMOVE
48、D)BA Finger pump(1) Directional pump must be oriented (by rotation to a second stop position)then pumped with fingerO-I(2) Push tab while rotating directional pump to spray position, then pump withfingerPackaging Concepts Association, LLC CR Mpak; Packaging Concepts Assoc.,LLC, Snap-on Dispensing Sy
49、stem(3) Line-up arrows on the overcap and ring to remove Duerr (design by Innopak), AirsafeB Trigger pump(1) Press down on a point to release lock, rotate orifice to spraying position,and squeeze triggerO-I; Continental AFA Dispensing Co., 0176 CR; MeadWestvaco Calmar, MixorHP; Guala Dispensing S.p.A., TS3 CRP Screw and Snap-on Versions(2) Press in and up on orifice (lock cover) and squeeze trigger AFA Corp.(3) Push down on a point and slide it back to release lock, then rotate theorifice to the spraying position, and squeeze triggerSpray Plast S.P.A. Vela CR(4) Press in an
