1、Designation: D3475 11Standard Classification ofChild-Resistant Packages1This standard is issued under the fixed designation D3475; 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 i
2、ndicates the year of last reapproval. Asuperscript epsilon () 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-incl
3、usive, 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 by
4、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, b
5、ut 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 time
6、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 products
7、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 packages
8、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 op
9、ened 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 no
10、n-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, po
11、wders, 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-resistantpackage
12、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. C
13、hild-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 ind
14、ication of whetheror not it has been successfully tested in accordance with theaforementioned guidelines.1This classification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Packaging.Current e
15、dition approved April 1, 2011. Published May 2011. Originallyapproved in 1976. Last previous edition approved in 2009 as D3475 09. DOI:10.1520/D3475-11.2Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.Available from U.S. Government Printing Office Superintendent of Documents,
16、 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.3.4 Additions or deletions to the examples should be re-ported to Committee D10 on Packaging, for
17、incorporation intothis classification during the next revision.4. Basis of Classification4.1 The basis for classification for child-resistant closure,and the classifications themselves, appear in Table 1.TABLE 1 Classification of Child-Resistant PackagesDescription ExampleTYPE I RECLOSABLE PACKAGING
18、CONTINUOUS THREAD CLOSUREA Random push down while turning; no orientation of the push down forcenecessaryKerr CR-I, II, III, IV and CRTE; Rexam Clic-Loc III, Argus-Loc, Chem-Loc, Ultra-Loc; Alcoa Tot-Gard III; Van Blarcom metal-on-metal, Saf-Cap I, II, III, andIIIA; Ferdinand Gutman; Poly Seal Corp.
19、; Reliable Products; Rexam F.G.(Final Generation), Carow-Turnloc; Comar-Secure Cap; Reike-FS652; CCLContainer Corporaton (tube) Van Blarcom Closures Inc. Dropper Closure, Saf-Cap Convertible, 1-1/8 BetaClosure; Bericap North America, Bericap SK28/26 CR Slitband; Sanner ofAmerica, Child Resistant Scr
20、ew Cap; Mold-rite Plastics CRC Pictorial ScrewCap, PDT Push Down the force must be applied to adesignated location on the closure skirtRexam Squeeze-Lok, Snap-Lok II, Econo-Lok, DOT, DoughertyBrothers; Fastex; Rexam Squeeze and Turn; Berry Plastics-Squeeze Weatherchem-Top Squeeze; Kerr-Tab II Squeez
21、e Rieke FS633, HZ43CR, HZ24CR; US Can-Screw top; Rexam Inc. Drain BackSystem; Rexam Jigger, Snap-Lok II, Squeeze Lok Low Profile; RiekeCorporation Stolz HZ32CR; Val-Pak Products, 63-400 Squeeze CapC Random squeeze while turning; no orientation of the squeeze force isnecessaryD Holding a fitment whil
22、e 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 necessaryG Localized lift of cap sk
23、irt 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; RexamI Set combination before turning None at this timeJ Pull tab then tur
24、n Intermova Gate Lok, Lefty LokK Align arrows, then push tab down, then turnL 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 applied to designated place onclosureU S Can Comp
25、any-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; Rexam Screw Loc; Kerr CR-V Thornton Plastics Tot-Lok; Child Related Research, Inc.Push-Palm; Desi
26、gn Consultant Plastics; Inventive Packaging Corp., ClarkeContainer Push Cebal Americas (tube) Rexam Inc. Purse Pak; Rexam, Spring-LocB Hold fitment down while turning closure Rexam Snap-Lok, Econo-Lok; Rexam-1-ClikC Unlock outer ring to release lugs Thornton PlasticsD Depress fitment and slide to on
27、e 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 PACKAGINGSNAP CLOSUREA(1) Align two points then
28、push up on tab or lip Bristol-Myers; Calmar Snap Safe; Stull; Plastic Research; Henlopen Snap Cap;Lermer CR Snap; Central States Can Co.;Boyle Midway; Clarke Container Snap Lok; VH Technologies-virtual hinge(2) Rotate then lift Continental Carlisle Co. Unikon; Magenta Corp.-PillpackB Localized downw
29、ard 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; Polytop ToggLoc Dispensing Closure(2) Press to release, follo
30、w by lifting force on tab (removable cap) Wheaton Industries Ryles Closure; 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, to release Shellvick Industries, Inc.(5) Pull to release and lift hinged li
31、d (dispensing cap) Stull Technologies: StullSURE(6) Push in and flip up CSP Technologies, ACTIV-VIAL(7) Push in and up then flip up CSP Technologies, Mini Cooper VialE(1) Squeeze and lift two specific points simultaneously Pennwalt-Lye; J. L. Clark; Rexam Flip-LokD3475 112TABLE 1 ContinuedDescriptio
32、n Example(2) Squeeze and lift one specific point simultaneously(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 thir
33、d side while lifting lidShaw-Clayton Press N Pop; Norman 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; Ker
34、r Glass Pry Off; Genpak Corp. Pry Off;Cin-Made Corporation (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 Dispensi
35、ng Nozzle ClosureH 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 secon
36、d index, 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.; Sha
37、rp; American 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
38、at this 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 productwithout human conta
39、ctTYPE 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 H
40、old fitment 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 pressedF Directional overcap-actuator requires sequential simultaneous
41、pushing 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 (actuate
42、s normally)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 C
43、orp.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
44、-RECLOSABLE 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) Remo
45、ve 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
46、; Constantia 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) Sh
47、arp 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 SharpATYPE IX DISPENSERS (NOT INTENDED TO BE REMOVED)BA Finger pump(1) Directional pump must
48、 be oriented (by rotation to a second stop position)then pumped with finger(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 System(3) Line-up arrows on the overcap and ri
49、ng 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 triggerContinental AFA Dispensing Co., 0176 CR; MeadWestvaco Calmar, Mixor HP;Guala Dispensing S.p.A., TS3 CRP Screw and Snap-on Versions; SprayPlast S.P.A. Vela CR(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 trigger(4) Press in and pull down to release lock and squeeze trigger
