ASTM D3475-2018 Standard Classification of Child-Resistant Packages.pdf

1、Designation: D3475 18Standard 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.1.4 This international standard was developed in accor-dance with internationally recognized principles on s

4、tandard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 child-resistan

5、t packageas defined 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 ad

6、ults to use properly, 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

7、opened or usedone time 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, an

8、d nutritional products in dry solid, topical,transdermal, or liquid form. A unit 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 f

9、orth. Unit dose packages 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 productpac

10、kage is intended to be 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

11、 consistof one or more non-reusable individual packages. Generallyused for household, automotive, chemical, pesticide,veterinary, garden and other products not intended for humaningestion. Package styles may include some aerosol, that is,foggers, soluble film, canisters, pouches, and so forth, fille

12、dwith liquids, dries, 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

13、 child-resistantpackage 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 claim

14、s of child-resistance. 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 clas

15、sification is not an indication of whether1This classification is under the jurisdiction of ASTM Committee F02 onPrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.50on Package Design and Development.Current edition approved April 15, 2018. Published June 2018. Originally

16、approved in 1976. Last previous edition approved in 2018 as D3475 18. DOI:10.1520/D3475-18.2Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.Available from U.S. Government Printing Office Superintendent of Documents, 732N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401,

17、 http:/www.access.gpo.gov.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles f

18、or theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1or not it has been successfully tested in accordance with theaforementioned guidelines.3.4 Additions or deletions to the examples should be re-

19、ported to Subcommittee F02.50 on Package Design andDevelopment, for incorporation into this classification duringthe next revision.3.5 Additions require F02.50 Task Group review of CFRTitle 16 Part 1700 full protocol testing reports. Reports shouldcover procedures and all CFR Title 16 Part 1700 requ

20、iredreporting elements. Additional information may be requested.3.6 Use of a package cited in this classification allows forthe statement “CONFORMS TO ASTM D3475,” and does notallow for the use of the ASTM logo or result in an ASTMcertification mark.4. Basis of Classification4.1 The functional basis

21、 for classification and the classifi-cations appear in Table 1.TABLE 1 Classification of Child-Resistant PackagesDescription 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; Ber

22、ry Global, Inc. Clic-Loc and Clic-Loc III,Argus-Loc, Ultra-Loc, Ultra-Loc “C”; Alcoa Tot-Gard III; Van Blarcom metal-on-metal, Saf-Cap I, II, III, and IIIA; Ferdinand Gutman; Poly Seal Corp.;Reliable Products; Berry Global, Inc. F.G. (Final Generation), Carow-Turnloc;Comar-Secure Cap; Reike-FS652; C

23、CL Container Corporaton (tube) Van Blarcom Closures Inc. DropperClosure, Saf-Cap Convertible, 1-1/8 Beta Closure; Bericap North America,Bericap SK28/26 CR Slitband; Sanner of America, Child Resistant ScrewCap; Mold-rite Plastics CRC Pictorial Screw Cap, PDT Push Down Drug Plastics GerresheimerBolesl

24、awiec S.A. NG 38C; Berry Global, Inc. CR-I/TEIII; Berry Global, Inc.CR-III; Berry Global, Inc. CR3A/LR; Berry Global, Inc. CR5; Berry Global, Inc.CR4; Berry Global, Inc. MAC DumaB Localized squeeze force while turning; the force must be applied to adesignated location on the closure skirtEcono-Lok,

25、DOT, Dougherty Brothers; Fastex; Berry Global, Inc. Squeeze andTurn; Berry Global, Inc.-Squeeze Weatherchem-TopSqueeze; Kerr-Tab II Squeeze Rieke FS633, HZ43CR, HZ24CR; USCan-Screw top; Squeeze Lok Low Profile, FG; Rieke Corporation StolzHZ32CR; Val-Pak Products, 63-400 Squeeze Cap; Berry Global, In

26、c. DOTSeries DCR; Berry Global, Inc. DOT Series DCR-TI; Berry Global, Inc. DrainBack System; Berry Global, Inc. Jigger; Berry Global, Inc. Quarter-Turn;Berry Global, Inc. Snap-Lok II; Berry Global, Inc. Squeeze and Turn; BerryGlobal, Inc. SQL; Berry Global, Inc. Tab II; Pollen, Double SqueezeC Rando

27、m squeeze while turning; no orientation of the squeeze force isnecessaryD Holding a fitment while turning; two-handed operation is normally required Thomas Closure Moldcraft; M Berry Global, Inc.Lite-TouchE Key or device required to open Research and Devices; Ben King Associates Baby Safe; TredegarF

28、 Random lift while turning; no orientation of the lift force is necessaryG 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; An

29、chor Hocking Mold Craft; Berry Global, Inc.I Set combination before turning None at this timeJ Pull tab then turn 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 Global, Inc.-pail; Berry Global, Inc. ZH

30、05SQ; Berry Global, Inc.T05SCR(B) Berry Global, Inc. ZH05SQ; Berry Global, Inc.ZH50SQM Localized push in while turning, force must be applied to designated place onclosureBway Corporation Screw TopN Localized push back lever while turning, force must be applied to designatedplace on closureNone at t

31、his timeO Turn the top cap until stops, then push down and turn M Pac-Tec Inc.-Palm-N-Turn; Berry Global, Inc. Screw Loc; KerrCR-V; Berry Global, Inc. Friendly and Safe; Thornton Plastics Tot-Lok; ChildRelated Research, Inc. Push-Palm; Design Consultant Plastics; InventivePackaging Corp., Clarke Con

32、tainer Push Cebal Americas (tube) Berry Global, Inc. Purse Pak; BerryGlobal, Inc., Spring-Loc; Berry Global, Inc. PursePak; Berry Global, Inc.Tube-LocB Hold fitment down while turning closure Berry Global, Inc. Snap-Lok, Econo-Lok; Berry Global, Inc.-1-Clic;CannaContainers, CR VialC Unlock outer rin

33、g to release lugs Thornton 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 time

34、TYPE III RECLOSABLE PACKAGINGSNAP CLOSURED3475 182TABLE 1 ContinuedDescription ExampleA(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; Central States Can Co.;Boyle Midway; Clarke Container Snap Lok; VH Techno

35、logies-virtual hingeLutaloc LLC, Lutaloc; CannaContainers, CR J-Tube(2) Rotate then lift Continental 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. Pro

36、ductsD(1) Press to release and then lift hinged tab (dispensing cap) Magenta Corp.; Lumlite PopLok; MeadWestvaco (MWV): Slatersville, LLC; PS194 Toggloc, PS 211 Toggloc, PS 355 Toggloc.(2) Press to release, follow by lifting force on tab (removable cap) Wheaton Industries Ryles Closure; Magenta Corp

37、. 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 lid (dispensing cap) Stull Technologies: StullSURE(6) Push in and flip up CSP Technologies

38、, ACTIV-VIAL; Ropak Packaging EZ STOR (UC2G)(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; Berry Global, Inc. Flip-Lok; Berry Global, Inc. SeriesCR FlipLok(2) Squeeze and lift one specific point si

39、multaneously(3) Squeeze two points simultaneously to open Berry Global, Inc.; FTCR 19000, FTCR 19100, FTCR 19500; Philips RxPackaging LLC, Rx Squeeze Vial; LA Packaging, SqueezeTops PharmacyVialF Squeeze two specific points simultaneously to unlock sides, then squeezespecific point on third side whi

40、le 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; Berry Global, Inc. SnapCap;Pin Lock, Inc. Pin Lock; K

41、err Glass Pry Off; Genpak Corp. Pry Off;Cin-Made Corporation (container) CMI (closure) Tec Loc; Continental FibreDrum Leverpak; Berry Global, Inc.; Plastican, Inc. Lever/Toggle Band on Pail;Container Products Inc. Lever Lok; Cin Made Corp. Friction Fit Plug; SilganPlastics Corporation 28MM-410 CR Di

42、spensing Nozzle Closure; Berry Global,Inc. T02CR, L02S, T16CR(B) and L16CR, MeadWestvaco (MWV):Slatersville, LLC: PS 186 Loctop.H 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

43、push up tab or lip Robert Linkletter AssociatesK Rotate cap to a first index, then counterrotate cap to a second index, thenlift capYellowstone Environmental Science, Inc. WiseCapTYPE IV UNIT NON-RECLOSABLE PACKAGINGFLEXIBLE (STRIP/POUCH)A Internal (hidden) tear notch Sharp; Reynolds Aluminum (Safet

44、y Pak 101); PCM Corp.; Cardinal Health;West Pharma-Services; Reed-Lane, Inc.B Oriented tear Schering Corp.; Sharp; 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.

45、; Pactech Packaging LLC; CannalineTYPE V UNIT NON-RECLOSABLE PACKAGINGRIGIDA Requires tool All metal canB Requires localized force None 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

46、allow use of product without human contact;and (2) Two piece plastic unit with multiple holes to allow use of productwithout human contactD Push down while turning closure is not removed; contents are exposedthrough hole in closure tip.Neopac Twist n Use (on tube)TYPE VI UNIT RECLOSABLE PACKAGEA Met

47、ered device None at this timeTYPE VII AEROSOL PACKAGESA Localized squeeze while lifting removes overcap (actuates normally) Knight Engineering; Berry Global, Inc.; Cobra Plastics Inc. 65 mm NICR; BerryGlobal, Inc. 202SP Berry Global, Inc. 211NSR; Berry Global, Inc.211SRCB Hold fitment still while tu

48、rning (actuates normally) Thomas ClosureC Hold 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

49、-actuator requires sequential simultaneous pushing oflocking device and actuatorUnion Carbide; Seaquist; Berry Global, Inc. 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 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 isnecessa