1、Designation: D3475 16D3475 17Standard 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 paren
2、theses indicates 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-resistant packages.1.2 The examples for each type of child-resistant packaging are not intended to b
3、e all-inclusive, but are included only as an aidin the understanding and comprehension of each type of classification.1.3 Listings are not to be considered endorsements or approval of the package by ASTM.1.4 This international standard was developed in accordance with internationally recognized prin
4、ciples on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 child
5、-resistant packageas defined by the Poison Prevention Packaging Act, packaging that is designed or constructedto be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substancecontained therein within a reasonable time, and not difficult f
6、or normal adults to use properly, but does not mean packaging whichall such children cannot open or obtain a toxic 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 each individualproduct package is in
7、tended to be opened or used one time in a generally non-reclosable or non-resealable manner, separately fromthe other individual product units in the package, or the entire contents of a single unit package intended for use in one application.2.1.2.1 DiscussionNormally used for pharmaceutical, human
8、 healthcare, and nutritional products in dry solid, topical, transdermal, or liquid form.A unit of sale package may contain one or more individual unit dose packages, that is, individually wrapped transdermal patches,pre-filled syringes and syringe cartridges, blister cards with multiple tablets or
9、capsules, and so forth. Unit dose packages may ormay not be child-resistant in accordance with the regulatory requirements of the package contents.2.1.3 unit use/single use packagean immediate product container/package, which may include label directions for use,designed in such a manner that each i
10、ndividual product package is intended to be opened or used one time separately from the otherindividual product units in the package, or the entire contents of a single unit package intended for use in one application.2.1.3.1 DiscussionThese packages are generally non-reclosable or non-reusable. A u
11、nit of sale package may consist of one or more non-reusableindividual packages. Generally used for household, automotive, chemical, pesticide, veterinary, garden and other products notintended for human ingestion. Package styles may include some aerosol, that is, foggers, soluble film, canisters, po
12、uches, and soforth, filled with liquids, dries, powders, and other product forms. Packages may or may not be child-resistant in accordance withthe regulatory requirements of the package contents.1 This classification is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packagin
13、g and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved April 1, 2016March 1, 2017. Published May 2016April 2017. Originally approved in 1976. Last previous edition approved in 20152016 asD3475 15.D3475 16. DOI: 10.1520/D3475-16.10.1520/D34
14、75-17.2 Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. Available from U.S. Government Printing Office Superintendent of Documents, 732 N. CapitolSt., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.This document is not an ASTM standard and is intended onl
15、y to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versi
16、onof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Significance and Use3.1 This classification scheme defines the type of motions, skills, or tools requi
17、red for a particular type of child-resistant packageand provides examples of current packaging within that type.3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval ofthe package by ASTM.3.3 Packages have been included as exampl
18、es based on manufacturers claims of child-resistance. Child-resistant packagefunctionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPAof 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The
19、listing of a package in thisclassification is not an indication of whether or not it has been successfully tested in accordance with the aforementionedguidelines.3.4 Additions or deletions to the examples should be reported to Committee D10 on Packaging, for incorporation into thisclassification dur
20、ing the next revision.4. Basis of Classification4.1 The functional basis for classification and the classifications appear in Table 1.TABLE 1 Classification of Child-Resistant PackagesDescription ExampleTYPE I RECLOSABLE PACKAGINGCONTINUOUS THREAD CLOSUREA Random push down while turning; no orientat
21、ion of the push down forcenecessaryKerr CR-I, II, III, IV and CRTE; Rexam Healthcare 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; Rexam Healthcare F.G.
22、 (Final Generation), Carow-Turnloc;Comar-Secure Cap; Reike-FS652; CCL 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
23、Pictorial Screw Cap, PDT Push Down Drug Plastics GerresheimerBoleslawiec S.A. NG 38C; Berry Plastics Corporation CR-I/TEIII; BerryPlastics Corporation CR-III; Berry Plastics Corporation CR3A/LR; BerryPlastics Corporation CR5; Berry Plastics Corporation CR4; Berry PlasticsCorporation MAC DumaA Random
24、 push down while turning; no orientation of the push down forcenecessaryKerr CR-I, II, III, IV and CRTE; Berry Plastics Corp. 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.
25、;Reliable Products; Berry Plastics Corp. F.G. (Final Generation), Carow-Turnloc; Comar-Secure Cap; Reike-FS652; CCL Container Corporaton (tube)Van Blarcom Closures Inc.Dropper Closure, Saf-Cap Convertible, 1-1/8 Beta Closure; Bericap NorthAmerica, Bericap SK28/26 CR Slitband; Sanner of America, Chil
26、d ResistantScrew Cap; Mold-rite Plastics CRC Pictorial Screw Cap, PDT Push Down Drug Plastics GerresheimerBoleslawiec S.A. NG 38C; Berry Plastics Corporation CR-I/TEIII; BerryPlastics Corporation CR-III; Berry Plastics Corporation CR3A/LR; BerryPlastics Corporation CR5; Berry Plastics Corporation CR
27、4; Berry PlasticsCorporation MAC DumaB Localized squeeze force while turning; the force must be applied to adesignated location on the closure skirtEcono-Lok, DOT, Dougherty Brothers; Fastex; Rexam Healthcare Squeeze andTurn; Berry Plastics-Squeeze Weatherchem-TopSqueeze; Kerr-Tab II Squeeze Rieke F
28、S633, HZ43CR, HZ24CR; USCan-Screw top; Squeeze Lok Low Profile, FG; Rieke Corporation StolzHZ32CR; Val-Pak Products, 63-400 Squeeze Cap; Berry Plastics CorporationDOT Series DCR; Berry Plastics Corporation DOT Series DCR-TI; BerryPlastics Corporation Drain Back System; Berry Plastics Corporation Jig
29、ger;Berry Plastics Corporation Quarter-Turn; Berry Plastics Corporation Snap-LokII; Berry Plastics Corporation Squeeze and Turn; Berry Plastics CorporationSQL; Berry Plastics Corporation Tab II; Pollen, Double SqueezeB Localized squeeze force while turning; the force must be applied to adesignated l
30、ocation on the closure skirtEcono-Lok, DOT, Dougherty Brothers; Fastex; Berry Plastics Corp. Squeezeand Turn; Berry Plastics-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,
31、 63-400 Squeeze Cap; Berry Plastics CorporationDOT Series DCR; Berry Plastics Corporation DOT Series DCR-TI; BerryPlastics Corporation Drain Back System; Berry Plastics Corporation Jigger;Berry Plastics Corporation Quarter-Turn; Berry Plastics Corporation Snap-LokII; Berry Plastics Corporation Squee
32、ze and Turn; Berry Plastics CorporationSQL; Berry Plastics Corporation Tab II; Pollen, Double SqueezeC Random squeeze while turning; no orientation of the squeeze force isnecessaryD3475 172TABLE 1 ContinuedDescription ExampleD Holding a fitment while turning; two-handed operation is normally require
33、d Thomas Closure Moldcraft; M Berry PlasticsCorporation 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 skirt or tab on closure while turning Char
34、les 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; Rexam HealthcareH Localized push down while turning; force must be applied to a designatedplace on the top of the
35、closureMack Wayne Plastics; Anchor Hocking Mold Craft; Berry Plastics Corp.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 Plastics
36、 Corp.-pail; Berry Plastics Corporation ZH05SQ; Berry PlasticsCorporation T05SCR(B) Berry Plastics Corporation ZH05SQ;Berry Plastics Corporation ZH50SQM Localized push in while turning, force must be applied to designated place onclosureBway Corporation Screw TopN Localized push back lever while tur
37、ning, 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 Healthcare Screw Loc; KerrCR-V; Berry Plastics Corporation Friendly and Safe; Thornton Plastics Tot-Lok; Child Related Research, Inc. Pu
38、sh-Palm; Design Consultant Plastics;Inventive Packaging Corp., Clarke Container Push Cebal Americas(tube) Rexam Healthcare PursePak; Rexam Healthcare, Spring-Loc; Rexam Healthcare PursePak; RexamHealthcare Tube-LocA Random push down while turning Eyelet Specialty; Pac-Tec Inc.-Palm-N-Turn; Berry Pla
39、stics Corp. Screw Loc;Kerr CR-V; Berry Plastics Corporation Friendly and Safe; Thornton PlasticsTot-Lok; Child Related Research, Inc. Push-Palm; Design ConsultantPlastics; Inventive Packaging Corp., Clarke Container Push CebalAmericas (tube) Berry PlasticsCorp. Purse Pak; Berry Plastics Corp., Sprin
40、g-Loc; Berry Plastics Corp.PursePak; Berry Plastics Corp. Tube-LocB Hold fitment down while turning closure Rexam Healthcare Snap-Lok, Econo-Lok; Rexam Healthcare-1-Clic;CannaContainers, CR VialB Hold fitment down while turning closure Berry Plastics Corp. Snap-Lok, Econo-Lok; Berry Plastics Corp.-1
41、-Clic;CannaContainers, CR VialC Unlock outer ring 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 orientatio
42、n of holding force is specifiedNone at this timeTYPE III RECLOSABLE 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; Central States Can Co.;Boyle Midway; Clarke Container Snap Lok; VH Te
43、chnologies-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.
44、 ProductsD (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
45、 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 lid (dispensing cap) Stull Technologies: StullSURE(6) Push in and flip up CSP Technol
46、ogies, 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; Rexam Healthcare Flip-Lok; Berry PlasticsCorporation Series CR FlipLokE (1) Squeeze and lift two spe
47、cific points simultaneously Pennwalt-Lye; J. L. Clark; Berry Plastics Corp. Flip-Lok; Berry PlasticsCorporation Series CR FlipLok(2) Squeeze and lift one specific point simultaneously(3) Squeeze two points simultaneously to open Berry Plastics Corp.; FTCR 19000, FTCR 19100, FTCR 19500; Philips RxPac
48、kaging LLC, Rx Squeeze Vial; LA Packaging, SqueezeTops PharmacyVialF Squeeze two specific points simultaneously to unlock sides, then squeezespecific point on third side while lifting lidShaw-Clayton Press N Pop; Norman J. LarusD3475 173TABLE 1 ContinuedDescription ExampleG Requires key device or fi
49、ngernail 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 Healthcare SnapCap;Pin Lock, Inc. Pin Lock; Kerr 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 Dispensing Nozzle Closure; ; BerryPlastics Corp. T02CR, L02S, T16
