1、Designation: D3475 16Standard 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. 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 forth. Unit dose package
8、s 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,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, filledwith liquids, dries, p
11、owders, 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.
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 in
14、dication 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.1This classification is under the
15、 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 April 1, 2016. Published May 2016. Originallyapproved in 1976. Last previous edition approved in 2015 as
16、 D3475 15. DOI:10.1520/D3475-16.2Code 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, http:/www.access.gpo.gov.Copyright ASTM International, 100
17、 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. Basis of Classification4.1 The functional basis for classification and the classifi-cations appear in Table 1.TABLE 1 Classification of Child-Resistant PackagesDescription ExampleTYPE I RECLOSABLE PACKAGINGCONTINUOUS
18、 THREAD CLOSUREA Random push down while turning; no orientation 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 Gutm
19、an; Poly Seal Corp.;Reliable Products; Rexam Healthcare F.G. (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 o
20、f America, Child Resistant ScrewCap; 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
21、 Corporation CR4; 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
22、Squeeze Rieke FS633, 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
23、Corporation Jigger;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 SqueezeC Random squeeze while turning; no orientation of the squeeze force
24、isnecessaryD Holding a fitment while turning; two-handed operation is normally required 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 lif
25、t 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; Anchor Hocking Mold Craft; Rexam HealthcareI Set combin
26、ation 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 Corp.-pail; Berry Plastics Corporation ZH05SQ; Berry PlasticsCorporation T05SCR(B) Ber
27、ry 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 turning, force must be applied to designatedplace on closureNone at this timeO Turn the to
28、p 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. Push-Palm; Design Consultant Plastics;Inventive Packaging Corp., Clarke Container Push Ce
29、bal Americas(tube) Rexam Healthcare PursePak; Rexam Healthcare, Spring-Loc; Rexam Healthcare PursePak; RexamHealthcare Tube-LocB Hold fitment down while turning closure Rexam Healthcare Snap-Lok, Econo-Lok; Rexam Healthcare-1-Clic;CannaContainers, CR VialC Unlock outer ring to release lugs Thornton
30、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 PACKAGI
31、NGSNAP 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 Technologies-virtual hingeLutaloc LLC, Lutaloc; CannaContainers, CR J-Tube(2)
32、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. ProductsD(1) Press to release and then lift hinged tab (dispensing cap) Mag
33、enta Corp.; Lumlite PopLok; MeadWestvaco (MWV): Slatersville, LLC; PS194 Toggloc, PS 211 Toggloc, PS 355 Toggloc.D3475 162TABLE 1 ContinuedDescription Example(2) Press to release, follow by lifting force on tab (removable cap) Wheaton Industries Ryles Closure; Magenta Corp. Pop-Lok Plug(3) Push up t
34、o 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, ACTIV-VIAL; Ropak Packagi
35、ng 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 FlipLok(2) Squeeze and lift one specific point simultaneously(3) Squee
36、ze two points simultaneously to open Berry Plastics Corp.; 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 while lifting lidShaw-
37、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 Healthcare SnapCap;Pin Lock, Inc. Pin Lock; Kerr Glass Pry Off; Ge
38、npak 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;
39、; BerryPlastics Corp. 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 push up tab or lip Ro
40、bert 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 (Safety Pak 101); PCM Corp.
41、; 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.; Pactech Packaging L
42、LCTYPE 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 allow use of product without hum
43、an 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 Metered device None at this timeTYP
44、E VII AEROSOL PACKAGESA Localized squeeze while lifting removes overcap (actuates normally) Knight Engineering; Berry Plastics; Cobra Plastics Inc. 65 mm NICR; BerryPlastics Corporation 202SP Berry Plastics Corporation 211NSR;Berry Plastics Corporation 211SRCB Hold fitment still while turning (actua
45、tes 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-actuator re
46、quires sequential simultaneous pushing oflocking device and actuatorUnion Carbide; Seaquist; Rexam Healthcare 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 upwardf
47、orce 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 isnecessaryITL (Hayes-Albion)K Localized press d
48、own then pull up at arrow Berry Plastics Corporation 211RCRL Localized push up to remove Berry Plastics Corporation 211DCP; Berry Plastics Corporation 300RCRM Line-up arrows on the overcap and ring to remove Magenta Corporation (design by Innopak) Airsafe; Pierson Industries Inc.(Contact Technimark
49、Associates) Hold Collar Line up Arrows Safety Closure,Universally Adaptable Safety ClosureTYPE VIII NON-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 SharpD3475 163TABLE 1 ContinuedDescription Example(3) Remove portion (tab) and push out MeadWestvaco (MWV): Healthcare Packaging PerfPak; Howell Packaging,Howel-CR-III;(4) Remove portion (tab), rotate the blister to orient, push through Colbert, PharmaDial(5) Push to expos
