1、Designation:D347511 Designation: D3475 12Standard 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 num
2、ber in parentheses 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 i
3、ntended to be 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.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 child-resista
4、nt 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 for norma
5、l 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 intended t
6、o 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 healthc
7、are, 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, individuallywrapped transdermal patches, pre-filled syringes and syringe cartridges, blister cards with multiple tablets or capsules
8、, and so forth.Unit dose packages may or may 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 individua
9、l 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 unit of s
10、ale package may consist of oneor more non-reusable individual packages. Generally used for household, automotive, chemical, pesticide, veterinary, garden andother products not intended for human ingestion. Package styles may include some aerosol, that is, foggers, soluble film, canisters,pouches, an
11、d so forth, filled with liquids, drys, powders, and other product forms. Packages may or may not be child-resistant inaccordance with the regulatory requirements of the package contents.3. Significance and Use3.1 This classification scheme defines the type of motions, skills, or tools required for a
12、 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 examples based
13、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 157.2The listing of
14、 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 during the ne
15、xt revision.1This classification is under the jurisdiction of ASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical, Medical, and Medical Child Resistant Packaging.Current edition approved April 1, 2011.2012. Published May 2011.2012. Origi
16、nally approved in 1976. Last previous edition approved in 20092011 asD347509.D3475 11. DOI: 10.1520/D3475-112.2Code 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, W
17、ashington, DC 20401, http:/www.access.gpo.gov.1This document is not an ASTM standard and is intended only 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 accuratel
18、y, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof 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 States.4
19、. 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 PACKAGINGCONTINUOUS THREAD CLOSUREA Random push down while turning; no o
20、rientation 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.; Reliable Products; Rexam F.G.(Final Generation), Carow-Turnlo
21、c; 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 Screw Cap; Mold-rite Plastics CRC Pictorial ScrewCap, PDT Push Dow
22、n 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 Squeeze Rieke FS633, HZ43CR, HZ24CR; US Can-Screw top; Rexam Inc. Dra
23、in 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 while turning; two-handed operation is normally required Thomas Clo
24、sure 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 skirt or tab on closure while turning Charles A. Breskin; Alcoa T
25、ot 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 turn Intermova Gate Lok, Lefty LokK Align arrows, then push tab do
26、wn, 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 Company-pailN Localized push back lever while turning, force must b
27、e 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; Design Consultant Plastics; Inventive Packaging Corp., ClarkeContai
28、ner 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 one side Plastic box with sliding lug lock (manufacturer unknown)
29、; 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 push up on tab or lip Bristol-Myers; Calmar Snap Safe; Stull; P
30、lastic 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 downward pressure to open Polymold; Basic Products Poly MoldC Downwa
31、rd 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, follow by lifting force on tab (removable cap) Wheaton Industries Ry
32、les 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 lid (dispensing cap) Stull Technologies: StullSURE(6) Push in and
33、 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-Lok(2) Squeeze and lift one specific point simultaneously(3) Squeeze two points simultaneously to open
34、 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; Norman J. LarusD3475 122TABLE 1 ContinuedDescription Examp
35、leG 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 Corporation (con
36、tainer) 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 ClosureH Lift locking tab then push up Internova Corp
37、. 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, thenlift capYellowstone Environmental Science, Inc. Wi
38、seCapTYPE 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; American National Can Co.; Reed-Lane, Inc.C Requires tool H
39、argo 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 timeC Peelable backing or coating Standard packagingPac
40、kage 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 contactTYPE VI UNIT RECLOSABLE PACKAGEA Metered device None at this
41、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 fitment still while lifting (actuates normally) None at thi
42、s 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 pushing oflocking device and actuatorUnion Carbide; Seaquist; R
43、exam 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
44、 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.L Localized push up to remove Berry Plastics Corp.M Line-up
45、 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-RECLOSABLE PACKAGINGSEMI-RIGID (BLISTER)A Remove a portion(1)
46、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 portion (tab), rotate the blister to orient, push through Co
47、lbert, 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; Constantia Hueck Folien(2) Peel back and push out Sharp; Proc
48、linical, 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 Ivers-LeeD3475 123TABLE 1 ContinuedDescription ExampleE Pus
49、h 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 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
