1、Designation: D3475 13D3475 14Standard 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.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 child-resistant packageas
4、 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 normal adults to
5、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 to be opened
6、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 healthcare, and nut
7、ritional 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 capsules, and so for
8、th. 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 individual product pa
9、ckage 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 sale package
10、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, pouches, and soforth,
11、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.3. Significance and Use3.1 This classification scheme defines the type of motions, skills, or tools required for a particular
12、 type of child-resistant packageand provides examples of current packaging within that type.1 This 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 Child Resistant Packaging.Cu
13、rrent edition approved April 1, 2013April 1, 2014. Published September 2013May 2014. Originally approved in 1976. Last previous edition approved in 20122013 asD3475 12.D3475 13. DOI: 10.1520/D3475-13.10.1520/D3475-14.2 Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. Availabl
14、e 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 only to provide the user of an ASTM standard an indication of what changes have been made to
15、 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 versionof the standard as published by ASTM is to be considered the official document.Copyrigh
16、t ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.2 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 bas
17、ed 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 listin
18、g 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 during th
19、e 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 PACKAGINGCONTINUOUS THREAD CLOSUREA Random push down wh
20、ile 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 Gutman; Poly Seal Corp.;Reliable Product
21、s; 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 of America, Child Resistant ScrewCap;
22、 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 CR4; Berry PlasticsCorp
23、oration 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 FS633, HZ43CR, HZ24CR;
24、 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 Jigger;Berry Plastics Co
25、rporation Quarter-Turn; Berry Plastics Corporation Snap-LokII; Berry Plastics Corporation Squeeze and Turn; Berry Plastics CorporationSQL; Berry Plastics Corporation Tab IIC Random squeeze while turning; no orientation of the squeeze force isnecessaryD Holding a fitment while turning; two-handed ope
26、ration 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 lift force is necessaryG Localized lift of cap skirt or tab on
27、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 combination before turning None at this timeJ Pull tab then turn I
28、ntermova 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) Berry Plastics Corporation ZH05SQ;Berry Plastics Corporation ZH
29、50SQM 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 top cap until stops, then push down and turn M Pac-Tec Inc.-Pa
30、lm-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 Cebal Americas(tube) Rexam Healthcare PursePak; Rexam Healthca
31、re, Spring-Loc; Rexam Healthcare PursePak; RexamHealthcare Tube-LocB Hold fitment down while turning closure Rexam Healthcare Snap-Lok, Econo-Lok; Rexam Healthcare-1-ClicC Unlock outer ring to release lugs Thornton PlasticsD Depress fitment and slide to one side Plastic box with sliding lug lock (ma
32、nufacturer unknown); Creative PackagingLok-PakD3475 142TABLE 1 ContinuedDescription ExampleE 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 the
33、n 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 dow
34、nward 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; MeadWestvaco (MWV): Slatersville, LLC; PS194 Toggloc, PS 2
35、11 Toggloc, PS 355 Toggloc.(2) Press to release, follow 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
36、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 Packaging EZ STOR (UC2G)(7) Push in and up then flip up CSP Technologies, Mini Cooper VialE (1) Squeeze and lift two specific points simul
37、taneously Pennwalt-Lye; J. L. Clark; Rexam Healthcare 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 RxPackaging LLC, Rx Squeeze
38、 VialF Squeeze two specific points simultaneously to unlock sides, then squeezespecific point on third 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. P
39、rex 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;Conta
40、iner Products Inc. Lever Lok; Cin Made Corp. Friction Fit Plug; SilganPlastics Corporation 28MM-410 CR Dispensing Nozzle Closure; ; 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 Rando
41、m 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. WiseCapTYPE IV UNIT
42、 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 Hargo Flexible Pac
43、kaging (Pos-I-Pak); Sharp; Hach Chemical Co.;American National Can Co.; Cardinal Health;Paco; Reed-Lane, Inc.; Pactech Packaging LLCTYPE V UNIT NON-RECLOSABLE PACKAGINGRIGIDA Requires tool All metal canB Requires localized force None at this timeC Peelable backing or coating Standard packagingPackag
44、e 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 contactD Push down while turning closure is not removed; contents are e
45、xposedthrough hole in closure tip.Neopac Twist n Use (on tube)TYPE 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 NICR; BerryPlast
46、ics Corporation 202SP Berry Plastics Corporation 211NSR;Berry Plastics Corporation 211SRCB Hold fitment still while turning (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 G
47、reen, 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; Rexam Healthcare CR AerosolG Directional overcap-actuator which requires a fi
48、nger 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 a
49、t this timeJ Random push down while turning; no orientation of the downward force isnecessaryITL (Hayes-Albion)D3475 143TABLE 1 ContinuedDescription ExampleK Localized press down 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 Associates) Hold Collar Line up Arrows Safety Closure,Universally Adaptable Safety ClosureTYPE
