1、Designation: D3475 12D3475 13Standard 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, drys,dries, powders, and other product forms. Packages may or may not be child-resistant in accordancewith 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 parti
12、cular 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 Packagi
13、ng.Current edition approved April 1, 2012April 1, 2013. Published May 2012September 2013. Originally approved in 1976. Last previous edition approved in 20112012 asD3475 11.D3475 12. DOI: 10.1520/D3475-12.10.1520/D3475-13.2 Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. Ava
14、ilable 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 ma
15、de 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 versionof the standard as published by ASTM is to be considered the official document.Cop
16、yright 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 example
17、s 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 l
18、isting 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 duri
19、ng the 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 do
20、wn while turning; no orientation 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 Gen
21、eration), Carow-Turnloc; 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
22、ScrewCap, PDT Push Down 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.;Relia
23、ble 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 of America, Child Resistan
24、t 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 Corporation CR4; Berry P
25、lasticsCorporation MAC DumaB Localized squeeze force while turning; 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 Squ
26、eeze Rieke FS633, HZ43CR, HZ24CR; US Can-Screw top; Rexam Inc. Drain BackSystem; Rexam Jigger, Snap-Lok II, Squeeze Lok Low Profile; RiekeCorporation Stolz HZ32CR; Val-Pak Products, 63-400 Squeeze CapB Localized squeeze force while turning; the force must be applied to adesignated location on the cl
27、osure skirtEcono-Lok, DOT, DoughertyBrothers; Fastex; Rexam Healthcare Squeeze and Turn; Berry Plastics-Squeeze Weatherchem-Top Squeeze; Kerr-Tab IISqueeze Rieke FS633, HZ43CR, HZ24CR; US Can-Screw top;Squeeze Lok Low Profile, FG; Rieke Corporation Stolz HZ32CR; Val-PakProducts, 63-400 Squeeze Cap;
28、Berry Plastics Corporation DOT Series DCR;Berry Plastics Corporation DOT Series DCR-TI; Berry Plastics CorporationDrain Back System; Berry Plastics Corporation Jigger; Berry PlasticsCorporation Quarter-Turn; Berry Plastics Corporation Snap-Lok II; BerryPlastics Corporation Squeeze and Turn; Berry Pl
29、astics Corporation SQL;Berry Plastics Corporation Tab IIC Random 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 Plastics,Lite-TouchD Holding a fitment while turning;
30、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 lift force is necessaryG Localized lift of cap sk
31、irt 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 combination before turning None at this timeJ Pull t
32、ab 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 ZH05SQD3475 132TABLE 1 ContinuedDescription ExampleL Turn closure until stops, then lift and
33、continue trying to open Berry Plastics 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 onclosureU S Can Company-pailM Loc
34、alized 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.-Palm-N-Turn
35、; Rexam Screw Loc; Kerr CR-V Thornton Plastics Tot-Lok; Child Related Research, Inc.Push-Palm; Design Consultant Plastics; Inventive Packaging Corp., ClarkeContainer Push Cebal Americas (tube) Rexam Inc. Purse Pak; Rexam, Spring-LocA Random push down while turning Eyelet Specialty; Pac-Tec Inc.-Palm
36、-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 Healthcare
37、, Spring-Loc; Rexam Healthcare PursePak; RexamHealthcare Tube-LocB Hold fitment down while turning closure Rexam Snap-Lok, Econo-Lok; Rexam-1-ClikB Hold fitment down while turning closure Rexam Healthcare Snap-Lok, Econo-Lok; Rexam Healthcare-1-ClicC Unlock outer ring to release lugs Thornton Plasti
38、csD 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 PACKAGINGSNAP
39、 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 hinge(2) Rotate then lift Continental Carlisle Co. Unikon; Mag
40、enta 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) Magenta Corp.; Lumlite PopLok; Polytop ToggLoc Dispensi
41、ng ClosureD (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; Magent
42、a 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 Techno
43、logies, ACTIV-VIAL(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 simultaneously Pennwalt-Lye; J. L. Clark; Rexam Flip-LokE (1) Squeeze and lift two specif
44、ic 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) Squeeze two points simultaneously to open MAC Closures Inc.; FTCR 19000, FTCR 19100, FTCR 19500; Philips RxPackaging LLC
45、, Rx Squeeze Vial(3) Squeeze two points simultaneously to open Berry Plastics Corp.; 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
46、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 Snap Cap;Pin Lock, Inc. Pin Lock; Kerr Glass Pry Off; Genpak Corp. Pry Off;Cin-M
47、ade 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 ClosureG Requires key device or f
48、ingernail 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 (closu
49、re) 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, 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 OffD3475 133TABLE 1 ContinuedDescription ExampleJ Align two points, push down outer ring, then push up tab o
