ASTM_D_3475_-_15.pdf

Designation:D347515Standard 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 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-resistantpackages.1.2 The examples for each type of child-resistant packagingare not intended to be all-inclusive,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 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,but 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 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 in dry solid,topical,transdermal,or liquid form.Aunit 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 packages 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 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 non-reusable individual packages.Generallyusedforhousehold,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,powders,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 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.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 indication 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 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 1,2015.Published May 2015.Originallyapproved in 1976.Last previous edition approved in 2014 as D3475 14.DOI:10.1520/D3475-15.2Code 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 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Basis of Classification4.1 The functional basis for classification and the classifi-cations appear in Table 1.TABLE 1 Classification of Child-Resistant PackagesDescriptionExampleTYPE I RECLOSABL