ASTM D3475-11
(Classification)Standard Classification of Child-Resistant Packages
Standard Classification of Child-Resistant Packages
SIGNIFICANCE AND USE
This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.
Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.
Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157. The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.
Additions or deletions to the examples should be reported to Committee D10 on Packaging, for incorporation into this classification during the next revision.
SCOPE
1.1 This classification covers various types of child-resistant packages.
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in 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.
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Designation: D3475 – 11
Standard Classification of
1
Child-Resistant Packages
This standard is issued under the fixed designation D3475; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope wrapped transdermal patches, pre-filled syringes and syringe
cartridges, blister cards with multiple tablets or capsules, and
1.1 Thisclassificationcoversvarioustypesofchild-resistant
so forth. Unit dose packages may or may not be child-resistant
packages.
in accordance with the regulatory requirements of the package
1.2 The examples for each type of child-resistant packaging
contents.
are not intended to be all-inclusive, but are included only as an
2.1.3 unit use/single use package—an immediate product
aid in the understanding and comprehension of each type of
container/package, which may include label directions for use,
classification.
designed in such a manner that each individual product
1.3 Listings are not to be considered endorsements or
package is intended to be opened or used one time separately
approval of the package by ASTM.
from the other individual product units in the package, or the
2. Terminology
entire contents of a single unit package intended for use in one
application.
2.1 Definitions of Terms Specific to This Standard:
2.1.3.1 Discussion—These packages are generally non-
2.1.1 child-resistant package—as defined by the Poison
reclosable or non-reusable. A unit of sale package may consist
Prevention Packaging Act, packaging that is designed or
of one or more non-reusable individual packages. Generally
constructed to be significantly difficult for children under five
used for household, automotive, chemical, pesticide, veteri-
years of age to open or obtain a toxic or harmful amount of the
nary, garden and other products not intended for human
substance contained therein within a reasonable time, and not
ingestion. Package styles may include some aerosol, that is,
difficult for normal adults to use properly, but does not mean
foggers, soluble film, canisters, pouches, and so forth, filled
packaging which all such children cannot open or obtain a
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with liquids, drys, powders, and other product forms. Packages
toxic or harmful amount within a reasonable time.
may or may not be child-resistant in accordance with the
2.1.2 unit dose package—an immediate product container/
regulatory requirements of the package contents.
package designed and labeled in such a manner that each
individual product package is intended to be opened or used
3. Significance and Use
one time in a generally non-reclosable or non-resealable
3.1 This classification scheme defines the type of motions,
manner, separately from the other individual product units in
skills, or tools required for a particular type of child-resistant
the package, or the entire contents of a single unit package
package and provides examples of current packaging within
intended for use in one application.
that type.
2.1.2.1 Discussion—Normally used for pharmaceutical, hu-
3.2 Reference to a particular package in this classification is
man healthcare, and nutritional products in dry solid, topical,
not intended in any manner to denote endorsement or approval
transdermal, or liquid form.Aunit of sale package may contain
of the package by ASTM.
one or more individual unit dose packages, that is, individually
3.3 Packages have been included as examples based on
manufacturers’ claims of child-resistance. Child-resistant
1
This classification is under the jurisdiction of ASTM Committee D10 on
package functionality for any specific product type must be
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,
determined by the packager/manufacturer following the guide-
Pharmaceutical and Medical Packaging.
lines of the PPPA of 1970 and the most current version of the
Current edition approved April 1, 2011. Published May 2011. Originally
2
approved in 1976. Last previous edition approved in 2009 as D3475 – 09. DOI:
CFR Title 16 Part 1700 and Title 40 Part 157. The listing of
10.1520/D3475-11.
a package in this classification is not an indication of whether
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.
or not it has been successfully tested in accordance with the
Available from U.S. Government Printing Office Superintendent of Documents, 732
aforementioned guidelines.
N. 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 States.
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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 the previous version. Because
it 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 version
of the standard as published by ASTM is to be considered the official document.
Designation:D3475–09 Designation: D3475 – 11
Standard Classification of
1
Child-Resistant Packages
This standard is issued under the fixed designation D3475; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This classification covers various types of child-resistant packages.
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid
in 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. Terminology
2.1 Definitions of Terms Specific to This Standard:
2.1.1 child-resistant package—as defined by the Poison Prevention Packaging Act, packaging that is designed or constructed
to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance
contained therein within a reasonable time, and not difficult for normal adults to use properly, but does not mean packaging which
2
all such children cannot open or obtain a toxic or harmful amount within a reasonable time.
2.1.2 unit dose package—an immediate product container/package designed and labeled in such a manner that each individual
product package is intended to be opened or used one time in a generally non-reclosable or non-resealable manner, separately from
the 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 Discussion—Normally used for pharmaceutical, human healthcare, 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, individually
wrappedtransdermalpatches,pre-filledsyringesandsyringecartridges,blistercardswithmultipletabletsorcapsules,andsoforth.
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 package—an immediate product container/package, which may include label directions for use,
designedinsuchamannerthateachindividualproductpackageisintendedtobeopenedorusedonetimeseparatelyfromtheother
individual product units in the package, or the entire contents of a single unit package intended for use in one application.
2.1.3.1 Discussion—These packages are generally non-reclosable or non-reusable. A unit of sale package may consist of one
or more non-reusable individual packages. Generally used for household, automotive, chemical, pesticide, veterinary, garden and
other products not intended for human ingestion. Package styles may include some aerosol, that is, foggers, soluble film, canisters,
pouches, and so forth, filled with liquids, drys, powders, and other product forms. Packages may or may not be child-resistant in
accordance with the regulatory requirements of the package contents.
3. Significance and Use
3.1 Thisclassificationschemedefinesthetypeofmotions,skills,ortoolsrequiredforaparticulartypeofchild-resistantpackage
and 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 of
the package by ASTM.
3.3 Packages have been included as examples based on manufacturers’ claims of child-resistance. Child-resistant package
functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA
2
of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157. The listing of a package in this
classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned
guidelines.
3.4 Additions or deletions to the examples should be reported to Committee D10 on Packaging, for incorporation into this
classification during the next revision.
1
ThisclassificationisunderthejurisdictionofASTMCommitteeD10onPackagingandisthedirectresponsibilityofSubcommitteeD10.32onConsumer,Pharmaceutical
and Medical Packaging.
Current edition approved MarchApril 1, 2009.2011. Published March 2009.May 2011. Originally approved in 1976. Last previous edition approved in 20082009 as
D3475 – 089. DOI: 10.1520/D3475-09.10.152
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