ASTM D3475-08
(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: D 3475 – 08
Standard Classification of
1
Child-Resistant Packages
This standard is issued under the fixed designation D 3475; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.1.3 unit use/single use package—an immediate product
container/package, which may include label directions for use,
1.1 Thisclassificationcoversvarioustypesofchild-resistant
designed in such a manner that each individual product
packages.
package is intended to be opened or used one time separately
1.2 The examples for each type of child-resistant packaging
from the other individual product units in the package, or the
are not intended to be all-inclusive, but are included only as an
entire contents of a single unit package intended for use in one
aid in the understanding and comprehension of each type of
application.
classification.
2.1.3.1 Discussion—These packages are generally non-
1.3 Listings are not to be considered endorsements or
reclosable or non-reusable. A unit of sale package may consist
approval of the package by ASTM.
of one or more non-reusable individual packages. Generally
2. Terminology
used for household, automotive, chemical, pesticide, veteri-
nary, garden and other products not intended for human
2.1 Definitions of Terms Specific to This Standard:
ingestion. Package styles may include some aerosol, that is,
2.1.1 child-resistant package—as defined by the Poison
foggers, soluble film, canisters, pouches, and so forth, filled
Prevention Packaging Act, packaging that is designed or
with liquids, drys, powders, and other product forms. Packages
constructed to be significantly difficult for children under five
may or may not be child-resistant in accordance with the
years of age to open or obtain a toxic or harmful amount of the
regulatory requirements of the package contents.
substance contained therein within a reasonable time, and not
difficult for normal adults to use properly, but does not mean
3. Significance and Use
packaging which all such children cannot open or obtain a
2 3.1 This classification scheme defines the type of motions,
toxic or harmful amount within a reasonable time.
skills, or tools required for a particular type of child-resistant
2.1.2 unit dose package—an immediate product container/
package and provides examples of current packaging within
package designed and labeled in such a manner that each
that type.
individual product package is intended to be opened or used
3.2 Reference to a particular package in this classification is
one time in a generally non-reclosable or non-resealable
not intended in any manner to denote endorsement or approval
manner, separately from the other individual product units in
of the package by ASTM.
the package, or the entire contents of a single unit package
3.3 Packages have been included as examples based on
intended for use in one application.
manufacturers’ claims of child-resistance. Child-resistant
2.1.2.1 Discussion—Normally used for pharmaceutical, hu-
package functionality for any specific product type must be
man healthcare, and nutritional products in dry solid, topical,
determined by the packager/manufacturer following the guide-
transdermal, or liquid form.Aunit of sale package may contain
lines of the PPPA of 1970 and the most current version of the
one or more individual unit dose packages, that is, individually
2
CFR Title 16 Part 1700 and Title 40 Part 157. The listing of
wrapped transdermal patches, pre-filled syringes and syringe
a package in this classification is not an indication of whether
cartridges, blister cards with multiple tablets or capsules, and
or not it has been successfully tested in accordance with the
so forth. Unit dose packages may or may not be child-resistant
aforementioned guidelines.
in accordance with the regulatory requirements of the package
3.4 Additions or deletions to the examples should be re-
contents.
ported to Committee D10 on Packaging, for incorporation into
this classification during the next revision.
1
This classification is under the jurisdiction of ASTM Committee D10 on
Packaging and is the direct responsibility of Subcommittee D10.31 on Child
4. Basis of Classification
Resistant Packaging and Closure Systems.
4.1 The basis for classification for child-resistant closure,
Current edition approved Feb. 1, 2008. Published March 2008. Originally
approved in 1976. Last previous edition approved in 2007 as D 3475 – 07.
and the classifications themselves, appear in Table 1.
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.
Available from U.S. Government Printing Office Superin
...
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:D3475–07 Designation: D 3475 – 08
Standard Classification of
1
Child-Resistant Packages
This standard is issued under the fixed designation D 3475; 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 (e) 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.
1
This classification is under the jurisdiction ofASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.31 on Child Resistant Packaging
and Closure Systems.
Current edition approved AprilFeb. 1, 2007.2008. Published April 2007.March 2008. Originally approved in 1976. Last previous edition approved in 20062007 as
D 3475 – 067.
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. A copy may be obtained through the Superintendent of Documents, U.S. Government Printing
...
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