ASTM D3475-00e1

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Designation: D 3475 – 00
Standard Classification of
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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.
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e NOTE—The word “illustrative” was removed from the text editorially in January 2002.
1. Scope accordance with the regulatory requirements of the package
contents.
1.1 This classification covers various types of child-resistant
2.1.3 unit use/single use package—an immediate product
packages.
container/package, which may include label directions for use,
1.2 The examples for each type of child-resistant packaging
designed in such a manner that each individual product
are not intended to be all-inclusive, but are included only as an
package is intended to be opened or used one time separately
aid in the understanding and comprehension of each type of
from the other individual product units in the package, or the
classification.
entire contents of a single unit package intended for use in one
1.3 Listings are not to be considered endorsements or
application.
approval of the package by ASTM.
2.1.3.1 Discussion—These packages are generally non-
2. Terminology reclosable or non-reusable. A unit of sale package may consist
of one or more non-reusable individual packages. Generally
2.1 Definitions of Terms Specific to This Standard:
used for household, automotive, chemical, pesticide, veteri-
2.1.1 child-resistant package—as defined by the Poison
nary, garden and other products not intended for human
Prevention Packaging Act, packaging that is designed or
ingestion. Package styles may include some aerosol, that is,
constructed to be significantly difficult for children under five
foggers, soluble film, canisters, pouches, etc., filled with
years of age to open or obtain a toxic or harmful amount of the
liquids, drys, powders and other product forms. Packages may
substance contained therein within a reasonable time, and not
or may not be child-resistant in accordance with the regulatory
difficult for normal adults to use properly, but does not mean
requirements of the package contents.
packaging which all such children cannot open or obtain a
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toxic or harmful amount within a reasonable time.
3. Significance and Use
2.1.2 unit dose package—an immediate product container/
3.1 This classification scheme defines the type of motions,
package designed and labeled in such a manner that each
skills, or tools required for a particular type of child-resistant
individual product package is intended to be opened or used
package and provides examples of current packaging within
one time in a generally non-reclosable or non-resealable
that type.
manner, separately from the other individual product units in
3.2 Reference to a particular package in this classification is
the package, or the entire contents of a single unit package
not intended in any manner to denote endorsement or approval
intended for use in one application.
of the package by ASTM.
2.1.2.1 Discussion—Normally used for pharmaceutical, hu-
3.3 Packages have been included as examples based on
man healthcare, and nutritional products in dry solid, topical,
manufacturers’ claims of child-resistance. Child-resistant
transdermal, or liquid form. A unit of sale package may contain
package functionality for any specific product type must be
one or more individual unit dose packages, that is, individually
determined by the packager/manufacturer following the guide-
wrapped transdermal patches, pre-filled syringes and syringe
lines of the PPPA of 1970 and the most current version of the
cartridges, blister cards with multiple tablets or capsules, etc.
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CFR Title 16 Part 1700 and Title 40 Part 157. The listing of
Unit dose packages may or may not be child-resistant in
a package in this classification is not an indication of whether
or not it has been successfully tested in accordance with the
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This classification is under the jurisdiction of ASTM Committee D10 on
aforementioned guidelines.
Packaging and is the direct responsibility of Subcommittee D10.31 on Child-
3.4 Additions or deletions to the examples should be re-
Resistant Packaging.
ported to Committee D10 on Packaging, for incorporation into
Current edition approved Oct. 10, 2000. Published December 2000. Originally
published as D 3475 – 76. Last previous edition D 3475 – 95.
this classification during the next revision.
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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 Office, Washington, DC 20402.
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