ASTM D3475-03a
(Classification)Standard Classification of Child-Resistant Packages
Standard Classification of Child-Resistant Packages
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 – 03a
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, etc., filled with
Prevention Packaging Act, packaging that is designed or
liquids, drys, powders and other product forms. Packages may
constructed to be significantly difficult for children under five
or may not be child-resistant in accordance with the regulatory
years of age to open or obtain a toxic or harmful amount of the
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, etc.
or not it has been successfully tested in accordance with the
Unit dose packages may or may not be child-resistant in
aforementioned guidelines.
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.
4.1 The basis for classification for child-resistant closure,
Current edition approved Oct. 1, 2003. Published December 2003. Originally
and the classifications themselves, appear in Table 1.
approved in 1976. Last previous edition approved in 2003 as D 3475 – 03.
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.Acopy
may be obtained through the Superintendent of Documents, U.S. Government
Printing
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