ASTM D3475-00
(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.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: D 3475 – 00
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 This classification covers various types of child-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 illustrative examples for each type of child-resistant
from the other individual product units in the package, or the
packaging are not intended to be all-inclusive, but are included
entire contents of a single unit package intended for use in one
only as an aid in the understanding and comprehension of each
application.
type of 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 illustrative examples of current packag-
package designed and labeled in such a manner that each
ing within 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 illustrative examples
intended for use in one application.
based on manufacturers’ claims of child-resistance. Child-
2.1.2.1 Discussion—Normally used for pharmaceutical, hu-
resistant package functionality for any specific product type
man healthcare, and nutritional products in dry solid, topical,
must be determined by the packager/manufacturer following
transdermal, or liquid form. A unit of sale package may contain
the guidelines of the PPPA of 1970 and the most current
one or more individual unit dose packages, that is, individually
2
version of the CFR Title 16 Part 1700 and Title 40 Part 157.
wrapped transdermal patches, pre-filled syringes and syringe
The listing of a package in this classification is not an
cartridges, blister cards with multiple tablets or capsules, etc.
indication of whether or not it has been successfully tested in
Unit dose packages may or may not be child-resistant in
accordance with the aforementioned guidelines.
accordance with the regulatory requirements of the package
3.4 Additions or deletions to the illustrative examples
contents.
should be reported 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.
Current edition approved Oct. 10, 2000. Published December 2000. Originally
4.1 The basis for classification for child-resistant closure,
published as D 3475 – 76. Last previous edition D 3475 – 95.
and the classifications themselves, appear in Table 1.
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. A copy
may be obtained through the S
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.