ASTM D3475-18
(Classification)Standard Classification of Child-Resistant Packages
Standard Classification of Child-Resistant Packages
SIGNIFICANCE AND USE
3.1 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.
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 of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 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 Subcommittee F02.50 on Package Design and Development, for incorporation into this classification during the next revision.
3.5 Additions require F02.50 Task Group review of CFR Title 16 Part 1700 full protocol testing reports. Reports should cover procedures and all CFR Title 16 Part 1700 required reporting elements. Additional information may be requested.
3.6 Use of a package cited in this classification allows for the statement “CONFORMS TO ASTM D3475,” and does not allow for the use of the ASTM logo or result in an ASTM certification mark.
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.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation:D3475 −18
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 2.1.2.1 Discussion—Normally used for pharmaceutical, hu-
man healthcare, and nutritional products in dry solid, topical,
1.1 Thisclassificationcoversvarioustypesofchild-resistant
transdermal, or liquid form.Aunit of sale package may contain
packages.
one or more individual unit dose packages, that is, individually
1.2 The examples for each type of child-resistant packaging
wrapped transdermal patches, pre-filled syringes and syringe
are not intended to be all-inclusive, but are included only as an
cartridges, blister cards with multiple tablets or capsules, and
aid in the understanding and comprehension of each type of
so forth. Unit dose packages may or may not be child-resistant
classification.
in accordance with the regulatory requirements of the package
1.3 Listings are not to be considered endorsements or
contents.
approval of the package by ASTM.
2.1.3 unit use/single use package—an immediate product
1.4 This international standard was developed in accor-
container/package, which may include label directions for use,
dance with internationally recognized principles on standard-
designed in such a manner that each individual product
ization established in the Decision on Principles for the
package is intended to be opened or used one time separately
Development of International Standards, Guides and Recom-
from the other individual product units in the package, or the
mendations issued by the World Trade Organization Technical
entire contents of a single unit package intended for use in one
Barriers to Trade (TBT) Committee.
application.
2.1.3.1 Discussion—These packages are generally non-
2. Terminology
reclosable or non-reusable. A unit of sale package may consist
2.1 Definitions of Terms Specific to This Standard:
of one or more non-reusable individual packages. Generally
2.1.1 child-resistant package—as defined by the Poison
used for household, automotive, chemical, pesticide,
Prevention Packaging Act, packaging that is designed or
veterinary, garden and other products not intended for human
constructed to be significantly difficult for children under five
ingestion. Package styles may include some aerosol, that is,
years of age to open or obtain a toxic or harmful amount of the
foggers, soluble film, canisters, pouches, and so forth, filled
substance contained therein within a reasonable time, and not
withliquids,dries,powders,andotherproductforms.Packages
difficult for normal adults to use properly, but does not mean
may or may not be child-resistant in accordance with the
packaging which all such children cannot open or obtain a
regulatory requirements of the package contents.
2
toxic or harmful amount within a reasonable time.
2.1.2 unit dose package—an immediate product container/
3. Significance and Use
package designed and labeled in such a manner that each
3.1 This classification scheme defines the type of motions,
individual product package is intended to be opened or used
skills, or tools required for a particular type of child-resistant
one time in a generally non-reclosable or non-resealable
package and provides examples of current packaging within
manner, separately from the other individual product units in
that type.
the package, or the entire contents of a single unit package
intended for use in one application.
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.
1
This classification is under the jurisdiction of ASTM Committee F02 on
Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50
3.3 Packages have been included as examples based on
on Package Design and Development.
manufacturers’ claims of child-resistance. Child-resistant
Current edition approved April 15, 2018. Published June 2018. Originally
package functionality for any specific product type must be
approved in 1976. Last previous edition approved in 2018 as D3475 – 18. DOI:
10.1520/D3475-18.
determined by the packager/manufacturer following the guide-
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157.
lines of the PPPA of 1970 and the most current version of the
Available from U.S. Government Printing Office Superintendent of Documents, 732
2
CFR Title 16 Part 1700 and Title 40 Part 157. The listing of
N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov. a pac
...
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 − 17 D3475 − 18
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.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 wrapped transdermal patches,
pre-filled syringes and syringe cartridges, blister cards with multiple tablets or capsules, and so forth. 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,
designed in such a manner that each individual product package is intended to be opened or used one time 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.
2.1.3.1 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, dries, powders, and other product forms. Packages may or may not be child-resistant in accordance with
the regulatory requirements of the package contents.
1
This classification is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package
Design and Development.
Current edition approved March 1, 2017April 15, 2018. Published April 2017June 2018. Originally approved in 1976. Last previous edition approved in 20162018 as
D3475 – 16.D3475 – 18. DOI: 10.1520/D3475-17.10.1520/D3475-18.
2
Code of Federal Regulations, Title 16, Part 1700 and Title 40, Part 157. Available from U.S. Government Printing Office Superintendent of Documents, 732 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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D3475 − 18
3. Significance and Use
3.1 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package
and provides examples of curre
...
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