ASTM F3375-19

Standard Test Method for Assessing Non-Metered Restricted Delivery Systems for Liquid Consumer Products

SIGNIFICANCE AND USE
5.1 Despite child-resistant packaging requirements for most potentially harmful liquid consumer products, each year tens of thousands of young children are evaluated in emergency departments for potential poisoning from liquid consumer products. Products that use reclosable safety packaging rely on users to resecure the child-resistant closure fully after each use. If the closure is not fully secured or a child opens the closure, the entirety of the product contents is immediately accessible. Restricted delivery systems are a type of packaging for medications and other liquid consumer products designed to limit the amount of product that is accessible even after the primary closure is removed.  
5.2 This test method can be used to provide quantitative assessment of restricted delivery systems for liquid consumer products. This test method outlines three types of mechanical test procedures to simulate methods young children may use when attempting to access liquid contents from a container. To evaluate the efficacy of restricted delivery systems, tests are conducted with the primary closure removed and under conditions approximating intended use of the products. Instruction for use for the intended product should be used when preparing the samples for testing; for example, storage temperature, shaking of product, and use of associated dispensing devices when applicable.
SCOPE
1.1 This test method covers assessment of non-metered restricted delivery system characteristics so that they can be evaluated to a standard that signifies efficacy in limiting accessibility of liquid contents to young children.  
1.2 This test method provides general test conditions for the determination of flow control of liquids by restricted delivery systems using mechanical testing to simulate methods that may be used to access liquid consumer products by young children.  
1.3 The test parameters provided within this test method are estimates based on existing literature and experience. The estimated values are intended to allow comparison of performance characteristics across different restricted delivery systems.  
1.4 This test method applies to liquids packaged in reclosable containers.
Note 1: Since there are many variables that may affect release of liquid (for example, rigidity of container, viscosity of liquid contents, or variation in test equipment), it is important that the entire restricted delivery system is tested together as intended for use while using the same or similar testing equipment. This test method does not address other product characteristics that might be affected by use of restricted delivery systems (for example, uniformity of active ingredient throughout duration of use).  
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

General Information

• Status: Published
• Publication Date: 14-Apr-2019
• ICS: 55.100 - Bottles. Pots. Jars
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.30 - Mechanical Dispensers

Standards Content (Sample)

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.
Designation: F3375 − 19
Standard Test Method for
Assessing Non-Metered Restricted Delivery Systems for
1
Liquid Consumer Products
This standard is issued under the fixed designation F3375; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method covers assessment of non-metered
mendations issued by the World Trade Organization Technical
restricted delivery system characteristics so that they can be
Barriers to Trade (TBT) Committee.
evaluated to a standard that signifies efficacy in limiting
accessibility of liquid contents to young children.
2. Referenced Documents
1.2 This test method provides general test conditions for the 2
2.1 ASTM Standards:
determination of flow control of liquids by restricted delivery
D7778 Guide for Conducting an Interlaboratory Study to
systemsusingmechanicaltestingtosimulatemethodsthatmay
Determine the Precision of a Test Method
be used to access liquid consumer products by young children.
E177 Practice for Use of the Terms Precision and Bias in
1.3 The test parameters provided within this test method are ASTM Test Methods
estimates based on existing literature and experience. The E691 Practice for Conducting an Interlaboratory Study to
estimated values are intended to allow comparison of perfor- Determine the Precision of a Test Method
mance characteristics across different restricted delivery sys-
3. Terminology
tems.
3.1 Definitions of Terms Specific to This Standard:
1.4 This test method applies to liquids packaged in reclos-
3.1.1 restricted delivery system, n—packaging system de-
able containers.
signed to limit the amount of contents that can be accessed by
NOTE 1—Since there are many variables that may affect release of
liquid (for example, rigidity of container, viscosity of liquid contents, or young children (<6 years of age).
variation in test equipment), it is important that the entire restricted
3.1.1.1 Discussion—For liquid consumer products, the re-
delivery system is tested together as intended for use while using the same
stricted delivery system includes the liquid contents, container
or similar testing equipment. This test method does not address other
(for example, bottle), and any additional container components
product characteristics that might be affected by use of restricted delivery
to limit flow (for example, components attached to the con-
systems (for example, uniformity of active ingredient throughout duration
of use). tainer orifice, including press-in bottle adapters).
1.5 Units—The values stated in either SI units or inch-
4. Summary of Test Method
pound units are to be regarded separately as standard. The
4.1 Three mechanical test procedures are used to assess
values stated in each system may not be exact equivalents;
efficacy of restricted delivery systems in limiting unintentional
therefore,eachsystemshallbeusedindependentlyoftheother.
access to liquid consumer products by young children. Test
Combining values from the two systems may result in noncon-
procedures are intended to simulate methods that young
formance with the standard.
children may use to access liquid products from containers.All
1.6 This standard does not purport to address all of the
components of the restricted delivery system are tested to-
safety concerns, if any, associated with its use. It is the
gether and the amount of liquid released is recorded for each
responsibility of the user of this standard to establish appro-
procedure.
priate safety, health, and environmental practices and deter-
4.1.1 Deceleration—To simulate shaking the container;
mine the applicability of regulatory limitations prior to use.
“swing test.”
1.7 This international standard was developed in accor-
4.1.2 Application of Force—To simulate squeezing the con-
dance with internationally recognized principles on standard-
tainer; “squeeze test.”
1
This test method is under the jurisdiction ofASTM Committee F02 on Primary
2
Barrier Packaging and is the direct responsibility of Subcommittee F02.30 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Mechanical Dispensers. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved April 15, 2019. Published June 2019. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summar
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