ASTM F17-20

Standard Terminology Relating to Primary Barrier Packaging

SCOPE
1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.  
1.2 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: 30-Apr-2020
• ICS: 01.040.55 - Packaging and distribution of goods (Vocabularies)
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.50 - Package Design and Development

Relations

• Referred By: ASTM F2824-10(2020) - Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
• Effective Date: 01-May-2020
• Referred By: ASTM E171/E171M-11(2020) - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
• Effective Date: 01-May-2020
• Referred By: ASTM D996-23 - Standard Terminology of Packaging and Distribution Environments
• Effective Date: 01-May-2020
• Referred By: ASTM F2054/F2054M-13(2020) - Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
• Effective Date: 01-May-2020
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-May-2020
• Referred By: ASTM F1140/F1140M-13(2020)e1 - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
• Effective Date: 01-May-2020
• Referred By: ASTM F2095-07(2021) - Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
• Effective Date: 01-May-2020
• Referred By: ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
• Effective Date: 01-May-2020
• Referred By: ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
• Effective Date: 01-May-2020
• Referred By: ASTM F2338-09(2020) - Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
• Effective Date: 01-May-2020
• Referred By: ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
• Effective Date: 01-May-2020
• Referred By: ASTM E398-20 - Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
• Effective Date: 01-May-2020
• Referred By: ASTM F88/F88M-23 - Standard Test Method for Seal Strength of Flexible Barrier Materials
• Effective Date: 01-May-2020
• Referred By: ASTM F2391-22 - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
• Effective Date: 01-May-2020
• Referred By: ASTM F2228-13(2021) - Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> Tracer Gas Method
• Effective Date: 01-May-2020

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: F17 − 20
Standard Terminology Relating to
1
Primary Barrier Packaging
This standard is issued under the fixed designation F17; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope accumulative pump, n—a mechanical pump dispenser that
accumulates internal pressure by means of a valving-system
1.1 This terminology covers the principal terms relating to
that maintains a high velocity flow of the product no matter
primary barrier packaging and its materials. This terminology
what the actuation velocity that results in a consistent fine
contains related definitions and descriptions of terms used or
mist spray.
likely to be used in primary barrier packaging standards. The
purpose of terminology is to promote clear understanding and
acid foods—foods that have a natural pH of 4.6 or below.
interpretation of the standards in which they are used.
adhesive transfer—a condition occurring when an adhesive-
1.2 This international standard was developed in accor-
coated material is peeled away from an opposing material to
dance with internationally recognized principles on standard-
which it has been sealed and shows visible evidence of the
ization established in the Decision on Principles for the
adhesive being left on the opposing material. This evidence
Development of International Standards, Guides and Recom-
is in the form of an adhesive layer that remains with the
mendations issued by the World Trade Organization Technical
opposing material, the adhesive having separated either
Barriers to Trade (TBT) Committee.
adhesively from the coated web or cohesively within the
adhesive itself.
2. Referenced Documents
aseptic—as applied to aseptic packaging, synonymous with
2
2.1 ASTM Standards:
commercially sterile.
D883 Terminology Relating to Plastics
aseptic packaging—filling of a commercially sterilized prod-
D1129 Terminology Relating to Water
uct into presterilized containers, followed by hermetic seal-
F1349 Test Method for Nonvolatile Ultraviolet (UV) Ab-
ing in a commercially sterile atmosphere.
sorbing Extractables from Microwave Susceptors
F1980 Guide for Accelerated Aging of Sterile Barrier Sys-
aseptic presentation—introduction and transfer of a sterile
tems for Medical Devices
product using conditions and procedures that exclude micro-
bial contamination.
3. Terminology
atomization, n—the separation process of liquid into small
accelerated aging—a technique to simulate the effects of time particles.
on a package by subjecting the product/package system to
barrier—anymateriallimitingpassagethroughitselfofsolids,
elevated temperatures in a controlled environment represen-
liquids,semisolids,gases,vapors,orformsofenergysuchas
tative of controlled environment storage conditions. The
ultraviolet light.
equivalent time is generally estimated by assuming the
barrier materials—specialized porous or nonporous packag-
degradation of packaging materials follows the kinetics
described by the Arrhenius reaction rate function, more ing materials that provide environmental protection to the
discussion of which is available in Guide F1980. package contents as well as protection to the environment
from the package contents: (1) gas, vapor, humidity, liquid,
microbial, or light resistant materials that control or elimi-
nate the amount of those environmental constituents that
1
ThisterminologyisunderthejurisdictionofASTMCommitteeF02onPrimary
pass into or out of a package; (2) a porous material
Barrier Packaging and is the direct responsibility of F02.50 on Package Design and
Development. preventing the passage of microorganisms that might con-
Current edition approved May 1, 2020. Published August 2020. Originally
taminate the contents of the package.
approved in 1961. Last previous edition approved in 2018 as F17 – 18a. DOI:
10.1520/F0017-20.
biological evaluation test (biotest)—a test which involves
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
exposure of sealed packages to biological indicators and is
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
designed to determine the microbiological integrity of a
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. package under the specific conditions of the test.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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...

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: F17 − 18a F17 − 20
Standard Terminology Relating to
1
Primary Barrier Packaging
This standard is issued under the fixed designation F17; 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 terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology
contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose
of terminology is to promote clear understanding and interpretation of the standards in which they are used.
1.2 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. Referenced Documents
2
2.1 ASTM Standards:
D883 Terminology Relating to Plastics
D1129 Terminology Relating to Water
F1349 Test Method for Nonvolatile Ultraviolet (UV) Absorbing Extractables from Microwave Susceptors
F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
3. Terminology
accelerated aging—a technique to simulate the effects of time on a package by subjecting the product/package system to elevated
temperatures in a controlled environment representative of controlled environment storage conditions. The equivalent time is
generally estimated by assuming the degradation of packaging materials follows the kinetics described by the Arrhenius reaction
rate function, more discussion of which is available in Guide F1980.
accumulative pump, n—a mechanical pump dispenser that accumulates internal pressure by means of a valving-system that
maintains a high velocity flow of the product no matter what the actuation velocity that results in a consistent fine mist spray.
acid foods—foods that have a natural pH of 4.6 or below.
adhesive transfer—a condition occurring when an adhesive-coated material is peeled away from an opposing material to which
it has been sealed and shows visible evidence of the adhesive being left on the opposing material. This evidence is in the form
of an adhesive layer that remains with the opposing material, the adhesive having separated either adhesively from the coated
web or cohesively within the adhesive itself.
aseptic—as applied to aseptic packaging, synonymous with commercially sterile.
aseptic packaging—filling of a commercially sterilized product into presterilized containers, followed by hermetic sealing in a
commercially sterile atmosphere.
aseptic presentation—introduction and transfer of a sterile product using conditions and procedures that exclude microbial
contamination.
atomization, n—the separation process of liquid into small particles.
1
This terminology is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of F02.50 on Package Design and
Development.
Current edition approved Oct. 1, 2018May 1, 2020. Published November 2018August 2020. Originally approved in 1961. Last previous edition approved in 2018 as
F17 – 18.F17 – 18a. DOI: 10.1520/F0017-18A.10.1520/F0017-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F17 − 20
barrier—any material limiting passage through itself of solids, liquids, semisolids, gases, vapors, or forms of energy such as
ultraviolet light.
barrier materials—specialized porous or nonporous packaging materials that provide environmental protection to the package
contents as well as protection to the environment from the package contents: (1) gas, vapor, humidity, liquid, microbial, or light
resistant materials that control or eliminate the amount of those environmental constituents that pass into or out of a package;
(2) a porous material preventing the passage of microorganisms that might contaminate the contents of the package.
biolo
...