ASTM F1327-05

Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)

SCOPE
1.1 This terminology contains related definitions and descriptions of terms used or likely to be used in medical packaging standards that involve barrier materials. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.
WITHDRAWN RATIONALE
This terminology contains related definitions and descriptions of terms used or likely to be used in medical packaging standards that involve barrier materials. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used.
Formerly under the jurisdiction of Committee F02 on Flexible Barrier Packaging, this terminology was withdrawn in April 2007 and replaced by Terminology F17 Relating to Flexible Barrier Materials.
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.

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2005
• Withdrawal Date: 31-Mar-2007
• 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

• Replaces: ASTM F1327-98 - Standard Terminology Relating to Barrier Materials for Medical Packaging
• Effective Date: 01-Apr-2005
• 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-Apr-2005
• Referred By: ASTM F2227-13(2021) - Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO<inf>2</inf> Tracer Gas Method
• Effective Date: 01-Apr-2005
• Referred By: ASTM D4169-22 - Standard Practice for Performance Testing of Shipping Containers and Systems
• Effective Date: 01-Apr-2005
• Referred By: ASTM F2338-09(2020) - Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
• Effective Date: 01-Apr-2005

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1327–05
Standard Terminology Relating to
1
Barrier Materials for Medical Packaging
This standard is issued under the fixed designation F 1327; 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 barrier materials—specialized porous or nonporous packag-
ing materials that provide environmental protection to the
1.1 This terminology contains related definitions and de-
package contents as well as protection to the environment
scriptions of terms used or likely to be used in medical
from the package contents: (1) gas, vapor, humidity, liquid,
packaging standards that involve barrier materials. The pur-
microbial, or light resistant materials that control or elimi-
pose of terminology is to promote clear understanding and
nate the amount of those environmental constituents that
interpretation of the standards in which they are used.
pass into or out of a package; ( 2) a porous material
2. Referenced Document preventing the passage of microorganisms that might con-
2
taminate the contents of the package.
2.1 ASTM Standards:
biological evaluation test (biotest)—See TerminologyF17.
F17 Terminology Relating to Flexible Barrier Materials
burst strength—a measure of the internal pressure necessary
F 1980 Guide for Accelerated Aging of Sterile Medical
to rupture a package or seal.
Device Packages
channel—any unimpaired pathway across the entire width of
3. Terminology Definitions
the intended seal.
coextrusion—See TerminologyF17.
accelerated aging—a technique to simulate the effects of time
delamination—See TerminologyF17.
on a package by subjecting the product/package system to
dispersion coating— See TerminologyF17.
elevated temperatures in a controlled environment represen-
environmental challenging—the process of subjecting a
tative of controlled environment storage conditions. The
package to extremes of temperature, or humidity, or both,
equivalent time is generally estimated by assuming the
with the goal of determining sensitivities of the package to
degradation of packaging materials follows the kinetics
environmental stresses. In contrast to accelerated aging,
described by the Arrhenius reaction rate function, more
environmental challenging often includes conditions, or
discussion of which is available in Guide F 1980.
transitions, or both, of temperature and humidity that equal
adhesive transfer—a condition occurring when an adhesive-
or exceed those that can be encountered in a package life
coated material is peeled away from an opposing material to
cycle.
which it has been sealed and shows visible evidence of the
extrusion coating— See TerminologyF17.
adhesive being left on the opposing material. This evidence
flexible—See TerminologyF17.
is in the form of an adhesive layer that remains with the
fusion seal—See TerminologyF17.
opposing material, the adhesive having separated either
heat seal—the result of bonding surfaces by controlled appli-
adhesively from the coated web or cohesively within the
cation of heat, pressure, and dwell time.
adhesive itself.
hermetically sealed aseptic container—See TerminologyF17.
aseptic
...