ASTM F1327-98
(Terminology)Standard Terminology Relating to Barrier Materials for Medical Packaging
Standard Terminology Relating to Barrier Materials for Medical Packaging
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.
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Standards Content (Sample)
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Designation:F1327–98
Standard Terminology Relating to
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 preventing the passage of microorganisms that might con-
taminate the contents of the package.
1.1 This terminology contains related definitions and de-
biological evaluation test (biotest)—See Terminology F 17.
scriptions of terms used or likely to be used in medical
burst strength—a measure of the internal pressure necessary
packaging standards that involve barrier materials. The pur-
to rupture a package or seal.
pose of terminology is to promote clear understanding and
channel—any unimpaired pathway across the entire width of
interpretation of the standards in which they are used.
the intended seal.
2. Referenced Document coextrusion—See Terminology F 17.
delamination—See Terminology F 17.
2.1 ASTM Standards:
dispersion coating— See Terminology F 17.
F 17 Terminology Relating to Flexible Barrier Materials
extrusion coating— See Terminology F 17.
3. Terminology Definitions
flexible—See Terminology F 17.
fusion seal—See Terminology F 17.
accelerated aging—a technique to simulate the effects of
heat seal—the result of bonding surfaces by controlled appli-
package aging by subjecting the product/package system to
cation of heat, pressure, and dwell time.
environmental stress; generally accomplished using tem-
hermetically sealed aseptic container—See Terminology F 17.
perature and humidity extremes, depending on application;
laminate—See Terminology F 17.
other environmental elements, for example, ultraviolet light,
lamination—See Terminology F 17.
may have to be considered.
leak—any opening in a flexible package that is contrary to
adhesive transfer—a condition occurring when an adhesive-
intention and either lets contents escape or permits sub-
coated material is peeled away from an opposing material to
stances to enter.
which it has been sealed and shows visible evidence of the
major package defect— See Terminology F 17.
adhesive being left on the opposing material. This evidence
microbial contamination— See Terminology F 17.
is in the form of an adhesive layer that remains with the
minor package defect— See Terminology F 17.
opposing material, the adhesive having separated either
multilayered structure— See Terminology F 17.
adhesively from the coated web or cohesively within the
package integrity—the physical capability of a given package
adhesive itself.
to protect its contents with the desired level of protection
aseptic packaging— See Terminology F 17.
over a defined period of service; for example, as a barrier
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