ASTM_F_1327_-_98.pdf

Designation:F 1327 98Standard Terminology Relating toBarrier Materials for Medical Packaging1This standard is issued under the fixed designation F 1327;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This terminology contains related definitions and de-scriptions of terms used or likely to be used in medicalpackaging standards that involve barrier materials.The pur-pose of terminology is to promote clear understanding andinterpretation of the standards in which they are used.2.Referenced Document2.1 ASTM Standards:F 17 Terminology Relating to Flexible Barrier Materials23.Terminology Definitionsaccelerated aginga technique to simulate the effects ofpackage aging by subjecting the product/package system toenvironmental stress;generally accomplished using tem-perature and humidity extremes,depending on application;other environmental elements,for example,ultraviolet light,may have to be considered.adhesive transfera condition occurring when an adhesive-coated material is peeled away from an opposing material towhich it has been sealed and shows visible evidence of theadhesive being left on the opposing material.This evidenceis in the form of an adhesive layer that remains with theopposing material,the adhesive having separated eitheradhesively from the coated web or cohesively within theadhesive itself.aseptic packaging See Terminology F 17.barrierSee Terminology F 17.barrier materialsspecialized porous or nonporous packag-ing materials that provide environmental protection to thepackage contents as well as protection to the environmentfrom the package contents:(1)gas,vapor,humidity,liquid,microbial,or light resistant materials that control or elimi-nate the amount of those environmental constituents thatpass into or out of a package;(2)a porous materialpreventing the passage of microorganisms that might con-taminate the contents of the package.biological evaluation test(biotest)See Terminology F 17.burst strengtha measure of the internal pressure necessaryto rupture a package or seal.channelany unimpaired pathway across the entire width ofthe intended seal.coextrusionSee Terminology F 17.delaminationSee Terminology F 17.dispersion coating See Terminology F 17.extrusion coating See Terminology F 17.flexibleSee Terminology F 17.fusion sealSee Terminology F 17.heat sealthe result of bonding surfaces by controlled appli-cation of heat,pressure,and dwell time.hermetically sealed aseptic containerSee Terminology F 17.laminateSee Terminology F 17.laminationSee Terminology F 17.leakany opening in a flexible package that is contrary tointention and either lets contents escape or permits sub-stances to enter.major package defect See Terminology F 17.microbial contamination See Terminology F 17.minor package defect See Terminology F 17.multilayered structure See Terminology F 17.package integritythe physical capability of a given packageto protect its contents with the desired level of protectionover a defined period of service;for example,as a barrier tophysical,microbiological,or chemical challenges.peelable sealthe opening characteristic of forcibly separat-ing two package substrates,which have been joined togetherby a sealing process,without tearing the substrates.porous packaging materiala material used in medicalpackaging which is intended to provide an environmentaland biological barrier,while allowing sufficient air flow to beused in gaseous sterilization methods(for example,EtO,steam,gas plasma).retortableSee Terminology F 17.sealSee Terminology F 17.seal contamination See Terminology F 17.seal creepthe reduction in width of a seal due to a forcebeing exerted on it,such as a bulky product,pouch distor-tion,or internal air pressure.seal creep resistancea measure of the ability of a sealedpackage or seal to remain intact when subjected to a constantforce.seal strengtha measure of the mechanical strength of thebond between sealed materials of a package.seamSee Terminology F 17.1This terminology is under the jurisdiction ofASTM Committee F-2 on FlexibleBarrier Materials and is the direct responsibility of Subcommittee F02.60 onMedical Packaging.Current edition approved April 10,1998.Published December 1998.Originallypublished as F 1327 91.Last previous edition F 1327 96.2Annual Book of ASTM Standards,Vol 15.09.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.solution coatingSee Terminology F 17.sterilantSee Terminology F 17.sterileSee Terminology F 17.thermal processing See Terminology F 17.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised,either reapproved or withdrawn.Your comments are invited either for revision of this standard or f