1、Designation:F1718aStandard Terminology Relating toPrimary Barrier Packaging1This standard is issued under the fixed designation F17;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indi
2、cates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This terminology covers the principal terms relating toprimary barrier packaging and its materials.This terminologycontains related definitions and descriptions of te
3、rms used orlikely to be used in primary barrier packaging standards.Thepurpose of terminology is to promote clear understanding andinterpretation of the standards in which they are used.1.2 This international standard was developed in accor-dance with internationally recognized principles on standar
4、d-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D883 Terminology Relating to PlasticsD1129 Terminolo
5、gy Relating to WaterF1349 Test Method for Nonvolatile Ultraviolet(UV)Ab-sorbing Extractables from Microwave SusceptorsF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical Devices3.Terminologyaccelerated aginga technique to simulate the effects of timeon a package by subjecting t
6、he product/package system toelevated temperatures in a controlled environment represen-tative of controlled environment storage conditions.Theequivalent time is generally estimated by assuming thedegradation of packaging materials follows the kineticsdescribed by the Arrhenius reaction rate function
7、,morediscussion of which is available in Guide F1980.accumulative pump,na mechanical pump dispenser thataccumulates internal pressure by means of a valving-systemthat maintains a high velocity flow of the product no matterwhat the actuation velocity that results in a consistent finemist spray.acid f
8、oodsfoods that have a natural pH of 4.6 or below.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
9、 adhesive layer that remains with theopposing material,the adhesive having separated eitheradhesively from the coated web or cohesively within theadhesive itself.asepticas applied to aseptic packaging,synonymous withcommercially sterile.aseptic packagingfilling of a commercially sterilized prod-uct
10、into presterilized containers,followed by hermetic seal-ing in a commercially sterile atmosphere.aseptic presentationintroduction and transfer of a sterileproduct using conditions and procedures that exclude micro-bial contamination.atomization,nthe separation process of liquid into smallparticles.b
11、arrierany material limiting passage through itself of solids,liquids,semisolids,gases,vapors,or forms of energy such asultraviolet light.barrier materialsspecialized porous or nonporous packag-ing materials that provide environmental protection to thepackage contents as well as protection to the env
12、ironmentfrom 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 c
13、ontents of the package.biological evaluation test(biotest)a test which involvesexposure of sealed packages to biological indicators and isdesigned to determine the microbiological integrity of apackage under the specific conditions of the test.1This terminology is under the jurisdiction ofASTM Commi
14、ttee F02 on PrimaryBarrier Packaging and is the direct responsibility of F02.50 on Package Design andDevelopment.Current edition approved Oct.1,2018.Published November 2018.Originallyapproved in 1961.Last previous edition approved in 2018 as F17 18.DOI:10.1520/F0017-18A.2For referenced ASTM standard
15、s,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.
16、United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 burst strengtha measure of the internal pressure necessaryto rupture a package or seal.channelany unimpaired pathway across the entire width ofthe intended seal.clogging,v
