ASTM_F_2559_-_F_2559M_-_06_2015.pdf

Designation:F2559/F2559M06(Reapproved 2015)Standard Guide forWriting a Specification for Sterilizable Peel Pouches1This standard is issued under the fixed designation F2559/F2559M;the number immediately following the designation indicates the yearof 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.Scope1.1 This guide defines the requirements and considerationsfor flexible peel pouches with one open,unsealed end that areintended to be sterilized containing medical devices.These arealso known as preformed sterile barrier systems.1.2 Pouch styles are categorized as chevron,header,andcorner peel.These pouches are typically manufactured by heatsealing,or in some cases,by cohesive cold sealing.The sealingbond is intended to be peeled open to aseptically dispense thecontents.1.3 Pouch materials may be either porous,nonporous,orany combination of the two.1.4 This guide addresses some critical printing requirementson the pouch.1.5 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF1140 Test Methods for Internal Pressurization Failure Re-sistance of Unrestrained PackagesF1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF2054 Test Method for Burst Testing of Flexible PackageSeals Using InternalAir Pressurization Within RestrainingPlatesF2097 Guide for Design and Evaluation of Primary FlexiblePackaging for Medical ProductsF2203 Test Method for Linear Measurement Using PrecisionSteel RuleF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging Materi-alsF2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging Materials2.2 TAPPI Standards:T437 Dirt in Paper and Paperboard33.Terminology3.1 DefinitionsFor definitions and terms used in thisguide,see Terminology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 pouch,na flexible package constructed of one ormore materials sealed together to form a preformed sterilebarrier system.When purchased,one end or side is open toallow for product loading and final sealing.3.2.2 specification,nan explicit set of requirements to besatisfied by a material,product,system,or service.Examplesof specifications include,but are not limited to,requirementsfor;physical,mechanical,or chemical properties,and safety,quality,or performance criteria.A specification identifies thetest methods for determining whether each of the requirementsis satisfied.44.Summary4.1 This guide provides guidance for writing a peel pouchmaterial specification.Materials,method of manufacture,1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Oct.1,2015.Published October 2015.Originallyapproved in 2006.Last previous edition approved in 2010 as F2559/F2559M-06(2010)1.DOI:10.1520/F2559_F2559M-06R15.2For referenced ASTM standards,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.3Available from Technical Association of the Pulp and Paper Industry(TAPPI),15 Technology Parkway South,Norcross,GA 30092,http:/www.tappi.org.4In accordance with ASTM International Form and Style for ASTM Standards.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 physical properties,performance requirements,dimensioning,appearance,and printing are all issues that need to be ad-dressed in a peel pouch specification.Appropriate requirementsand test methods are suggested for preparing a specification.5.Significance and Use5.1 Medical device peel pouches are universally used by theindustry and produced by a myriad of suppliers.They may beconstructed of many different materials including films,foils,paper,nonwovens such as Tyvek,and combinations thereof.However,even with the diversity of materials,ther