1、Designation:F 1585 00Standard Guide forIntegrity Testing of Porous Barrier Medical Packages1This standard is issued under the fixed designation F 1585;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number
2、 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 guide covers general procedures for conductingcontrolled tests for determining the integrity of porous barriermedical packages.These proced
3、ures are intended to be a guidein determining overall package integrity and are not intended tobe used by themselves in determining component materialsuitability.Material specifications should be written for eachcomponent,and a complete battery of tests should be per-formed to determine its suitabil
4、ity.1.2 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 D
5、ocuments2.1 ASTM Standards:D 903 Test Method for Peel or Stripping Strength of Adhe-sive Bonds2D 996 Terminology of Packaging and Distribution Environ-ments3D 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble Emission3D 4169 Practice for Performance Testing of Shipping Con-t
6、ainers and Systems3D 4332 Practice for Conditioning Containers,Packages,orPackage Components for Testing3E 122 Practice for Choice of Sample Size to Estimate aMeasure of Quality for a Lot or Process4E 515 Test Method for Leaks Using Bubble Emission Tech-niques5E 1316 Terminology for Nondestructive E
7、xaminations5F 17 Terminology Relating to Flexible Barrier Materials3F 88 Test Method for Seal Strength of Flexible BarrierMaterials3F 1140 Test Methods for Failure Resistance of Unrestrainedand Nonrigid Packages for Medical Applications3F 1327 Terminology Relating to Barrier Materials for Medi-cal P
8、ackaging3F 1608 Test Method for Microbial Ranking of Porous Pack-aging Materials(Exposure Chamber Method)3F 1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual Inspection3F 1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye Penetration3F 1980 G
9、uide for Accelerated Aging of Sterile MedicalDevice Packages33.Terminology3.1 Definitions:3.1.1 Applicable definitions and terminology may be foundin Terminologies D 996,E 1316,F 17,and F 1327.4.Significance and Use4.1 Maintaining the integrity of a porous barrier medicalpackage is critical to the d
10、elivery of a sterile product.Thisguide provides for the evaluation of the integrity of porousbarrier medical packages,using established test methods.Damaged packages,substandard materials,inadequate seals,ora combination thereof,may cause a package to fail duringmanufacture,sterilization,distributio
11、n,storage,or use.Whenusing the tests presented in this guide as part of a qualificationtest plan,process validation plan,or quality control program,some of the factors to consider are as follows:4.1.1 PorosityPorous barrier materials are designed toallow for the transmission of gases.Their porosity
12、rates,consistency,uniformity,and the effect that coatings or labelshave on their overall porosity can change the uniformity ofperformance characteristics and results.4.1.2 LeaksSmall leaks may be hard to detect.The effectsof the porous barrier material,the product,entrapped air,andthe test parameter
13、s selected,may be significant and make thedetection of small leaks very difficult.4.1.3 Physical HandlingsThe number and severity ofphysical handlings during manufacture,sterilization,and dis-tribution.4.1.4 Sealing ProcessThe parameters and tolerances suchas temperature,dwell time,and pressure.4.1.
14、5 Distribution Requirements.4.1.6 Shelf Life Requirement,utilizing real time or acceler-ated aging techniques.4.1.7 Maintenance of Package IntegrityThe requirements1This guide is under the jurisdiction of ASTM Committee F-2 on FlexibleBarrier Materials and is the direct responsibility of Subcommitte
15、e F02.60 onMedical Packaging.Current edition approved April 10,2000.Published June 2000.Originallypublished as F 1585 95.Last previous edition F 1585 95.2Annual Book of ASTM Standards,Vol 15.06.3Annual Book of ASTM Standards,Vol 15.09.4Annual Book of ASTM Standards,Vol 14.02.5Annual Book of ASTM Sta
16、ndards,Vol 03.03.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.associated with the maintenance of package integrity need tobe defined.4.1.8 Sterilization ProcessThe sterilization process cho-sen may indicate the type of tests to be performed.Forinstance,in the case where there are substantial pressurechanges during the sterilization process,it will be necessary toexamine the package seals for degradation or failure from theaffects of the pressure changes.Cer