1、Designation:F198007(Reapproved 2011)Standard Guide forAccelerated Aging of Sterile Barrier Systems for MedicalDevices1This standard is issued under the fixed designation F1980;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year
2、of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide provides information for developing accel-erated aging protocols to rapidly determine the effects,if any,due
3、to the passage of time on the sterile integrity of the sterilebarrier system(SBS),as defined in ANSI/AAMI/ISO116071:2006 and the physical properties of their componentpackaging materials.1.2 Information obtained using this guide may be used tosupport expiration date claims for medical device sterile
4、 barriersystems.1.3 The accelerated aging guideline addresses the sterilebarrier systems in whole with or without devices.The sterilebarrier system material and device interaction compatibilitythat may be required for new product development or theresulting evaluation is not addressed in this guide.
5、1.4 Real-time aging protocols are not addressed in thisguide;however,it is essential that real-time aging studies beperformed to confirm the accelerated aging test results usingthe same methods of evaluation.1.5 Methods used for sterile barrier system validation,which include the machine process,the
6、 effects of the steriliza-tion process,environmental challenge,distribution,handling,and shipping events,are beyond the scope of this guide.1.6 This guide does not address environmental challengingthat stimulates extreme climactic conditions that may exist inthe shipping and handling environment.Ref
7、er to PracticeD4332 for standard conditions that may be used to challengethe sterile barrier system to realistic extremes in temperatureand humidity conditions.See Terminology F1327 for a defini-tion of“environmental challenging.”1.7 This standard does not purport to address all of thesafety concern
8、s,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:2D4332 Practice for Conditioning Containers,Pac
9、kages,orPackaging Components for TestingE337 Test Method for Measuring Humidity with a Psy-chrometer(the Measurement of Wet-and Dry-Bulb Tem-peratures)F17 Terminology Relating to Flexible Barrier PackagingF1327 Terminology Relating to Barrier Materials for Medi-cal Packaging(Withdrawn 2007)3F2097 Gu
10、ide for Design and Evaluation of Primary FlexiblePackaging for Medical Products2.2 AAMI Standards:ANSI/AAMI/ISO 116071:2006,Packaging for TerminallySterilized Medical Devices4AAMI TIR 222007,Guidance forANSI/AAMI/ISO 11607,Packaging for Terminally Sterilized Medical Devices43.Terminology3.1 Definiti
11、onsFor general definitions of packaging formedical devices,seeANSI/AAMI/ISO 11607.For terminologyrelated to barrier materials for medical packaging see Termi-nology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 accelerated aging(AA),nstorage of samples at anelevated temperature(TAA)in
12、 order to simulate real time agingin a reduced amount of time.3.2.2 accelerated aging factor(AAF),nan estimated orcalculated ratio of the time to achieve the same level ofphysical property change as a sterile barrier system stored atreal time(RT)conditions.1This guide is under the jurisdiction of AS
13、TM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Aug.1,2011.Published November 2011.Originallyapproved in 1999.Last previous edition approved in 2007 as F1980 07.DOI:10.1520/F1980-07R11.2Fo
14、r 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.3The last approved version of this historical standard is referenced
15、onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.3 accelerated aging temperature(TAA),nthe elevated
16、temperature at which the aging study is conducted,and it maybe based on the estimated storage temperature,estimated usagetemperature,or both.3.2.4 accelerated aging time(AAT),nthe length of timethe accelerated aging is conducted.3.2.5 ambient temperature(TRT),nstorage temperaturefor real-time aging(RT)samples that represents storage con-ditions.3.2.6 sterile barrier system shelf life,nthe amount of realtime that a sterile barrier system can be expected to remain instorage at ambient conditions,o
