ASTM F2095-2007(2013) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates《有或无约束板的挠性包装件压力衰减泄漏试验的标标准试验方法》.pdf
《ASTM F2095-2007(2013) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates《有或无约束板的挠性包装件压力衰减泄漏试验的标标准试验方法》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2095-2007(2013) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates《有或无约束板的挠性包装件压力衰减泄漏试验的标标准试验方法》.pdf(6页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F2095 07 (Reapproved 2013)Standard Test Methods forPressure Decay Leak Test for Flexible Packages With andWithout Restraining Plates1This standard is issued under the fixed designation F2095; the number immediately following the designation indicates the year oforiginal adoption or, in
2、the case of revision, the year 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 These test methods cover the measurement of leaks innonporous film, foil, or laminat
3、e flexible pouches and foil-sealed trays, which may be empty or enclose solid product. Ifproduct is enclosed, seals or surfaces cannot be in contact withwater, oils, or other liquid.1.2 These test methods will detect leaks at a rate of1104sccs (standard cubic centimetres per second) or greater, infl
4、exible packages. The limitation of leak rate is dependent onpackage volume as tested.1.3 The following test methods are included:1.3.1 Test Method APressure Decay Leak Test for FlexiblePackages Without Restraining Plates1.3.2 Test Method BPressure Decay Leak Test for FlexiblePackages With Restrainin
5、g Plates1.4 These test methods are destructive in that they requireentry into the package to supply an internal pressure of gas,typically air or nitrogen, although other gases may be used.Theentry connection into the flexible package must be leak-tight.1.5 For porous packages, see 9.3.1.6 This stand
6、ard 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 AS
7、TM Standards:2D4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF17 Terminology Relating to F
8、lexible Barrier Packaging2.2 Other Document:ANSI/AAMI/ISO 116071:2006 Packaging for TerminallySterilized Medical DevicesPart 1: Requirements forMaterials, Sterile Barrier Systems, and Packaging Sys-tems33. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 integritythe unimpaired ph
9、ysical condition of thepackage. This implies that there are no leaks in the seals orbody materials.3.1.2 leakSee Terminology F17.3.1.3 nonporoustypes of materials that are not purposelydesigned to transfer gases through their matrix.3.1.4 restraining platesplates of rigid material, forexample, alumi
10、num, that are used to restrict the movement ofthe package during inflation.3.1.5 sealSee Terminology F17.3.1.6 standard cubic centimetre per second (sccs)the flowrate of a gas (air) at standard conditions of 20C (68F) and101.3 kPa (14.7 psig) (1 atmosphere or 760 mm Hg).3.1.6.1 DiscussionConditions
11、may be varied dependingon the source of data. Always check the definition being used.4. Summary of Test Method4.1 Detection of leak paths in flexible packages that havenonporous material surfaces and seals can be accomplished bypressurization of the package to a fixed pressure, shutting offthe press
12、ure and connecting a pressure transducer. Observedchanges in pressure indicate the presence of leakage paths inthe package seals or pinholes in the surfaces. This leak may berepresented in decay pressure units or calculated leak rateunits. To accomplish this technique, a leak-tight measuring1These t
13、est methods are under the jurisdiction of ASTM Committee F02 onFlexible Barrier Packaging and are the direct responsibility of Subcommittee F02.40on Package Integrity.Current edition approved Aug. 1, 2013. Published September 2013. Originallyapproved in 2001. Last previous edition approved in 2007 a
14、s F2095 07. DOI:10.1520/F2095-07R13.2For 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 American
15、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 States1path must be available between the package interior volumeand the pressure transduce
16、r (see Fig. 1).NOTE 1The coating used on porous barrier films will mask defects(pin-holes) in/through the porous material but not defects in the seals.4.2 Restraining plates may be used to limit the volume ofthe pressurized package. Because the sensitivity of these testmethods is dependent in part o
17、n the internal volume of thepackage, the effect of restraining plate use is to increase thesensitivity of the test (see Fig. 2). See Appendix X1 for furtherdiscussion of the effects of restraining plates on these testmethods.5. Significance and Use5.1 These test methods provide a rapid, simple to ap
18、plymethod to detect small leaks in flexible package seals or wallsat the leak rate level of greater than1104sccs, thusproviding a measure of package integrity. Porous barrier filmpackages made non-porous with an impermeable film formingcoating may demonstrate lateral leakage through the barriermater
19、ial. Verification of leakage differences from backgroundleakage must be included in validation methods. The use ofcalibrated hole sizes or orifices may be appropriate to deter-mine leakage sensitivity or barrier integrity for these materials.5.2 While theoretical leak rate sensitivity can be establi
20、shedby calculation, the test measurement is in pressure units and themeasuring instrument must be calibrated, certified, and verifiedwith these units.5.3 The pressure decay method of leak testing is a physicalmeasure of package integrity. When testing medical packagingwhich must conform to ISO 11607
21、1: 2006 standards, it maynecessary to verify the results of the pressure decay test methodwith other sterile package integrity test methods.5.4 Test Method A allows packages to be pressurizedwithout restraint. In Test Method A the pouch, tray, or othertype package will contain a volume of air define
22、d by itsmechanical configuration and its ability to resist internalpressure applied. This test method requires that the packagereach a stable volume configuration (stop stretching) to make ameasurement.5.5 Test Method B allows the use of rigid restraining platesagainst the walls of the package to li
23、mit its volume andstabilize the package volume.6. Apparatus6.1 Test Method A:6.1.1 A measuring instrument that provides the following:6.1.1.1 A means to detect pressure changes with sufficientsensitivity to achieve theoretical leak rates in the packagespecification;6.1.1.2 Automatic timer controls t
24、o pressurize the packageto a preset pressure, hold the pressure for a set time, andprovide a time period during which pressure change data canbe taken;6.1.1.3 A means to set pressure;6.1.1.4 A means of holding and displaying the pressurechange inside the package at the end of the test cycle;6.1.1.5
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