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1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.
1.2 These test methods will detect leaks at a rate of 1 104 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.
1.3 The following test methods are included:
1.3.1 Test Method A-- Pressure Decay Leak Test for Nonporous Flexible Packages Without Restraining Plates
1.3.2 Test Method B-- Pressure Decay Leak Test for Nonporous Flexible Packages With Restraining Plates
1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F17 Terminology Relating to Flexible Barrier Packaging
Other DocumentANSI/AAMI/ISO 11607–1:2006 Packaging for Terminally Sterilized Medical Devices--Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 19.060 (Mechanical testing); 55.040 (Packaging materials and accessories)
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ASTM F2095-01, Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates, ASTM International, West Conshohocken, PA, 2001, www.astm.orgBack to Top