Potřebujeme váš souhlas k využití jednotlivých dat, aby se vám mimo jiné mohly ukazovat informace týkající se vašich zájmů. Souhlas udělíte kliknutím na tlačítko „OK“.
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
Automaticky přeložený název:
Standardní zkušební metody pro poklesu tlaku zkouška těsnosti pro flexibilní obaly sa bez ŽIVOLOVNÝCH desky
NORMA vydána dne 1.8.2013
Označení normy: ASTM F2095-07(2013)
Poznámka: NEPLATNÁ
Datum vydání normy: 1.8.2013
Kód zboží: NS-52798
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
flexible packaging, leak test, medical packaging, pressure decay testing, restraining plate test, ISO-11607, ICS Number Code 19.060 (Mechanical testing),55.040 (Packaging materials and accessories)
Significance and Use | ||||||||||
5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials. 5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units. 5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods. 5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement. 5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume. |
||||||||||
1. Scope | ||||||||||
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 × 10−4 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 Flexible Packages Without Restraining Plates 1.3.2 Test Method B—Pressure Decay Leak Test for 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 For porous packages, see 1.6 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 | ||||||||||
|
Historická
1.8.2008
Historická
1.12.2010
Historická
1.12.2009
Historická
1.5.2014
Historická
1.1.2010
Historická
1.5.2014
Chcete pravidelně odebírat informace o nově vycházejících normách z celého světa a to zcela zdarma?
Přihlašte se k odběru. Vše je velice jednoduché a absolutně ZDARMA.
Na výběr máte vydavatele z celého světa.
Poslední aktualizace: 29.11.2024 (Počet položek: 2 209 895)
© Copyright 2024 NORMSERVIS s.r.o.