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ASTM F 2096 : 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

Superseded date

01-09-2020

Published date

10-04-2002

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Committee
F 02
DocumentType
Test Method
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 m with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.

1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.

1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure

1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.5

ASTM F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

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