ASTM-F2096 2004

$40.63

F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

Published By	Publication Date	Number of Pages
ASTM	2004	5

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Category: ASTM

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Description

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 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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology Summary of Test Method Significance and Use
2	Apparatus Sampling Conditioning Procedure FIG. 1
3	Report Precision and Bias Keywords TABLE 1
4	A1. ESTABLISHMENT OF TEST PRESSURE A1.1 FIG. 2

Additional information

Standard Title	F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
Published Code	ASTM
Publication Date	2004
Pages Count	5

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ASTM-F2096 2004

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