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ASTM F2228

Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method

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Organization: ASTM
Publication Date: 10 December 2002
Status: inactive
Page Count: 5
ICS Code (Medical sciences and health care facilities in general): 11.020
ICS Code (Non-destructive testing): 19.100
scope:

This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 µm (0.004 in.) diameter in the seal as well as 50 µm (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.

NOTE 1 - This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.

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

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.

Document History

August 1, 2013
Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
This non-destructive test method detects leaks in nonporous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as...
ASTM F2228
December 10, 2002
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as...
December 10, 2002
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
This non-destructive test method detects leaks in nonporous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as...
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