ASTM International - ASTM F1608-00(2004)

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

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Organization: ASTM International
Publication Date: 1 October 2004
Status: historical
Page Count: 9
ICS Code (Microbiology in general): 07.100.01
ICS Code (Packaging materials and accessories): 55.040
significance And Use:

The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this... View More

scope:

1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.

1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the LRV. Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.

1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be condsidered adequate for purposes of setting performance standards.

1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.

1.3 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

May 1, 2016
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test...
October 1, 2009
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test...
ASTM F1608-00(2004)
October 1, 2004
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test...
April 10, 2000
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test...
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