ASTM F 1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
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ASTM F 1608 Document Information:
Title
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
ASTM International
Publication Date:
Apr 10, 2000
Scope:
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.
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.
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 E 691)
should be conducted before this
test method would be condsidered adequate for purposes of setting
performance standards.
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.
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.
Keywords:
- biological barrier
- medical packaging
- microbial barrier
- microbial-challenge
- porous packaging
- sterile barrier
- sterile packaging
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