1.1This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.
1.2This test method is applicable to porous materials used to package terminally sterilized medical devices.
1.3The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs.
1.4The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.