ASTM F2638-07
Historical Standard: ASTM F2638-07 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
SUPERSEDED (see Active link, below)
ASTM F2638
1. Scope
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 m particles and assessing the filtration efficiency of the material using either single or dual particle counters.
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636-3.
1.4 The values stated in SI units are to be regarded as the standard. The values given 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ISO Standard
ISO 56363 Paper and Board--Determination of Air Permeance (Medium Range)--Part 3: Bendtsen MethodKeywords
filtration efficiency; medical packaging; microbial barrier; microbial challenge; particulate barrier; porous packaging; sterile barrier; sterile packaging; Aerosol filtration; Microbial contamination; Performance; Porous packaging materials
ICS Code
ICS Number Code 55.040 (Packaging materials and accessories)
DOI: 10.1520/F2638-07
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