ASTM F2638 - 18 - Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

ASTM F2638 - 18

Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

Status : Current   Published : September 2018

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1.1 This 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.

1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.

1.3 The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs.

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

1.5  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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6  This 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.




Standard NumberASTM F2638 - 18
TitleStandard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
StatusCurrent
Publication Date01 September 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Filtration efficiency, medical packaging, microbial barrier, microbial challenge, particulate barrier, porous packaging, sterile barrier, sterile packaging
ICS55.040
PublisherASTM
FormatA4
DeliveryYes
Pages17
File Size712 KB
Price£45.00


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