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ASTM F 2638 : 2018

ASTM F 2638 : 2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

30-06-2022

Language(s)

English

Published date

11-10-2018

Publisher

American Society for Testing and Materials

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.

1.1This 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.

Committee
F 02
DocumentType
Test Method
Pages
17
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F 2097 : 2020 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM E 177 : 1990 : REV A : R1996 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 171/E171M : 2011 : R2020 Standard Practice for Conditioning and Testing Flexible Barrier Packaging
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

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Hardcopy - English
PDF - English
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