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Description of ASTM-E3321 2021ASTM E3321-21Active Standard: Standard Test Method for Intraluminal Catheter Model used to Evaluate Antimicrobial Urinary Catheters for Prevention of Escherichia coli Biofilm GrowthASTM E3321Scope 1.1 This test method specifies the operational parameters required to assess the ability of antimicrobial urinary catheters to prevent or control biofilm growth. Efficacy is reported as the log reduction in viable bacteria when compared to a repeatable (1)2 Escherichia coli biofilm grown in the intra-lumen of a urinary catheter under a constant flow of artificial urine. 1.2 The test method is versatile and may also be used for growing and/or characterizing biofilms and suspended bacteria of different species, although this will require changing the operational parameters to optimize the method based upon the growth requirements of the new organism. 1.3 This test method may be used to evaluate surface modified urinary catheters that contain no antimicrobial agent. 1.4 This test method describes how to sample and analyze catheter segments and effluent for viable cells. Biofilm population density is recorded as log colony forming units per surface area. Suspended bacterial population density is reported as log colony forming units per volume. 1.5 Basic microbiology training is required to perform this test method. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard 1.7 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. 1.8 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. Keywords antimicrobial surface; biofilm; Escherichia coli; Foley catheter; intraluminal catheter model; sampling; ICS Code ICS Number Code 07.100.01 (Microbiology in general) DOI: 10.1520/E3321-21 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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