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Description of ASTM-E2197 2024ASTM E2197-24Active Standard: Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of ChemicalsASTM E2197Scope 1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores (1-7) on disk carriers of brushed stainless steel that represent hard, nonporous environmental surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the number of viable organisms in the test inoculum should be sufficiently high to take into account both the performance standard and the experimental variations in the results. 1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing wipes. 1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (8). 1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). 1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and metric units follow. 1.6 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. 1.7 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 adenovirus; Aspergillus aculeatinus conidia; Bacillus spizizenii spores; bactericides; calicivirus; Candida albicans; cell cultures; chemical microbicides; Clostridium sporogenes spores; eluate; eluent; environmental surfaces; fungicides; hepatitis A virus; medical devices; membrane filtration; mycobactericides; Mycobacterium terrae; norovirus; parvovirus; Pseudomonas aeruginosa; quantitative carrier test; rhinovirus; rotavirus; soil load; sporicides; Staphylococcus aureus; standard hard water; surrogate; Trichophyton interdigitale conidia; virucides; viruses; ICS Code ICS Number Code 07.100.01 (Microbiology in general) DOI: 10.1520/E2197-24 The following editions for this book are also available...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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