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  • ASTM
    E2111-12(2018) Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemicals
    Edition: 2018
    $78.62
    Unlimited Users per year

Description of ASTM-E2111 2018

ASTM E2111-12-Reapproved2018

Active Standard: Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemicals




ASTM E2111

Scope

1.1 This test method is designed for use in product development and for the generation of product potency data. This test method permits the loading of each carrier with a known volume of the test organism. The incorporation of controls can also determine the initial load of colony forming units (CFU) of organisms on the test carriers and any loss in CFU after the mandatory drying of the inoculum.

1.2 This test method is designed to have survivors and also to be used with a performance standard. The surviving microorganisms on each test carrier are compared to the mean of no less than three control carriers to determine if the performance standard has been met. To allow proper statistical evaluation of results, the size of the test inoculum should be sufficiently large to take into account both the performance standard and the experimental variation in the results. For example, if an arbitrary performance standard of 6-log10 reduction in the viability titer of the test organism is used, and an inoculum size of 107 CFU, then theoretically a maximum of ten survivors per carrier is permitted; however, because of experimental variability, the exact target may need to be higher than 106 CFU/carrier, thus fewer survivors would be permitted.

1.3 This test method should be performed by persons with training in microbiology and in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (3).

1.4 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow.

1.5 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).

1.6 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

Bacillus subtilis spores; bactericides; chemical microbicides; Clostridium sporogenes spores; eluate; eluent; environmental surfaces; fungicides; germicides; log10 reductions; medical devices; membrane filtration; mycobactericides; Mycobacterium terrae; Pseudomonas aeruginosa; quantitative carrier test; soil load; sporicides; Staphylococcus aureus; standard hard water; surrogate; Trichophyton mentagrophytes conidia;


ICS Code

ICS Number Code 71.040.50 (Physicochemical methods of analysis)


DOI: 10.1520/E2111-12R18

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About ASTM

ASTM 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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