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Description of ASTM-E2011 2013ASTM E2011 - 13Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire HandActive Standard ASTM E2011 | Developed by Subcommittee: E35.15 Book of Standards Volume: 11.05 ASTM E2011Significance and Use 5.1 This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and also enables alternative product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E1838 , which gives precise reductions in viral infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E1838 . 5.2 This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.
Note 2 Application of viruses on the entire surface of both hands entails a greater risk to the subjects than
using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened
for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.
1. Scope 1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce or eliminate viable viruses from the skin of human hands.
Note 1 A knowledge of virological techniques is required for this test method.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard may involve hazardous materials, operations and equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use. The user should consult a reference for laboratory safety recommendations. ( 3- 5 )
ASTM Standards E1482 Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults AOAC Standard AOAC 960.9 Official Methods of Analysis (1990) Available from AOAC International, 481 North Frederick Ave., Suite 500, Gaithersburg, Maryland 20877-2417, http://www.aoac.org.Keywords adenovirus; antisepsis; antiseptics; calicivirus; handrubbing; handwashing; in vivo ; norovirus; rhinovirus; rotavirus; skin sampling; viral infection; virucidal activity; virus-eliminating activity; ICS Code ICS Number Code 11.080.20 (Disinfectants and antiseptics) DOI: 10.1520/E2011-13 ASTM International is a member of CrossRef. ASTM E2011The 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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