ASTM E2011 - 13

    Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand

    Active Standard ASTM E2011 | Developed by Subcommittee: E35.15

    Book of Standards Volume: 11.08

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    Significance 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 2Application 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 1A 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)

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E1482 Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

    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 (2007) Available from AOAC International, 481 North Frederick Ave., Suite 500, Gaithersburg, Maryland 20877-2417,

    ICS Code

    ICS Number Code 71.100.35 (Chemicals for industrial and domestic disinfection purposes); 71.100.70 (Cosmetics. Toiletries)

    UNSPSC Code

    UNSPSC Code 47131803(Household disinfectants)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/E2011-13

    Citation Format

    ASTM E2011-13, Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand, ASTM International, West Conshohocken, PA, 2013,

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