ASTM E3058 - 16

    Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations

    Active Standard ASTM E3058 | Developed by Subcommittee: E35.15

    Book of Standards Volume: 11.08

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    Significance and Use

    5.1 Many marketed hand antiseptics make claims of "long-lasting protection” or “extended kill” (for example 6 hours), which are typically based on results of testing as described in Test Method E1882 or Guide E2752, or both. At this time there are no standard methods for evaluating a hand antiseptic formulation for its ability to kill microorganisms on hands when a “dry” contamination event occurs at some time after product use. This test method provides a method to substantiate residual kill claims for hand antiseptics.

    1. Scope

    1.1 This test method is designed to determine the residual killing activity of skin antiseptics against transient microbial skin flora on the hands .2 It may be used to evaluate products that are used with the aid of water and rinsed off and those that are used without the aid of water and not rinsed off.

    1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56).

    1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2.

    1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5 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. For more specific precautionary statements see 8.1.

    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

    E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents

    E1882 Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique

    E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals

    E2752 Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products

    E2756 Terminology Relating to Antimicrobial and Antiviral Agents

    Federal Standards

    ICS Code

    ICS Number Code 11.080.20 (Disinfectants and antiseptics)

    UNSPSC Code

    UNSPSC Code 53131626(Hand sanitizer)

    Referencing This Standard
    Link Here
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    DOI: 10.1520/E3058-16

    Citation Format

    ASTM E3058-16, Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations, ASTM International, West Conshohocken, PA, 2016,

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