Standard Active Last Updated: Dec 04, 2017
ASTM E1115-11(2017)

Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

Significance and Use

5.1 The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.

Scope

1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.

1.2 A knowledge of microbiological techniques is required for these procedures.

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

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

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

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 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.

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Details
Book of Standards Volume: 11.08
Developed by Subcommittee: E35.15
Pages: 6
DOI: 10.1520/E1115-11R17
ICS Code: 11.080.20; 71.100.35