ASTM E1115-24 - Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

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 This method is quantitative. Limitations of this method are subjects who have not been in contact with antimicrobial products at least 7 days prior to the test and during the test and who have initial bacterial counts, ≥1 × 10⁵ CFU/per hand as determined by baseline measurements of the bacteria on their hands using the recovery techniques in this method.

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

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

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

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.