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Significance and Use
The procedure is used to evaluate personal cleansing products containing antibacterial ingredients that are intended to reduce the number of organisms on intact skin. It also may be used to demonstrate the effect of residual antibacterial activity by means of inhibition of the proliferation of bacteria on the skin after contact.
1.1 This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing product in reducing the numbers of a marker organism (representing transients) both immediately and after prolonged exposure to (cleansing) washing when used as recommended under simulated use conditions. The method demonstrates the effect of residual antibacterial activity by means of inhibition of proliferation of bacteria on the skin after the contact period. Antimicrobial activity is compared with a vehicle or to a baseline organism count.
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.
1.5 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
E1874 Test Method for Recovery of Microorganisms From Skin using the Cup Scrub Technique
Federal Document21CFRParts50and56 Code of Federal Regulations: Protection of Human Subjects; Institutional Review Boards
ICS Number Code 11.080.20 (Disinfectants and antiseptics); 71.100.35 (Chemicals for industrial and domestic desinfection purposes)
UNSPSC Code 47131803(Household disinfectants)