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Significance and Use
The procedures in this test method should be used for in vivo evaluation the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns.
This test method is applicable for testing liquids, ointments, powders, films, or dressing containing or impregnated with an antimicrobial for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.
1.1 The tests described in this test method are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.
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. (See 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 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.
D1193 Specification for Reagent Water
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
UNSPSC Code 51100000(Anti infective drugs)