【国外标准】 Standard Practice for Evaluation of First Aid Antiseptic Drug Products

5.1 The procedures in this practice should be used for in vivo evaluation of the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns.5.1.1 This practice is applicable for testing liquids, ointments, powders, films, or dressings, containing or impregnated with an antimicrobial agent, 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 practice 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, 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.