【国外标准】 Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

5.1 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of microorganisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, maintenance of some degree of reduction for an extended time.1.1 The practice is designed to measure the reduction of the microflora of the skin.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3.1 Exception—In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses.1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2NOTE 1: Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations.1.5 This standard does not purport to address all of the safety problems, 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.