【国外标准】 Standard Practice for Recovery of Microorganisms From Skin using the Cup Scrub Technique

5.1 The procedure can be incorporated into protocols used to evaluate test materials containing antibacterial ingredients that are intended to reduce significantly the number of organisms on intact skin. It also may be used to provide an indication of residual antibacterial activity (as in Guide E2752). Examples of test materials, for which this practice is applicable, include pre-operative skin preparations, hand-washes, surgical scrubs, acne reduction products, and others. For each type of test material, types of resident flora or surrogate organisms, or a combination thereof, may differ and should be considered (this is, aerobic bacteria, anaerobic bacteria, yeast, or mold).5.2 The procedure may be used in protocols intended to evaluate and identify resident flora from the skin.5.3 Performance of this technique may require the knowledge of regulations pertaining to the protection of human subjects if the protocol involves application of the technique to the skin of human subjects.1.1 This practice is designed to recover microorganisms from the skin of human subjects or human subject surrogates (animal skin, isolated porcine skin, human skin equivalents, and other such surfaces).1.2 Knowledge of microbiological techniques is required for these procedures.1.3 It is the responsibility of the investigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) is required.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.