【国外标准】 Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling

5.1 Hand hygiene is important for preventing the spread of many types of infections.5.2 During routine activities, it is primarily the palmar surface, comprising palms, fingers, and finger pads, of the hands that may become contaminated with transient microorganisms. The contamination could then be transferred to articles touched or handled or to other parts of the body. Palmar contamination is used in Test Method E2784.5.3 In Test Method E1174, incomplete drying of the experimentally contaminated hands dilutes the applied test product, thus compromising its activity. Application of a smaller volume of the microbial test suspension keeps the soil load to a reasonable level while allowing the hands to become visibly dry prior to application of the test material and reference formulation. These modifications are aimed at producing a better approximation of in-use conditions and a more realistic assessment of the test substance, thus providing a more reliable indication of product performance.5.4 Unlike Test Methods E1174, E2755, and E2784, this practice enables a direct comparison between two formulations on the same subject. The practice also uses a mechanical scrubbing machine in conjunction with the glove juice technique for more efficient recovery of viable test bacteria from the palms. The mechanical sampling results in greater recovery of bacteria from the palms than conventional recovery methods, such as massaging.1.1 This practice covers and is designed to determine the relative effectiveness of antimicrobial handwashing agents in reducing transient microorganisms using a controlled handwash.1.2 Knowledge of microbiological techniques is required for these procedures.1.3 This practice is used to evaluate topical antimicrobial handwashing formulations.1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR Parts 50 and 56).1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 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. For more specific precautionary statements, see 8.1.1.7 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.