Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <emph type="bdit">ex vivo</emph> Porcine Skin
使用离体猪皮肤评估手部卫生局部抗菌产品有效性的标准指南
1.1
This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model.
1.2
Knowledge of microbiological techniques is required for these procedures.
1.3
This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.
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.
====== Significance And Use ======
5.1
The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling.
5.2
The techniques described can be used to simulate Test Method
E1174
and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes.
5.3
Use of the pigskin surrogate offers less expensive and higher throughput screening.