Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using ex vivo Porcine Skin
Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using ex vivo Porcine Skin
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. SCOPE 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.
ASTM E2897-22 is a standard guide developed by ASTM International for evaluating the effectiveness of hand hygiene topical antimicrobial products using ex vivo porcine (pig) skin. This guide provides a reliable, practical, and safe alternative to human skin testing, leveraging pigskin as a surrogate model to assess antimicrobial efficacy. The standard details procedures using the cup scrub technique for sampling and is especially valuable for evaluating both handwash and handrub formulations. This approach addresses ethical and safety concerns by avoiding the exposure of human subjects to potentially pathogenic microorganisms and offers cost-effective, higher-throughput screening options for manufacturers and quality control laboratories.
The ASTM E2897-22 standard is widely used in the following contexts:
Другие стандарты ASTM
Several ASTM standards complement and inform practices described in ASTM E2897-22:
Adopting ASTM E2897-22 enables:
Keywords: hand hygiene, antimicrobial efficacy, pigskin model, cup scrub technique, handwash formulations, handrub testing, ASTM standards, surrogate model, quality assurance in antimicrobials