I have reviewed this Method in detail and, in terms of FDA regulatory criteria, find it is irrelevant to registration of an antimicrobial preparation to market. It is a Method expensive to execute and is unlikely to be used out of curiosity. Further, it is redundant to ASTM E35.15 Method E1174, Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations, which is the Method practiced to provide the data that are required by the FDA for approval to market a health care hand antiseptic .
Date Initiated: 11-20-2023
Technical Contact: John Mitchell