Work Item
ASTM WK89318

Withdrawal of E1327-07(2018) Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

Rationale

Rationale: I have reviewed this Method in detail and, in terms of FDA regulatory criteria, I find it irrelevant to registration of an antiseptic preparation to market. Therefore, I submit for Withdrawal. It is a Method quite expensive to execute and unlikely to be used out of curiosity. Further, it is redundant to ASTM E35.15 Method E 1174, Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations, which is the Method practiced to provide data to the FDA that are required for approval to market a healthcare hand antiseptic. This standard is being balloted for Withdrawal with no replacement.

Details

Developed by Subcommittee: E35.15

Committee: E35

Staff Manager: Brian Milewski

Work Item Status

Date Initiated: 01-20-2024

Technical Contact: John Mitchell