Rationale

This test method is designed to evaluate antimicrobial agents in formulations for utility and effectiveness for virus-eliminating activity using human subjects.

Formerly under the jurisdiction of Committee E35 on Pesticides and Alternative Control Agents, this test method was withdrawn in August 2008 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

This test method should be used to evaluate the virus-eliminating effectiveness of these formulations after handwashing. Effective formulations can be further evaluated in a clinical trial on human subjects. Published data have shown (1) that results of in vitro tests do not accurately reflect what occurs when this class of products is used in the health care facility. This test method involves the incorporation of whole hand exposure and friction from washing, reflecting actual use conditions in human subjects. It is meant to confirm the results of testing with Test Method E 1836. This method gives precise reductions on a limited area of the finger, the fingerpads.

This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.

1.1 This test method is designed to evaluate antimicrobial agents in formulations for utility and effectiveness for virus-eliminating activity using human subjects.

1.2 This standard may involve hazardous materials, operations and equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use. The user should consult a reference for laboratory safety recommendations. (2, 3)