ASTM E2613-14
Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults

Standard No.

ASTM E2613-14

Release Date

2014

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E2613-23

Latest

ASTM E2613-23

Scope

5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate fungal contamination from experimentally-contaminated hands. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for viable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test.

5.2 Whereas this test method is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838) and vegetative bacteria (Test Method E2276).

5.3 Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (5). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid fungal removal by the drying process itself.

5.4 This test method is not designed to test surgical hand scrubs or preoperative skin preps.

5.5 The level of contamination with viable fungi on each fingerpad after the drying of the inoculum should be at least 10⁴ CFU so that it would permit the detection of up to a 4-log₁₀ reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.

1.1 This test method is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands (3) . This test method is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).

1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation.³

1.3 The test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 (4).

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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM E2613-14 Referenced Document

• ASTM D1129 Standard Terminology Relating to Water
• ASTM E1054 Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
• ASTM E1115 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations
• ASTM E1173 Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
• ASTM E1838 Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers
• ASTM E2197 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
• ASTM E2276 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• ASTM E2756 Standard Terminology Relating to Antimicrobial and Antiviral Agents

ASTM E2613-14 history

• 2023 ASTM E2613-23 Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• 2014 ASTM E2613-14 Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults
• 2008 ASTM E2613-08 Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults