ASTM E2276-10
Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

Standard No.

ASTM E2276-10

Release Date

2010

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E2276-10(2019)

Latest

ASTM E2276-10(2019)

Scope

This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate selected types of bacteria from experimentally contaminated skin of the hands of adult subjects. 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 bacteria remaining after the inoculum has been allowed to dry (two), bacteria eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the bacteria-eliminating efficiency of the product under test. No more than 100 µL of the test bacterial suspension is required to complete one test. The results of testing with this test method may form the basis for confirmatory tests using a suitable whole-hand test protocol, such as Test Method E1174.

Whereas this test method relates to testing with bacteria, it can be readily adapted to work with protozoa and bacteriophages. Similar methods for work with fungi (Test Method E2613) and viruses of human origin (Test Method ) are already ASTM standards.

Potentially infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (7). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid bacterial removal by the drying process itself.

This test method is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).

The level of contamination with viable bacteria on each fingerpad after the drying of the inoculum should be five- to ten-fold higher than the product performance criterion required. For example, the titer in the dried inoculum on each fingerpad should be about 10⁵ colony forming units of the test bacterium when a >10⁴ reduction is required under the conditions of this test method.

1.1 This test method is designed to determine the activity of hygienic handwash and handrub (4) agents against transient bacterial flora on hands and is not meant for use with surgical hand scrubs or preoperative skin preps.

1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.

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 (5).

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 E2276-10 Referenced Document

• ASTM D1129 Standard Terminology Relating to Water
• 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 E1174 Standard Test Method for Evaluation of the Effectiveness of Healthcare Personnel Handwash Formulations
• ASTM E1838 Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers
• ASTM E2613 Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

ASTM E2276-10 history

• 2019 ASTM E2276-10(2019) Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• 2010 ASTM E2276-10 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• 2003 ASTM E2276-03e1 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects
• 2003 ASTM E2276-03 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects