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Significance and Use
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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1129 Terminology Relating to Water
E1115 Test Method for Evaluation of Surgical Hand Scrub Formulations
E1173 Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
E2613 Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults
ICS Number Code 71.100.70 (Cosmetics. Toiletries)
UNSPSC Code 47131803(Household disinfectants)