Active Standard ASTM E2613 | Developed by Subcommittee: E35.15
Book of Standards Volume: 11.05
Significance and Use
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 been allowed to dry (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.
Whereas this test method is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E 1838
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.
This test method is not meant for testing surgical hand scrubs or preoperative skin preps.
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 E 1115
1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation.
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.
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
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
E1115 Test Method for Evaluation of Surgical Hand Scrub Formulations
E1173 Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
E2276 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
ICS Number Code 71.100.70 (Cosmetics. Toiletries)