ASTM E2276-03

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Designation:E2276–03
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
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Fingerpads of Adult Subjects
This standard is issued under the fixed designation E 2276; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
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Hands can spread many types of pathogens directly (1) or by transfer of such organisms to other
surfaces and objects during casual contact (2,3). Therefore, regular and proper decontamination of
hands by caregivers and food-handlers in particular is crucial for infection control. Hygienic hand
antisepsis is meant to reduce the load of transient microflora on hands, thereby reducing the risk of
disease transmission. Such reduction in the bacterial load may be due to a combination of bacterial
inactivation and removal of viable bacteria from the skin. In this method the test bacterial suspension
is placed on the thumb- and fingerpads of adults to simulate the contamination of hands with transient
microflora, the inoculum on the fingerpads is allowed to dry and is then treated with test and control
solutions. Since in each test all ten digits on any given subject can be used, the protocol permits the
inclusion of the required controls and several replicates of the test formulation in the same sitting.
1. Scope E 1115 Test Method for Evaluation of Surgical Hand Scrub
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Formulation
1.1 This test method is designed to determine the activity of
E 1173 Test Method for Evaluation of a Pre-Operative Skin
hygienic handwash and handrub (4) agents against transient
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Preparation
bacterial flora on hands and is not meant for use with surgical
E 1174 Test Method for Evaluation of Health Care Person-
hand scrubs or preoperative skin preps.
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nel Handwash Formulation
1.2 Performance of this procedure requires the knowledge
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E 1838 Test Method for Determining the Virus-Eliminating
of regulations pertaining to the protection of human subjects.
Effectiveness of Liquid Hygienic Handwash and Handrub
1.3 The test method should be performed by persons with
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Agents Using the Fingerpads of Adult Volunteers
training in microbiology in facilities designed and equipped for
work with infectious agents at biosafety level 2 (5).
3. Terminology
1.4 This standard does not purport to address all of the
3.1 Definitiions—For definitions of general terms used in
safety concerns, if any, associated with its use. It is the
this test method, refer to Terminology D 1129.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.2.1 active ingredient, n—a substance added to a formula-
bility of regulatory limitations prior to use.
tion specifically for the inhibition or inactivation of microor-
2. Referenced Documents ganisms.
3.2.2 handrub agent, n—a liquid or gel which is applied by
2.1 ASTM Standards:
4 rubbing to decontaminate lightly soiled hands between hand-
D 1129 Terminology Relating to Water
washings; such agents normally contain alcohol alone or with
other active ingredients.
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This test method is under the jurisdiction of ASTM Committee E35 on
3.2.3 hard water, n—water with a standard hardness of 200
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antibacterial
ppm as calcium carbonate.
Agents.
3.2.4 hygienic handwash agent, n—an agent generally used
Current edition approved May 10, 2003. Published July 2003.
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for handwashing by personnel in hospitals, other health-care
The boldface numbers in parentheses refer to the list of references at the end of
this standard.
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Federal Register, Vol 46, No. 17, Jan. 27, 1991.
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Annual Book of ASTM Standards, Vol 11.04. Annual Book of ASTM Standards, Vol 11.05.
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E2276–03
facilities, day-care centers, nursing homes, and food-handling reference solution (two), and up to four replicates to assess the
establishments should be safe for repeated use, nonirritating, bacteria-eliminating efficiency of the product under test. No
fast-acting, and efficient in eliminating transient microorgan- more than 100 µLof the test bacterial suspension is required to
isms from intact skin. complete one test. The results of testing with this test method
3.2.5 neutralization, n—a process which results in quench- may form the basis for confirmatory tests using a suitable
ing the antimicrobial activity of a test
...