ASTM E1883-02

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Designation:E1883–02
Standard Test Method for
Assessment of an Antibacterial Handwash Product by
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Multiple Basin Wash Technique
This standard is issued under the fixed designation E 1883; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This test method covers determining the effectiveness of 3.1 Definitions:
an antibacterial handwash for reducing the level of aerobic 3.1.1 active ingredient—a substance performing a function
bacterial flora on the hands, following an extended period of definded by this method.
use. 3.1.2 active test formulation—a formulation with an active
1.2 A knowledge of microbiological techniques is required ingredient.
for these procedures. 3.1.3 control test formulation—a formulation without an
1.3 In this test method metric units are used for all applica- active in this test method. Frequently a bland soap.
tions, except for distance. In this case, inches are used and 3.1.4 neutralization—Aprocess that results in quenching or
metric units follow in parentheses. inactivation of the antimicrobial activity of a formulation. This
1.4 This standard does not purport to address all of the may be achieved with dilution of the formulation or with the
safety concerns, if any, associated with its use. It is the use of chemical agents, called neutralizers.
responsibility of the user of this standard to establish appro- 3.1.5 neutralizer —a procedure or chemical agent used to
priate safety and health practices and determine the applica- inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
bility of regulatory limitations prior to use. an antimicrobial agent.
1.5 Performance of this procedure requires the knowledge 3.1.6 resident microorganisms—microorganisms that live
of regulations pertaining to the protection of human subjects. and multiply on skin, forming a permanent population.
(Title 21 CFR, Part 50) 3.1.7 test formulation—a formulation containing an active
ingredient.
2. Referenced Documents
3.1.8 transient microorganisms—microorganisms that con-
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2.1 ASTM Standards: taminate but do not normally permanently colonize skin.
D 1193 Specification for Reagent Water
4. Summary of Test Method
E 1054 Practices for Evaluating Inactivators of Antimicro-
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or 4.1 This hand degerming protocol is a modification of the
Preserved Products Cade Handwashing Procedure, that is a serial basin hand wash
,
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2.2 Other Standard: sampling technique.
Title 21 Code of Federal Regulations (CFR), Part 50 Pro- 4.1.1 Two baseline bacterial counts will be determined for
tection of Human Subjects: Informed ConsentVerification thehandsandapost-usagecountwillbedoneaftertwelvedays
& Part 56, Institutional Review Boards. Available from of antibacterial handwash usage. The samples are collected
U.S. Government Printing Office, Superintendent of from basin wash water following one or more 60 second
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Documents, Washington, DC 20402. washes with a bar soap that does not contain an antimicrobial.
At each sampling interval samples may be collected from the
first and or fifth hand wash in a series of five washes.
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This test method is under the jurisdiction of ASTM Committee E35 on
4.1.2 The data will be used to calculate the reduction of
Pesticides and is the direct responsibility of Subcommittee E35.15 onAntimicrobial
bacterial flora resulting from the use of the antibacterial test
Agents.
Current edition approved Oct. 10, 2002. Published January 2003. Originally
approved in 1997. Last previous edition approved in 1997 as E1883–97.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene
Standards volume information, refer to the standard’s Document Summary page on Soaps,” Journal of the Society of Cosmetic Chemistry, Vol. 2: 1951, pp 181–291.
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the ASTM website. Price, P.B., “The bacteriology of normal skin: a new quantitative test applied to
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Available from U.S. Government Printing Office, Superintendent of Docu- a study of the bacterial flora and disinfectant action of mechanical cleansing,”
ments, Washington D.C. Journal Infection Control, Vol. 63:1938, pp 301–318.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E1883–02
handwashproductasdescribedwithintheprotocol.Reductions 7.6 Bland cleansing formulation, a mild, non-antimicrobial
in bacteria
...