ASTM E1883-97

NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn. Contact ASTM International (www.astm.org) for the latest information.
Designation: E 1883 – 97
AMERICAN SOCIETY FOR TESTING AND MATERIALS
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Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Test Method for
Assessment of an Antibacterial Handwash Product by
1
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 3.1.6 transient microorganisms—microorganisms from the
environment that contaminate but do not normally permanently
1.1 This test method covers determining the effectiveness of
colonize skin.
an antibacterial handwash for reducing the level of aerobic
bacterial flora on the hands, following an extended period of
4. Summary of Test Method
use.
4.1 This hand degerming protocol is a modification of the
1.2 A knowledge of microbiological techniques is required
Cade Handwashing Procedure, that is a serial basin hand wash
for these procedures.
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sampling technique.
1.3 In this test method metric units are used for all applica-
4.1.1 Two baseline bacterial counts will be determined for
tions, except for distance. In this case, inches are used and
the hands and a post-usage count will be done after twelve days
metric units follow in parentheses.
of antibacterial handwash usage. The samples are collected
1.4 This standard does not purport to address all of the
from basin wash water following one or more 60 second
safety concerns, if any, associated with its use. It is the
washes with a bar soap that does not contain an antimicrobial.
responsibility of the user of this standard to establish appro-
At each sampling interval samples may be collected from the
priate safety and health practices and determine the applica-
first and or fifth hand wash in a series of five washes.
bility of regulatory limitations prior to use.
4.1.2 The data will be used to calculate the reduction of
bacterial flora resulting from the use of the antibacterial test
2. Referenced Documents
handwash product as described within the protocol. Reductions
2.1 ASTM Standards:
in bacterial populations calculated from baseline and post-
2
D 1193 Specification for Reagent Water
treatment samples collected after the first basin wash are
E 1054 Practices for Evaluating Inactivators of Antimicro-
reflective of the antimicrobial test soaps ability to reduce the
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or
3 population of transient flora on the hands. Reductions in
Preserved Products
bacterial populations calculated from baseline and post-
3. Terminology treatment samples collected after the fifth basin wash are
reflective of the antimicrobial test soaps ability to reduce the
3.1 Definitions:
population of resident flora on the hands.
3.1.1 active ingredient—a substance added to a formulation
specifically for inhibition or inactivation of microorganisms.
5. Significance and Use
3.1.2 active test formulation—a formulation with an active
5.1 This procedure should be used for in vivo evaluation of
ingredient.
the performance of antibacterial handwash products that are
3.1.3 control test formulation—a formulation without an
intended to reduce the skin micro flora following repeated use.
active in this test method. Frequently a bland soap.
Activity against the combined transient and resident micro
3.1.4 neutralization—inactivation of the antibacterial of the
flora may be assessed. Historically counts from the first basin
test material. This can be achieved through dilution of active
,
4 5
are considered to be transients . The latter measurement is
test formulations to levels too low to have an antibacterial
probably more meaningful as the resident population is more
activity, or through the use of chemical agents, called neutral-
stable.
izers, to eliminate antibacterial activity.
5.1.1 This test method is applicable for testing all forms of
3.1.5 resident microorganisms—microorganisms that live
topical antimicrobial handwash formulations.
and multiply on skin, forming a permanent population.
5.2 Performance of this procedure requires the knowledge
1
This test method is under the jurisdiction of ASTM Committee E-35 on 4
Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial
Soaps,” Journal of the Society of Cosmetic Chemistry, Vol. 2: 1951, pp 181–291.
Agents.
5
Roth, R.R., Williams, D.J., “Microbial Ecology of the Skin” Annual Review of
Current edition approved May 10, 1997. Published January 1998.
Microbiology, Vol. 42: 1988, pp. 441–64.
2
Annual Book of
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