ASTM E2011-09
(Test Method)Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand
Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand
SIGNIFICANCE AND USE
This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and also enables alternate product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E 1838, which gives precise reductions in virus infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E 1838.
This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.
Note 2—Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.
SCOPE
1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce viral contamination from hands.
Note 1—A knowledge of virological techniques is required for this test method.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard may involve hazardous materials, operations and equipment. 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. The user should consult a reference for laboratory safety recommendations. (3-5)
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Designation: E2011 − 09
StandardTest Method for
Evaluation of Hygienic Handwash and Handrub
Formulations for Virus-Eliminating Activity Using the Entire
1
Hand
This standard is issued under the fixed designation E2011; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Mechanicalremovaland/orinsituinactivationofvirusesbyhygienichandwashandhandrubagents
can be assessed using artificially-contaminated hands of adults. This test method uses the entire
surface of both hands in contrast to only the fingerpads in the procedure described in Test Method
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E1838. However, the reported results from these two methods are comparable. (1, 2)
1. Scope E1838Test Method for Determining the Virus-Eliminating
EffectivenessofHygienicHandwashandHandrubAgents
1.1 This test method is designed to evaluate handwash or
Using the Fingerpads of Adults
handrub agents for their ability to reduce viral contamination
2.2 AOAC Standard:
from hands.
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AOAC 960.9 Official Methods of Analysis (1990)
NOTE1—Aknowledgeofvirologicaltechniquesisrequiredforthistest
method.
3. Terminology
1.2 The values stated in SI units are to be regarded as
3.1 Definitions of Terms Specific to This Standard:
standard. No other units of measurement are included in this
3.1.1 hygienic (health-care personnel) handwash agents,
standard.
n—agents generally used for handwashing by personnel in
1.3 This standard may involve hazardous materials, opera-
hospitals, other health-care facilities, day-care centers, nursing
tions and equipment. This standard does not purport to address
homes, and food-handling establishments; should be safe for
all of the safety concerns, if any, associated with its use. It is
repeated use, non-irritating, fast-acting, and efficient in elimi-
the responsibility of the user of this standard to establish
nating transient microorganisms from intact skin.
appropriate safety and health practices and determine the
3.1.2 hygienic handrub agents (that is, hand sanitizers),
applicability of regulatory limitations prior to use. The user
n—agents generally used for hand hygiene by personnel in
should consult a reference for laboratory safety recommenda-
hospitals, other health-care facilities, day-care centers, nursing
tions. (3-5)
homes, and food-handling establishments that do not require
rinsing; should be safe for repeated use, non-irritating, fast-
2. Referenced Documents
acting, and efficient in eliminating transient microorganisms
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2.1 ASTM Standards:
from intact skin.
E1482TestMethodforNeutralizationofVirucidalAgentsin
3.1.3 non-medicated soap, n—a soap or detergent that is
Virucidal Efficacy Evaluations
mildtotheskinanddoesnotcontainanygermicidalchemicals.
3.1.4 soil (organic) load, n—a solution of one or more
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This test method is under the jurisdiction of ASTM Committee E35 on organicand/orinorganicsubstancesaddedtothesuspensionof
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
the test organism to simulate the presence of body secretions,
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
excretions or other extraneous substances.
Current edition approved April 1, 2009. Published April 2009. Originally
approvedin1999.Lastpreviouseditionapprovedin1999asE2011–99,whichwas
3.1.5 virus-eliminating (killing/removing) agent, n—any
withdrawn in August 2008 and reinstated in April 2009. DOI: 10.1520/E2011-09.
agent that rids hands of viruses by either killing them on the
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The boldface numbers in parentheses refer to a list of references at the end of
skin or by dislodging them for subsequent wash-off.
this test method.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on Available from AOAC International, 481 North Frederick Ave., Suite 500,
the ASTM website. Gaithersburg, Maryland 20877-2417, http://www.aoac.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2011 − 09
3.1.6 virus inactivating agent, n—any agent that renders a in the field. This test method incorporates whole-hand expo-
virus noninfectious. sure and reflects actual use conditions such as friction during
hand decontamination, and also enables alternate product
4. Summary of Test Method
forms such as alcohol- or non-alcohol-based liquids, gels, and
foams to be tested according to label directions. It is meant to
4.1 This test metho
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