ASTM E1838-10
(Test Method)Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
SIGNIFICANCE AND USE
This in vivo procedure is designed to test the ability of hygienic handwash and handrub agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adults. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of input virus control (two), virus remaining viable after the inoculum has been allowed to dry (two), virus eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the virus-eliminating efficiency of the substance under test. No more than 100 μL of the virus suspension are required to complete one test. The results of testing with this test method may form the basis for further tests using a suitable whole-hand test protocol (for example, Test Method E2011).
This test method is designed to be performed by a trained individual, who is responsible for choosing the appropriate host system for the test virus and applying the techniques necessary for propagation and maintenance of host and test virus. For a reference text, refer to Lennette et al (8).
Whereas the method described here relates to testing with viruses of human origin, it can be readily adapted to work with animal pathogenic viruses as well as bacteriophages. Standard methods for working with bacteria (Test Method E2276) and fungi (Test Method E2613) are also available.
Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (9). A step for the drying of fingerpads after exposure to the control or test substance, therefore, has not been included to avoid virus removal by the drying process itself.
This test method is not meant for use with surgical hand scrubs or preoperative skin preps.
The level of viable virus on each fingerpad after the drying of the inoculum should not be less than 104 infectious units which would permit the detection of up to a 4 log10 reduct...
SCOPE
1.1 Human skin is not known to carry viruses as a part of its resident microbiota. Hands transiently contaminated with viruses can, however, act as vehicles for the spread of many types of viral infections. Hand hygiene is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reductions in the virus load may be due to a combination of virus inactivation and mechanical removal of infectious virus from the skin.
1.2 This test method is designed to determine the comparative virus-eliminating effectiveness of microbicidal or non-microbicidal formulations. This test method is not meant for use with surgical hand scrubs or preoperative skin preps.
Note 1—The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2 (6).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
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Designation: E1838 − 10
Standard Test Method for
Determining the Virus-Eliminating Effectiveness of Hygienic
Handwash and Handrub Agents Using the Fingerpads of
1
Adults
This standard is issued under the fixed designation E1838; 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
Handsplayanimportantroleinthespreadofmanyviruses.Thus,properandregularhandhygiene
is crucial in preventing such spread, particularly in health-care settings, day-care centers, and
food-handlingestablishments.Manyvirusesthatareknowntospreadthroughcontaminatedhandscan
remain infectious for several hours on human hands, and also may be more resistant than the bacteria
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commonly used to evaluate the microbicidal activity of handwash and handrub agents (1, 2, 3, 4).
Contaminated hands also can readily transfer infectious virus to other surfaces (1, 2, 3). Hand
antisepsis has been shown to interrupt the spread of viral infections (5). Standardized methods to
assessthevirus-eliminatingpotentialofhandwashandhandrubagentshavenotbeenavailableandthis
test method addresses the gap.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 Humanskinisnotknowntocarryvirusesasapartofits
bility of regulatory limitations prior to use.
resident microbiota. Hands transiently contaminated with vi-
rusescan,however,actasvehiclesforthespreadofmanytypes
2. Referenced Documents
ofviralinfections.Handhygieneismeanttoreducetheloadof
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2.1 ASTM Standards:
viruses and other transient microorganisms on hands, thereby
E2011Test Method for Evaluation of Hygienic Handwash
reducing the risk of disease transmission. Such reductions in
and Handrub Formulations for Virus-EliminatingActivity
the virus load may be due to a combination of virus inactiva-
Using the Entire Hand
tion and mechanical removal of infectious virus from the skin.
E2276 Test Method for Determining the Bacteria-
1.2 This test method is designed to determine the compara-
Eliminating Effectiveness of Hygienic Handwash and
tive virus-eliminating effectiveness of microbicidal or non-
Handrub Agents Using the Fingerpads of Adults
microbicidal formulations. This test method is not meant for
E2613Test Method for Determining Fungus-Eliminating
use with surgical hand scrubs or preoperative skin preps.
EffectivenessofHygienicHandwashandHandrubAgents
NOTE1—Thetestmethodshouldbeperformedbypersonswithtraining
Using Fingerpads of Adults
in virology in facilities designed and equipped for work with infectious
agents at biosafety level 2 (6).
3. Terminology
1.3 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
1.4 This standard does not purport to address all of the
hospitals, other health-care facilities, day-care centers, nursing
safety concerns, if any, associated with its use. It is the
homes, and food-handling establishments should be safe for
repeated use, nonirritating, fast-acting, and efficient in elimi-
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This test method is under the jurisdiction of ASTM Committee E35 on
nating transient microorganisms from intact skin.
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2010. Published May 2010. Originally
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approved in 1996. Last previous edition approved in 2002 as E1838–02. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E1838-10. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1838 − 10
3.1.2 nonmedicated soap, n—asoapordetergentthatismild 5.3 Whereas the method described here relates to testing
to the skin and does not contain any germicidal chemicals. withvirusesofhumanorigin,itcanbereadilyadaptedtowork
with animal pathogenic viruses as well as bacteriophages.
3.1.3 soil(organic) load, n—a solution of one or more
Standard methods for working with bacteria (Test Method
organicand/orinorganicsubstancesaddedtothesuspensionof
E2276) and fu
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E1838–02 Designation:E1838–10
Standard Test Method for
Determining the Virus-Eliminating Effectiveness of Liquid
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adult VolunteersAdults
This standard is issued under the fixed designation E1838; 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
Hands play an important role in the spread of many viruses, thusviruses. Thus, proper and regular
handwashinghandhygieneisconsideredcrucialinpreventingsuchspread,particularlyinhealth-care
settings, day-care centers, and food-handling establishments. Many viruses that are known to spread
through contaminated hands can remain infectious for several hours on human hands, and also may
be more resistant than the bacteria commonly used to evaluate the germicidalmicrobicidal activity of
2
handwash and handrub agents (1,2, 3, 4). Contaminated hands also can readily transfer infectious
virus to other surfaces (1,2, 3). Hand antisepsis has been shown to interrupt the spread of viral
infections (45). Standardized methods to assess the virus-eliminating potential of handwash and
handrub agents have not been available and this test method addresses the gap.
1. Scope
1.1 Humanskindoesisnotknowntocarryvirusesasapartofitsresidentflora.microbiota.Handstransientlycontaminatedwith
viruses can, however, can act as vehicles for the spread of many types of viral infections. Hygienic hand washing Hand hygiene
is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease
transmission. Such reductions in the virus load may be due to a combination of virus inactivation and mechanical removal of
infectious virus from the skin.
1.2Standard1.2 This test methods to assess the capacity of hygienic handwash and handrub agents to reduce virus levels on
hands are not presently available. This test method, therefore, has been method is designed to determine the comparative
virus-eliminatingeffectivenessofgermicidalmicrobicidalornon-germicidalnon-microbicidalformulations.Thistestmethodisnot
meant for use with surgical hand scrubs or preoperative skin preps.
NOTE 1—Thetestmethodshouldbeperformedbypersonswithtraininginvirologyinfacilitiesdesignedandequippedforworkwithinfectiousagents
at biosafety level 2 (56).
1.3
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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
2.1 ASTM Standards:
D1129Terminology Relating to Water
E1115Test Method for Evaluation of Surgical Hand Scrub Formulations
E1173Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
E1174Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
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ThistestmethodisunderthejurisdictionofASTMCommitteeE35onPesticidesandAlternativeControlAgentsandisthedirectresponsibilityofSubcommitteeE35.15
on Antibacterial Agents.
Current edition approved April 10, 2002. Published July 2002. Originally published as E1838–96. Last previous edition E1838–96. DOI: 10.1520/E1838-02.on
Antimicrobial Agents.
CurrenteditionapprovedApril1,2010.PublishedMay2010.Originallyapprovedin1996.Lastpreviouseditionapprovedin2002asE1838–02.DOI:10.1520/E1838-10.
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The boldface numbers in parentheses refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E1838–10
E2011Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-EliminatingActivity Using the
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Entire Hand ASTM Standards:
E2011 TestMethodforEvaluationofHygienicHandwashandHandrubFormulationsforVirus-EliminatingActivityUsingthe
Entire Hand
E2276 TestMethodforDeterminingtheBacteria-EliminatingEffectivenessofHygienicHandwashandHandrubAgentsUsing
the Fingerpads of Adults
E2613 Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic
...
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