ASTM E1838-02
(Test Method)Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers
Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers
SIGNIFICANCE AND USE
This in vivo procedure is designed to test the ability of hygienic handwash agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adult volunteers. 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), amount of virus remaining 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 product 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 confirmatory tests using a suitable whole-hand test protocol.
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 Schmidt and Emmons (7).
Whereas, this test method relates to testing with viruses of human origin, it can be readily adapted to work with bacteria, fungi, protozoa and bacteriophages.
Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (8). A step for the drying of fingerpads after exposure to the control or test solution, 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 amount of virus on each fingerpad after the drying of the inoculum should not be less than 104 infectious units that would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by a given product under the conditions of this test method.
SCOPE
1.1 Human skin does not carry viruses as a part of its resident flora. Hands transiently contaminated with viruses, however, can act as vehicles for the spread of many types of viral infections. Hygienic hand washing is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reduction in the virus load may be due to a combination of virus inactivation and removal of infectious virus from the skin.
1.2 Standard 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 designed to determine the comparative virus-eliminating effectiveness of germicidal or non-germicidal 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 (5).
1.3 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.
General Information
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Standards Content (Sample)
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Designation:E1838–02
Standard Test Method for
Determining the Virus-Eliminating Effectiveness of Liquid
Hygienic Handwash and Handrub Agents Using the
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Fingerpads of Adult Volunteers
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, thus proper and regular handwashing
is considered crucial in preventing such spread, particularly in health-care settings, day-care centers,
andfood-handlingestablishments.Manyvirusesthatareknowntospreadthroughcontaminatedhands
can remain infectious for several hours on human hands, and also may be more resistant than the
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bacteriacommonlyusedtoevaluatethegermicidalactivityofhandwashandhandrubagents (1,2, 3).
Contaminated hands also can readily transfer infectious virus to other surfaces (1,2). Hand antisepsis
has been shown to interrupt the spread of viral infections (4). 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 responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 Human skin does not carry viruses as a part of its
bility of regulatory limitations prior to use.
resident flora. Hands transiently contaminated with viruses,
however, can act as vehicles for the spread of many types of
2. Referenced Documents
viral infections. Hygienic hand washing is meant to reduce the
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2.1 ASTM Standards:
load of viruses and other transient microorganisms on hands,
D1129 Terminology Relating to Water
thereby reducing the risk of disease transmission. Such reduc-
E1115 Test Method for Evaluation of Surgical Hand Scrub
tion in the virus load may be due to a combination of virus
Formulations
inactivation and removal of infectious virus from the skin.
E1173 TestMethodforEvaluationofPreoperative,Precath-
1.2 Standard test methods to assess the capacity of hygienic
eterization, or Preinjection Skin Preparations
handwash and handrub agents to reduce virus levels on hands
E1174 Test Method for Evaluation of the Effectiveness of
are not presently available. This test method, therefore, has
Health Care Personnel Handwash Formulations
been designed to determine the comparative virus-eliminating
E2011 Test Method for Evaluation of Hygienic Handwash
effectiveness of germicidal or non-germicidal formulations.
and Handrub Formulations for Virus-Eliminating Activity
Thistestmethodisnotmeantforusewithsurgicalhandscrubs
Using the Entire Hand
or preoperative skin preps.
NOTE 1—Thetestmethodshouldbeperformedbypersonswithtraining 3. Terminology
in virology in facilities designed and equipped for work with infectious
3.1 Definitions—For definitions of general terms used in
agents at biosafety level 2 (5).
this test method, refer to Terminology D1129.
1.3 This standard does not purport to address all of the
3.2 Definitions of Terms Specific to This Standard:
safety concerns, if any, associated with its use. It is the
3.2.1 hygienic (health-care personnel) handwash agents,
n—agents generally used for handwashing by personnel in
1 hospitals, other health-care facilities, day-care centers, nursing
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antibacterial Agents.
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Current edition approved April 10, 2002. Published July 2002. Originally For referenced ASTM standards, visit the ASTM website, www.astm.org, or
published as E1838–96. Last previous edition E1838–96. DOI: 10.1520/E1838-02. 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.
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E1838–02
homes, and food-handling establishments should be safe for 5.3 Whereas, this test method relates to testing with viruses
repeated use, nonirritating, fast-acting, and efficient in elimi- of human origin, it can be readily adapted to work with
nating transient microorganisms from intact skin. bacteria, fungi, protozoa and bacteriophages.
5.4 Infectious microorganisms left on hands after washing
3.2.2 nonmedicated soap, n—a soap or detergent that is
canbered
...
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