ASTM E1838-17
(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
5.1 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 contaminated with virus and used in a given test, it allows for the incorporation of a wet inoculum input control, dried virus recovery control, and up to three replicates to assess the virus-eliminating efficiency of a test or control agent, or a vehicle material. No more than 100 μL of the virus suspension are required to complete one test.
5.2 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 (12).
5.3 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.
5.4 Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (13). A step for the drying of fingerpads after exposure to the control or test product, therefore, has not been included to avoid virus removal by the drying process itself.
5.5 This test method is not meant for use with surgical hand scrubs or preoperative skin preps.
5.6 The level of viable virus in the dried inocula the control fingerpads should not be less than 104 infectious units which would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by the test product under the conditions of this test method.
SCOPE
1.1 Human skin is not known to carry viruses as a part of its resident microbiota, with the notable exception of papilloma viruses (10). 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 (11).
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.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1838 − 17
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
2
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, 6, 7, 8, 9). This test method
is to assess the virus-eliminating potential of handwash and handrub agents in vivo.
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, with the notable exception of papilloma
1.5 This international standard was developed in accor-
viruses (10). Hands transiently contaminated with viruses can,
dance with internationally recognized principles on standard-
however, act as vehicles for the spread of many types of viral
ization established in the Decision on Principles for the
infections.Handhygieneismeanttoreducetheloadofviruses
Development of International Standards, Guides and Recom-
andothertransientmicroorganismsonhands,therebyreducing
mendations issued by the World Trade Organization Technical
the risk of disease transmission. Such reductions in the virus
Barriers to Trade (TBT) Committee.
load may be due to a combination of virus inactivation and
mechanical removal of infectious virus from the skin.
2. Referenced Documents
1.2 This test method is designed to determine the compara- 3
2.1 ASTM Standards:
tive virus-eliminating effectiveness of microbicidal or non-
E2011Test Method for Evaluation of Hygienic Handwash
microbicidal formulations. This test method is not meant for
and Handrub Formulations for Virus-EliminatingActivity
use with surgical hand scrubs or preoperative skin preps.
Using the Entire Hand
NOTE1—Thetestmethodshouldbeperformedbypersonswithtraining E2276 Test Method for Determining the Bacteria-
in virology in facilities designed and equipped for work with infectious
Eliminating Effectiveness of Hygienic Handwash and
agents at biosafety level 2 (11).
Handrub Agents Using the Fingerpads of Adults
1.3 The values stated in SI units are to be regarded as
E2613Test Method for Determining Fungus-Eliminating
standard. No other units of measurement are included in this
EffectivenessofHygienicHandwashandHandrubAgents
standard.
Using Fingerpads of Adults
1.4 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Definitions of Terms Specific to This Standard:
1
3.1.1 Health-care personnel (HCP), n—persons who are
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
directly related to provision of health care services. It includes
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2017. Published June 2017. Originally
3
approved in 1996. Last previous edition approved in 2010 as E1838–10. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E1838-17. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
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
1
---------------------- Page: 1 ----------------------
E1838 − 17
all paid and unpaid persons working in health-care settings, to assess the virus-eliminating efficiency of a test or control
such as physicians, nurses, nursing assistants, therapi
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 10 E1838 − 17
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. A number 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 hand hygiene
is crucial in preventing such spread, particularly in health-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
2
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, 6, 7, 8, 9). Standardized
methods This test method is to assess the virus-eliminating potential of handwash and handrub agents
have not in vivo.been available and this test method addresses the gap.
1. Scope
1.1 Human skin is not known to carry viruses as a part of its resident microbiota. microbiota, with the notable exception of
papilloma viruses (10). 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 (611).
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.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
E2011 Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the
Entire Hand
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2010April 1, 2017. Published May 2010.June 2017. Originally approved in 1996. Last previous edition approved in 20022010 as
E1838 – 02.E1838 – 10. DOI: 10.1520/E1838-10.10.1520/E1838-17.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1838 − 17
E2276 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using
the Fingerpads of Adults
E2613 Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using
Fingerpads of Adults
...
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