ASTM E1053-11
(Test Method)Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
SIGNIFICANCE AND USE
This test method may be used to determine the effectiveness of liquid, aerosols/foams, and trigger-spray products against designated prototype viruses.
The number of lots of the test substance and the number of replicates in each test will depend on the requirements of the target regulatory agency.
Certain regulatory agencies may require additional testing using other carrier tests for product registration purposes.
SCOPE
1.1 This test method is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, nonporous environmental surfaces. This test method may be employed with most viruses, which can be grown in cultured cells. However, other host systems (for example, embryonic eggs) may be used with proper justification and documentation.
1.2 This test method should be performed only by those trained in microbiological and virological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level.
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.
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. The user should consult a reference for laboratory safety recommendations.
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Designation: E1053 − 11
Standard Test Method to
Assess Virucidal Activity of Chemicals Intended for
Disinfection of Inanimate, Nonporous Environmental
1
Surfaces
This standard is issued under the fixed designation E1053; 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.
1. Scope E1153 Test Method for Efficacy of Sanitizers Recommended
for Inanimate Non-Food Contact Surfaces
1.1 This test method is used to evaluate the virucidal
E1482 TestMethodforNeutralizationofVirucidalAgentsin
efficacy of liquid, aerosol, or trigger-spray microbicides in-
Virucidal Efficacy Evaluations
tended for use on inanimate, nonporous environmental sur-
E2197 Quantitative Disk Carrier Test Method for Determin-
faces. This test method may be employed with most viruses,
2 ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
which can be grown in cultured cells. However, other host
and Sporicidal Activities of Chemicals
systems (for example, embryonic eggs) may be used with
4
2.2 Federal Standards:
proper justification and documentation.
Title21, CodeofFederalRegulations(CFR),FoodandDrug
1.2 This test method should be performed only by those
Administration, Part 58, Laboratory Practice for Nonclini-
trained in microbiological and virological techniques in facili-
cal Laboratory Studies
ties designed and equipped for work with infectious agents at
Title40, CodeofFederalRegulations(CFR),Environmental
the appropriate biosafety level.
Protection Agency, Subchapter E, Pesticide Programs;
1.3 It is the responsibility of the investigator to determine Part 160, Good Laboratory Practice Standards
whether Good Laboratory Practice regulations (GLPs) are
3. Terminology
required and to follow them where appropriate (40 CFR, Part
160 for EPA submissions and 21 CFR, Part 58 for FDA
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
submissions). Refer to the appropriate regulatory agency for
test method, refer to Terminology D1129.
performance standards of virucidal efficacy.
3.2 Definitions of Terms Specific to This Standard:
1.4 This standard does not purport to address all of the
3.2.1 hard water, n—water with a standard hardness as
safety concerns, if any, associated with its use. It is the
calcium carbonate.
responsibility of the user of this standard to establish appro-
3.2.2 neutralization, n—a process which results in quench-
priate safety and health practices and determine the applica-
ing the microbicidal activity of a test substance. This may be
bility of regulatory limitations prior to use. The user should
achieved through dilution of the test substance to reduce the
2
consult a reference for laboratory safety recommendations.
microbicidal activity, or through the use of chemical agents,
called neutralizers, to eliminate microbicidal activity.
2. Referenced Documents
3
3.2.3 soil load, n—a solution of one or more organic and/or
2.1 ASTM Standards:
inorganic substances added to the suspension of the test
D1129 Terminology Relating to Water
organism to simulate the presence of body secretions, excre-
tions or other extraneous substances.
1
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
3.2.4 test substance or test formulation, n—a formulation
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
which incorporates microbicidal ingredients.
Current edition approved Jan. 1, 2011. Published March 2011. Originally
approved in 1985. Last previous edition approved in 2002 as E1053 – 97 (2002).
4. Summary of Test Method
DOI: 10.1520/E1053-11.
2
Public Health Service, Centers for Disease Control and Prevention, and
4.1 The virus suspension is dried on an inanimate, nonpo-
National Institutes of Health, Biosafety in Microbiological and Biomedical
rous surface. The test substance is added over the dried film at
Laboratories, U.S. Department of Health and Human Services, Washington, DC,
December 2009, 422 pp.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
the ASTM website. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1053 − 11
its use-dilution or sprayed from an aerosol
...
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:E1053–97 (Reapproved 2002)
Standard Test Method for Efficacy of Virucidal Agents
Intended for Inanimate Environmental
SurfacesDesignation: E1053 – 11
Standard Test Method to
Assess Virucidal Activity of Chemicals Intended for
Disinfection of Inanimate, Nonporous Environmental
1
Surfaces
This standard is issued under the fixed designation E1053; 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.
1. Scope
1.1Thislaboratorytestmethodisusedtoevaluatethevirucidalefficacyofliquid,aerosol,ortriggersprayantimicrobialsolutions
on inanimate nonporous environmental surfaces. This test method may be employed with most viruses and is designed for cell
culture host systems.
1.2This test method should be performed only by those trained in microbiological or virological techniques.
1.3This 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 the laboratory safety recommendations.
1.4ItistheresponsibilityoftheinvestigatortodeterminewhetherGoodLaboratoryPracticeregulations(GLPs)arerequiredand
to follow them where appropriate (40 CFR, Part 160 for EPA
1.1 This test method is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use
on inanimate, nonporous environmental surfaces. This test method may be employed with most viruses, which can be grown in
2
cultured cells. However, other host systems (for example, embryonic eggs) may be used with proper justification and
documentation.
1.2 This test method should be performed only by those trained in microbiological and virological techniques in facilities
designed and equipped for work with infectious agents at the appropriate biosafety level.
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice regulations (GLPs) are required
and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). Refer
to the appropriate regulatory agency for performance standards of virucidal efficacy.
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
2
limitations prior to use. The user should consult a reference for laboratory safety recommendations.
2. Referenced Documents
2.1 ASTM Standards:
3
E1052Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension ASTM Standards:
D1129 Terminology Relating to Water
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides and is the direct responsibility of Subcommittee on Pesticides, Antimicrobials, and
Alternative Control Methods and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 10, 1997. Published June 1997. Originally published as E1053–85. Last previous edition E1053–91. DOI: 10.1520/E1053-97R02.
Current edition approved Jan. 1, 2011. Published March 2011. Originally approved in 1985. Last previous edition approved in 2002 as E1053–97 (2002). DOI:
10.1520/E1053-11.
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, 3rd ed., U.S. Department of Health and Human Services, Washington, DC, May 1993.
2
Public Health Service, Centers for Disease Control and Prevention, and National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Washington, DC, December 2009, 422 pp.
3
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@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
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E1053 – 11
E1153 Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfa
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