ASTM E1053-20
(Practice)Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
SIGNIFICANCE AND USE
5.1 This practice may be used to determine the effectiveness of liquid, aerosols/foams, and trigger-spray products against designated prototype viruses.
5.2 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.
5.3 Certain regulatory agencies may require additional testing using other carrier tests for product registration purposes.
SCOPE
1.1 This practice is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, nonporous environmental surfaces. This practice may be employed with most viruses, which can be grown in cultured cells.2 However, other host systems (for example, embryonic eggs) may be used with proper justification and documentation.
1.2 This practice 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. The user should consult a reference for laboratory safety recommendations.2
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: E1053 − 20
Standard Practice 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 2. Referenced Documents
3
1.1 Thispracticeisusedtoevaluatethevirucidalefficacyof 2.1 ASTM Standards:
liquid, aerosol, or trigger-spray microbicides intended for use D1129Terminology Relating to Water
oninanimate,nonporousenvironmentalsurfaces.Thispractice E1153TestMethodforEfficacyofSanitizersRecommended
may be employed with most viruses, which can be grown in for Inanimate, Hard, Nonporous Non-Food Contact Sur-
2
cultured cells. However, other host systems (for example, faces
embryonic eggs) may be used with proper justification and E1482Practice for Use of Gel Filtration Columns for Cyto-
documentation. toxicity Reduction and Neutralization
E2197Quantitative Disk Carrier Test Method for Determin-
1.2 This practice should be performed only by those trained
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
in microbiological and virological techniques in facilities
and Sporicidal Activities of Chemicals
designed and equipped for work with infectious agents at the
4
2.2 Federal Standards:
appropriate biosafety level.
Title21,CodeofFederalRegulations(CFR),FoodandDrug
1.3 It is the responsibility of the investigator to determine
Administration,Part58,LaboratoryPracticeforNonclini-
whether Good Laboratory Practice regulations (GLPs) are
cal Laboratory Studies
required and to follow them where appropriate (40 CFR, Part
Title40,CodeofFederalRegulations(CFR),Environmental
160 for EPA submissions and 21 CFR, Part 58 for FDA
Protection Agency, Subchapter E, Pesticide Programs;
submissions). Refer to the appropriate regulatory agency for
Part 160, Good Laboratory Practice Standards
performance standards of virucidal efficacy.
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—Fordefinitionsofgeneraltermsusedinthis
responsibility of the user of this standard to establish appro-
test method, refer to Terminology D1129.
priate safety, health, and environmental practices and deter-
3.2 Definitions of Terms Specific to This Standard:
mine the applicability of regulatory limitations prior to use.
3.2.1 hard water, n—water with a standard hardness as
The user should consult a reference for laboratory safety
2
calcium carbonate.
recommendations.
1.5 This international standard was developed in accor-
3.2.2 neutralization, n—a process which results in quench-
dance with internationally recognized principles on standard-
ing the microbicidal activity of a test substance. This may be
ization established in the Decision on Principles for the
achieved through dilution of the test substance to reduce the
Development of International Standards, Guides and Recom-
microbicidal activity, or through the use of chemical agents,
mendations issued by the World Trade Organization Technical
called neutralizers, to eliminate microbicidal activity.
Barriers to Trade (TBT) Committee.
3.2.3 soil load, n—a solution of one or more organic and/or
inorganic substances added to the suspension of the test
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
3
Current edition approved Jan. 1, 2020. Published March 2020. Originally For referenced ASTM standards, visit the ASTM website, www.astm.org, or
approved in 1985. Last previous edition approved in 2011 as E1053–11. DOI: contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
10.1520/E1053-20. Standards volume information, refer to the standard’s Document Summary page on
2
Public Health Service, Centers for Disease Control and Prevention, and the ASTM website.
4
National Institutes of Health, Biosafety in Microbiological and Biomedical AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Laboratories, U.S. Department of Health and Human Services, Washington, DC, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
December 2009, 422 pp. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United State
...
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: E1053 − 11 E1053 − 20
Standard Test Method Practice 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
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
3
2.1 ASTM Standards:
D1129 Terminology Relating to Water
E1153 Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces
E1482 Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
4
2.2 Federal Standards:
Title 21, Code of Federal Regulations (CFR), Food and Drug Administration, Part 58, Laboratory Practice for Nonclinical
Laboratory Studies
Title 40, Code of Federal Regulations (CFR), Environmental Protection Agency, Subchapter E, Pesticide Programs; Part 160,
Good Laboratory Practice Standards
3. Terminology
3.1 Definitions—For definitions of general terms used in this test method, refer to Terminology D1129.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 hard water, n—water with a standard hardness as calcium carbonate.
1
This test method practice 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 Jan. 1, 2011Jan. 1, 2020. Published March 2011March 2020. Originally approved in 1985. Last previous edition approved in 20022011 as
E1053 – 97 (2002).E1053 – 11. DOI: 10.1520/E1053-11.10.1520/E1053-20.
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
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.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E1053 − 20
3.2.2 neutralization, n—a process which results in quenching the microbicidal activity of a test substance. This may be achieved
through dilution of the test substance to reduce the microbicidal activity, or through the use of chemical agents, called neutralizers,
to eliminate microbicidal activity.
3.2.3 soil load, n—a solution of one or more organic and/or inorganic substances added to the suspension of
...
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