ASTM E1052-20
(Practice)Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension
Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension
SIGNIFICANCE AND USE
5.1 This practice is to determine if a test substance can inactivate viruses in suspension.
5.2 Regulatory agencies may require additional testing using in vitro (Practice E1053, Test Method E2197) or in vivo (Test Method E1838) carrier tests for product registration purposes.
SCOPE
1.1 This practice is intended to demonstrate the virucidal activity of test substances with viruses in suspension.
1.2 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).
1.3 Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 the laboratory safety recommendations.2
1.6 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: E1052 − 20
Standard Practice to
Assess the Activity of Microbicides against Viruses in
1
Suspension
This standard is issued under the fixed designation E1052; 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 E1053 Practice to Assess Virucidal Activity of Chemicals
Intended for Disinfection of Inanimate, Nonporous Envi-
1.1 This practice is intended to demonstrate the virucidal
ronmental Surfaces
activity of test substances with viruses in suspension.
E1482 Practice for Use of Gel Filtration Columns for Cyto-
1.2 It is the responsibility of the investigator to determine
toxicity Reduction and Neutralization
whether Good Laboratory Practice regulations (GLPs) are
E1838 Test Method for Determining the Virus-Eliminating
required and to follow them where appropriate (40 CFR, Part
Effectiveness of Hygienic Handwash and HandrubAgents
160 for EPA submissions and 21 CFR, Part 58 for FDA
Using the Fingerpads of Adults
submissions).
E2197 Quantitative Disk Carrier Test Method for Determin-
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
1.3 Refer to the appropriate regulatory agency for perfor-
mance standards of virucidal efficacy. and Sporicidal Activities of Chemicals
E2756 Terminology Relating to Antimicrobial and Antiviral
1.4 The values stated in SI units are to be regarded as
Agents
standard. No other units of measurement are included in this
4
2.2 Federal Standards:
standard.
21 CFR Code of Federal Regulations (CFR), Food and Drug
1.5 This standard does not purport to address all of the
Administration, Part 58, Laboratory Practice for Nonclini-
safety concerns, if any, associated with its use. It is the
cal Laboratory Studies
responsibility of the user of this standard to establish appro-
40 CFR Code of Federal Regulations (CFR), Environmental
priate safety, health, and environmental practices and deter-
Protection Agency, Part 160, Good Laboratory Practice
mine the applicability of regulatory limitations prior to use.
Standard
The user should consult a reference for the laboratory safety
2
recommendations.
3. Terminology
1.6 This international standard was developed in accor-
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
dance with internationally recognized principles on standard-
test method, refer to Terminology E2756.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3.2 Definitions of Terms Specific to This Standard:
mendations issued by the World Trade Organization Technical
3.2.1 hard water, n—water with a standard hardness as
Barriers to Trade (TBT) Committee.
calcium carbonate.
3.2.2 neutralization, n—the process for inactivating or
2. Referenced Documents
quenchingtheactivityofamicrobicide,oftenachievedthrough
3
2.1 ASTM Standards:
physical(forexample,filtrationordilution)orchemicalmeans.
3.2.2.1 Discussion—This neutralization may be achieved
through dilution of the test substance to reduce the microbi-
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
cidal activity, or through the use of chemical agents, called
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
neutralizers, to eliminate microbicidal activity.
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Jan. 1, 2020. Published March 2020. Originally
3.2.3 soil load, n—a solution of one or more organic and/or
approved in 1985. Last previous edition published in 2011 as E1052 – 11. DOI:
inorganic substances added to the suspension of the test
10.1520/E1052-20.
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, Fifth
organism to simulate the presence of body secretions,
Edition, U.S. Department of Health and Human Services, Washington, DC, May
excretions, or other extraneous substances.
2009.
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
4
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Government Printing Office, Superintendent of
the ASTM website. Documents, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1052 − 20
NOTE 3—Microtitration kit may be purchased from most laboratory
3.2.4
...
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: E1052 − 11 E1052 − 20
Standard Test Method Practice to
Assess the Activity of Microbicides against Viruses in
1
Suspension
This standard is issued under the fixed designation E1052; 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 intended to demonstrate the virucidal activity of test substances with viruses in suspension.
1.2 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).
1.3 Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 the laboratory safety recommendations.
2. Referenced Documents
3
2.1 ASTM Standards:
E1053 Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental
Surfaces
E1482 Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the
Fingerpads of Adults
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
4
2.2 Federal Standards:
21 CFR Code of Federal Regulations (CFR), Food and Drug Administration, Part 58, Laboratory Practice for Nonclinical
Laboratory Studies
40 CFR Code of Federal Regulations (CFR), Environmental Protection Agency, Part 160, Good Laboratory Practice Standard
3. Terminology
3.1 Definitions—For definitions of general terms used in this test method, refer to Terminology E2756.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 hard water, n—water with a standard hardness as calcium carbonate.
3.2.2 neutralization, n—the process for inactivating or quenching the activity of a microbicide, often achieved through physical
(for example, filtration or dilution) or chemical means.
3.2.2.1 Discussion—
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 Oct. 1, 2011Jan. 1, 2020. Published October 2011March 2020. Originally approved in 1985. Last previous edition published in 20022011 as
E1052 – 96 (2002)E1052 – 11., which was withdrawn in July 2011 and reinstated in October 2011. DOI: 10.1520/E1052-11. DOI: 10.1520/E1052-20.
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition, U.S. Department of Health and Human Services, Washington, DC, May 2009.
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, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1052 − 20
This neutralization 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 the test organism
to simulate the presence of body secretions, excretions, or other extraneous substances.
3.2.4 test substances or test formulation, n—a formulation which incorporates microbicidal ingredients.
4. Summ
...
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