ASTM E1052-11
(Test Method)Standard Test Method to Assess the Activity of Microbicides against Viruses in Suspension
Standard Test Method to Assess the Activity of Microbicides against Viruses in Suspension
SIGNIFICANCE AND USE
This test method is to determine if a test substance can inactivate viruses in suspension.
Regulatory agencies may require additional testing using in vitro (Test Methods E1053, E2197) or in vivo (Test Method E1838) carrier tests for product registration purposes.
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 limitations prior to use. The user should consult a reference for the laboratory safety recommendations.
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Designation: E1052 − 11
Standard Test Method 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 E1838 Test Method for Determining the Virus-Eliminating
Effectiveness of Hygienic Handwash and HandrubAgents
1.1 Thistestmethodisintendedtodemonstratethevirucidal
Using the Fingerpads of Adults
activity of test substances with viruses in suspension.
E2197 Quantitative Disk Carrier Test Method for Determin-
1.2 It is the responsibility of the investigator to determine
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
whether Good Laboratory Practice regulations (GLPs) are
and Sporicidal Activities of Chemicals
required and to follow them where appropriate (40 CFR, Part
E2756 Terminology Relating to Antimicrobial and Antiviral
160 for EPA submissions and 21 CFR, Part 58 for FDA
Agents
submissions).
4
2.2 Federal Standards:
1.3 Refer to the appropriate regulatory agency for perfor-
21 CFR Code of Federal Regulations (CFR), Food and Drug
mance standards of virucidal efficacy.
Administration, Part 58, Laboratory Practice for Nonclini-
1.4 The values stated in SI units are to be regarded as
cal Laboratory Studies
standard. No other units of measurement are included in this
40 CFR Code of Federal Regulations (CFR), Environmental
standard.
Protection Agency, Part 160, Good Laboratory Practice
1.5 This standard does not purport to address all of the
Standard
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety and health practices and determine the applica-
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
bility of regulatory limitations prior to use. The user should
test method, refer to Terminology E2756.
consult a reference for the laboratory safety recommenda-
2
tions.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 hard water, n—water with a standard hardness as
2. Referenced Documents
calcium carbonate.
3
2.1 ASTM Standards:
3.2.2 neutralization, n—the process for inactivating or
E1053 Test Method to Assess Virucidal Activity of Chemi-
quenchingtheactivityofamicrobicide,oftenachievedthrough
cals Intended for Disinfection of Inanimate, Nonporous
physical(forexample,filtrationordilution)orchemicalmeans.
Environmental Surfaces
3.2.2.1 Discussion—This neutralization may be achieved
E1482 TestMethodforNeutralizationofVirucidalAgentsin
through dilution of the test substance to reduce the microbi-
Virucidal Efficacy Evaluations
cidal activity, or through the use of chemical agents, called
neutralizers, to eliminate microbicidal activity.
1
This test method is under the jurisdiction of ASTM Committee E35 on
3.2.3 soil load, n—a solution of one or more organic and/or
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
inorganic substances added to the suspension of the test
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2011. Published October 2011. Originally
organism to simulate the presence of body secretions,
approved in 1985. Last previous edition published in 2002 as E1052 – 96 (2002),
excretions, or other extraneous substances.
which was withdrawn in July 2011 and reinstated in October 2011. DOI:
10.1520/E1052-11.
3.2.4 test substances or test formulation, n—a formulation
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, Fifth
which incorporates microbicidal ingredients.
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
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
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E1052 − 11
4. Summary of Test Method 6.2 Additional or equivalent materials and reagents specific
to the host recovery system may be necessary. The trained
4.1 One part of the virus suspension is added to nine parts
microbiologist or virologist is responsible to choose accord-
of the test substance, the mixture held at the desired tempera-
ingly as needed.
ture for the required contact time and then assayed f
...
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:E1052–96 (Reapproved 2002)
Standard Test Method for Efficacy ofAntimicrobialAgents
Against Viruses in SuspensionDesignation:E1052–11
Standard Test Method 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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1This laboratory test method is a suspension test used to evaluate the effectiveness of antimicrobial solutions against specific
viruses. 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.
1.3
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.
1.4ItistheresponsibilityoftheinvestigatortodeterminewhetherGoodLaboratoryPracticeregulations(GLPs)arerequiredand
to follow them where appropriate (40 CFR, Part 160 for EPA submissions andCFR, Part 58 for FDA submissions). Refer to the
appropriate regulatory agency for performance standards of virucidal efficacy.
2. Referenced Documents
2.1 ASTM Standards:
E1053TestMethodtoAssessVirucidalActivityofChemicalsIntendedforDisinfectionofInanimate,NonporousEnvironmental
Surfaces
3
ASTM Standards:
E1153Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces 1053 Test Method to
Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
E1482 Test Method for Neutralization of VirucidalAgents in Virucidal Efficacy EvaluationsTest Method for Neutralization of
Virucidal Agents in Virucidal Efficacy Evaluations
E1838 TestMethodforDeterminingtheVirus-EliminatingEffectivenessofHygienicHandwashandHandrubAgentsUsingthe
Fingerpads of Adults
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
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 Agents and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 10, 1996. Published December 1996. Originally published as E1052–85. Last previous edition E1052–85 (1990). DOI: 10.1520/E1052-
96R02.
Current edition approved Oct. 1, 2011. Published October 2011. Originally approved in 1985. Last previous edition published in 2002 as E1052–96 (2002), which was
withdrawn in July 2011 and reinstated in October 2011. DOI: 10.1520/E1052-11.
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, ThirdFifth Edition, U.S. Department of Health and Human Services, Washington, DC, May
1993.2009.
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
---------------------- Page: 1 ----------------------
E1052–11
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
2.2 Federal Standards:
Title 40,Code of Federal Regulations (CFR), Environmental Protection Agency, Part 160, Good Laboratory Practice Standard
4
Federal
...
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