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.
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 limitations prior to use. The user should consult a reference for the laboratory safety recommendations.
2. Referenced Documents (purchase separately)
The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E1053 Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
E1482 Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
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
Federal Standards
40CFR Code of Federal Regulations (CFR), Environmental Protection Agency, Part 160, Good Laboratory Practice Standard
Keywords
cell cultures; microbicide; suspension test; virucidal test; virucide; viruses in suspension: Cytotoxicity; Disinfectants/disinfection; Efficacy; Embryonated eggs; Laboratory environmental analysis; Microbiological examination; Suspension tests; Tissue culture host systems; Virology;
ICS Code
ICS Number Code 65.100.01 (Pesticides and other agrochemicals)
DOI: 10.1520/E1052-11
ASTM International is a member of CrossRef.
Citing ASTM Standards
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