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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 , Test Method ) or in vivo (Test Method ) carrier tests for product registration purposes.
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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
Federal Standards21 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
ICS Number Code 65.100.01 (Pesticides and other agrochemicals)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM E1052-20, Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension, ASTM International, West Conshohocken, PA, 2020, www.astm.orgBack to Top