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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.
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. 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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Federal StandardsTitle 21, Code of Federal Regulations (CFR), Food and Drug Administration, Part 58, Laboratory Practice for Nonclinical Laboratory Studies Title 40,
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
ICS Number Code 65.100.01 (Pesticides and other agrochemicals)
UNSPSC Code 10191500(Pesticides or pest repellents)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM E1053-20, Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces, ASTM International, West Conshohocken, PA, 2020, www.astm.orgBack to Top