Significance and Use

This test method may be used to determine the effectiveness of liquid, aerosols/foams, and trigger-spray products against designated prototype viruses.

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.

Certain regulatory agencies may require additional testing using other carrier tests for product registration purposes.

1. Scope

1.1 This test method is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, nonporous environmental surfaces. This test method 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 test method 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 and health practices and determine the applicability of regulatory limitations prior to use. The user should consult a reference for 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

D1129 Terminology Relating to Water

E1153 Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces

E1482 Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations

E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals

Federal Standards

Keywords

carrier test; cell or other tissue cultures; disinfectant; infection control; microbicide; surface test; virucidal test; virus; viruses on dried environmental surfaces; Cytotoxicity; Disinfectants/disinfection; Efficacy; Embryonated eggs; Inanimate surfaces; Laboratory environmental analysis; Microbiological examination; Surface analysis--environmental applications; Suspension tests; Tissue culture host systems; Virology;

ICS Code

ICS Number Code 65.100.01 (Pesticides and other agrochemicals)

DOI: 10.1520/E1053-11

ASTM International is a member of CrossRef.

ASTM E1053