ASTM International

ASTM E1052 - 11 standard test method to assess the activity of microbicides against viruses in suspension


Source: ASTM International

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)

ASTM Standards
E1053 Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
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 Evaluation

Federal Standards
Title21, Code of Federal Regulations (CFR), Food and Drug Administration, Part 58, Laboratory Practice for Nonclinical Laboratory Studies

Index Terms

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

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