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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.2 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.2
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.
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