【国外标准】 Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension

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 E1053, Test Method E2197) or in vivo (Test Method E1838) 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.21.6 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.