1.1 本规程旨在证明含有悬浮病毒的试验物质的杀病毒活性。 1.2 研究者有责任确定是否需要良好实验室规范（GLP），并在适当的情况下遵循这些规范（40 CFR，第160部分用于EPA提交，21 CFR，第58部分用于FDA提交）。 1.3 有关杀病毒效力的性能标准，请咨询相应的监管机构。 1.4 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 用户应参考实验室安全建议。 2. 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本规程旨在确定试验物质是否能使悬浮液中的病毒失活。 5.2 监管机构可能要求使用 体外 （实践 E1053 ，试验方法 E2197年 )或 体内 （试验方法 E1838 )用于产品注册的载体测试。

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. 2 1.6 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. ====== Significance And Use ====== 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.