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Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations 确定手部防腐配方的残留杀伤活性的标准试验方法
发布日期: 2016-11-15
1.1 本试验方法旨在测定皮肤防腐剂对手上暂时性微生物皮肤菌群的残留杀灭活性。 2. 它可用于评估在水的帮助下使用并冲洗掉的产品,以及在没有水的帮助下使用但未冲洗掉的产品。 1.2 执行本程序需要了解与人体保护相关的法规(见21 CFR第50和56部分)。 1.3 本试验方法应由受过微生物学培训的人员在设计和配备用于生物安全2级潜在传染源工作的设施中进行。 1.4 单位- 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和健康实践,并确定监管限制的适用性。 有关更具体的预防说明,请参阅 8.1 . ====意义和用途====== 5.1 许多市场上销售的手部防腐剂声称具有“长效保护”或“延长杀菌时间”(例如6小时),这通常基于测试方法中所述的测试结果 E1882 或指南 E2752 ,或两者兼而有之。目前还没有标准方法来评估手部防腐剂配方在产品使用后的某个时间发生“干燥”污染事件时杀死手部微生物的能力。 本试验方法提供了一种方法来证实手部防腐剂的残留杀灭声明。
1.1 This test method is designed to determine the residual killing activity of skin antiseptics against transient microbial skin flora on the hands. 2 It may be used to evaluate products that are used with the aid of water and rinsed off and those that are used without the aid of water and not rinsed off. 1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56). 1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2. 1.4 Units— 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. For more specific precautionary statements see 8.1 . ====== Significance And Use ====== 5.1 Many marketed hand antiseptics make claims of "long-lasting protection” or “extended kill” (for example 6 hours), which are typically based on results of testing as described in Test Method E1882 or Guide E2752 , or both. At this time there are no standard methods for evaluating a hand antiseptic formulation for its ability to kill microorganisms on hands when a “dry” contamination event occurs at some time after product use. This test method provides a method to substantiate residual kill claims for hand antiseptics.
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归口单位: E35.15
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