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现行 ASTM E2895-19
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Standard Practice for Producing High Titers of Viable and Semi-Purified Spores of Clostridium difficile using a Liquid Medium 用液体培养基生产高滴度艰难梭菌活孢子和半纯化孢子的标准实施规程
发布日期: 2019-04-01
1.1 本规程描述了 C、 难辨的 主要用于测试环境表面消毒剂杀孢子活性的孢子(也称为内孢子)(测试方法 E2111 和 E2197年 ); 这种孢子也可以用来研究其结构、化学和萌发。 1.2 虽然所述实践基于在厌氧培养箱中使用500 mL体积的液体培养基,但也可以使用相同培养基体积较小的厌氧罐。 1.3 研究者有责任确定是否需要良好实验室实践(GLP)法规,并在适当时遵循这些法规(40 CFR,第160部分用于EPA提交,21 CFR;第58部分用于FDA提交)。 1.4 警告- 本标准可能涉及危险材料、化学品和微生物,只能由受过正规微生物学培训的人员执行。 1.5 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。 1.6 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。 1.7 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 本规程产生的孢子的数量和质量可用于评估环境表面消毒剂的杀孢子活性 ( 4. ) . 该方法适用于标准菌株和临床分离的产毒和非产毒菌株 C、 难辨的 .
1.1 This practice describes the production and semipurification of C. difficile spores (also called endospores) primarily for use in testing the sporicidal activities of environmental surface disinfectants (Test Methods E2111 and E2197 ); such spores can also be used to study their structure, chemistry and germination. 1.2 While the practice described is based on the use of 500-mL volumes of the liquid culture medium in an anaerobic incubator, anaerobic jars with smaller volumes of the same medium can also be used. 1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice (GLP) regulations are required and to follow them when appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR; Part 58 for FDA submissions). 1.4 Warning— This standard may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 The quantity and quality of the spores produced by this practice may be used to assess environmental surface disinfectants for sporicidal activity ( 4 ) . The method is applicable to standard as well as clinically isolated toxigenic and non-toxigenic strains of C. difficile .
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归口单位: E35.15
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