1.1 本规程用于量化蒸汽去污剂对 芽孢杆菌 孢子在由多孔和非多孔材料制成的试样表面上干燥，并包含在0.2µm过滤盖管内。 1.2 这种做法只能由受过微生物技术培训、熟悉抗菌剂（杀孢子剂）和此类产品最终用途的人员执行。 1.3 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。 1.4 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。 1.5 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 本规程可用于评估任何成分的试片材料，只要试片可以制备得足够小，以适合50 ml锥形管内。 5.2 本规程定义了定量、可扩展、快速、敏感、安全、减少耗材、最小化劳动力和解决统计置信度的程序 ( 1. , 2. , 4. ) . 5.2.1 定量- 每个试片的孢子总数通过稀释电镀确定，并在提取管中对试片上剩余的所有孢子进行活性分析，以提供100%的置信度 % 对孢子的数量进行了分析。 5.2.2 统计置信度- 使用五种独立的孢子接种物制剂，统计N为5。 5.2.3 灵敏度- 允许完全检测接种在试片上的所有活孢子，包括仍然附着在试片上的孢子。 5.2.4 安全- 接种的试片包含在0.2范围内 µm过滤器盖50- ml锥形管。0.2 µm过滤器允许蒸汽去污剂通过，同时防止孢子逸出，因此在处理致病菌株时提供了重要的遏制水平。 5.2.5 测试的简单性- 在相同的50 ml锥形管中进行测试和提取，以尽量减少处理步骤。 5.2.6 可扩展且快速- 两名技术人员最多可在1小时内处理36个样品；六名技术人员在5小时内总共处理了300个样品 ( 1- 3. ) . 5.2.7 广泛应用于众多领域 芽孢杆菌 物种和菌株。 注1: 这种做法不同于类似的定量方法( E2111 , E2197年 和 E2414 )在可用于测试的试片材料的尺寸和种类、在统计的实际置信度、去污剂的应用、可扩展性和灵敏度方面。

1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes. 1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 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. ====== Significance And Use ====== 5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube. 5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence ( 1 , 2 , 4 ) . 5.2.1 Quantitative— The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed. 5.2.2 Statistical Confidence— The use of five independent preparations of spore inoculum for a statistical N of 5. 5.2.3 Sensitivity— Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon. 5.2.4 Safety— Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains. 5.2.5 Simplicity of Testing— Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps. 5.2.6 Scalable and Rapid— A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h ( 1- 3 ) . 5.2.7 Wide application for numerous Bacillus species and strains. Note 1: This practice differs from similar quantitative methods ( E2111 , E2197 and E2414 ) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.