1.1 本规范为系统设计者、制造商、集成商、采购人员、最终用户、从业者和其他负责机构提供了一套通用标准，以使现场筛查设备的功能与特定应用的用户要求相匹配。 1.2 本规范描述了所需的测试样品组成和数量，并提供了一种基于统计的测试方法，用于评估FSD检测生物制剂的性能，如测试方法所述 E3395 本说明书不涉及检测极限的估计。 1.3 单位: 1.3.1 以国际单位制表示的数值应视为本规范中的标准值。 1.3.2 当创建测试样品混合物时，所有浓度均以拷贝数/mL或基因组当量/mL（GE/mL）表示。 1.4 操作概念: 1.4.1 用于识别潜在危险生物制剂的FSD在旨在保护响应者和公众的决策过程中发挥着重要作用。合适的FSD需要低的假阳性率和假阴性率。FSD用于监测和样本筛查，是应对发现疑似含有生物制剂的样本的事件的一个特别重要的工具。FSD必须足够坚固，能够承受存储和操作条件，包括但不限于极端温度和湿度、冲击和振动、射频干扰以及快速的热和湿度变化。本规范不涉及表征操作极限或储存条件的测试。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。制造商、购买者和最终用户需要确定安全要求，包括但不限于危险品（HAZMAT）团队的使用；与个人防护装备（PPE）一起使用；消防员、执法人员或联邦紧急事务管理局（FEMA）城市搜救队的使用、特殊的电磁兼容性需求、延长的使用期限和延长的任务时间。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。

1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users, practitioners, and other responsible authorities with a common set of criteria to match field screening device capabilities with user requirements for specific applications. 1.2 This specification describes the required test sample compositions and amounts, and provides a statistically-based testing approach for evaluating FSD performance for the detection of biological agents as described in Test Method E3395 . This specification does not address the estimation of limit of detection. 1.3 Units: 1.3.1 Values stated in SI units are to be regarded as standard in this specification. 1.3.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL). 1.4 Operational Concepts: 1.4.1 FSDs used for identifying potentially dangerous biological agents play an important role in the decision-making processes intended to protect responders and the general public. Suitable FSDs require low rates of false positives and false negatives. FSDs are used for surveillance and sample screening, and they are a particularly important tool in responding to incidents where a sample suspected of containing a biological agent is found. FSDs must be rugged enough to withstand storage and operating conditions that include, but are not limited to, temperature and humidity extremes, shock and vibration, radio frequency interference, and rapid thermal and humidity changes. This specification does not address testing to characterize operating limits or storage conditions. 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. Manufacturers, purchasers, and end-users will need to determine safety requirements including, but not limited to, use by hazardous material (HAZMAT) teams; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or the Federal Emergency Management Agency (FEMA) Urban Search & Rescue (US&R) teams, special electromagnetic compatibility needs, extended usage periods, and extended mission time. 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.