1.1 概述: 1.1.1 本规范为系统设计师、制造商、集成商、采购人员、最终用户/从业者和负责当局提供了一组通用参数，以使生物评估工具的能力与用户需求相匹配。 1.1.2 本规范并非旨在提供所有用途。制造商、购买者和最终用户需要确定具体要求，包括但不限于危险品（HAZMAT）团队和城市搜索救援（US&R）团队的使用、在爆炸或其他危险环境或大气中的使用、与个人防护装备（PPE）一起使用、消防员或执法人员使用或两者兼有，特殊的电磁兼容性需求、延长的存储期和延长的任务时间。 这些具体要求可能适用于也可能不适用于所有基于核酸的检测系统。 1.2 操作概念- 基于核酸的检测系统用于检测、识别、量化或组合生物危害，以支持短期战术决策，保护响应者和公众。系统应提供较低的假阳性率和假阴性率。这些系统的使用包括调查、监视和筛选样本，尤其是在应对疑似生物制剂事件期间。现场可部署系统应能承受与使用相关的严酷条件，包括但不限于高温和低温、储存条件、冲击和振动、射频干扰以及工作温度和湿度的快速变化。 请注意，本规范未涉及测试与现场系统使用相关的严格性的潜在影响。 1.3 基于核酸的系统检测能力- 制造商或独立的第三方测试实体应记录并通过测试验证系统的能力。 1.4 单位- 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。生物危害物质的液体浓度以病原体（如细菌和孢子）的生物制剂数量或每体积的基因组当量表示（生物制剂/毫升、基因组当量/毫升（GE/毫升）、菌落形成单位/毫升（CFU/毫升）或孢子/毫升）。 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。 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。

1.1 General: 1.1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match the capabilities of biological assessment tools with user needs. 1.1.2 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams and Urban Search and Rescue (US&R) teams, use in explosive or other hazardous environments or atmospheres, use with personal protective equipment (PPE), use by firefighters or law enforcement officers or both, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all nucleic acid-based detection systems. 1.2 Operational Concepts— Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident. A field-deployable system should withstand the rigors associated with uses including, but not limited to, high- and low-temperatures and storage conditions, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field. 1.3 Nucleic Acid-Based System Detection Capabilities— Manufacturers or independent third-party testing entities shall document and verify, through testing, the capabilities of the system. 1.4 Units— The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. Liquid concentrations of the biohazard materials are presented in number of biological agents or genome equivalents per volume for pathogens such as bacteria and spores (biological agents/mL, genome equivalents/mL (GE/mL), colony forming units/mL (CFU/mL), or spores/mL). 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. 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.