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现行 ASTM E3243-21
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Standard Specification for Field Detection Equipment and Assays Used for Fentanyl and Fentanyl-Related Compounds 芬太尼和芬太尼相关化合物用现场检测设备和分析的标准规范
发布日期: 2021-05-01
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、从业人员和负责机构提供了一组通用参数,以使化学检测工具的能力与其特定应用的用户需求相匹配。 1.1.2 本规范描述了所需的测试样品组成、数量和基于统计的测试方法,用于评估现场芬太尼和芬太尼相关检测设备和分析的性能,如测试方法所述 E3290 . 本规范不涉及检测极限的估计。 1.1.3 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)团队的使用;在爆炸或其他危险环境或大气中使用;与个人防护装备(PPE)一起使用; 消防员、执法人员或FEMA城市搜救团队使用,特殊电磁兼容性需求,延长储存期和延长任务时间。这些具体要求可能适用于也可能不适用于所有化学检测系统。 1.2 操作概念- 化学检测系统用于检测或识别化学危害,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。这些系统的用途包括调查、监测和筛选样本,尤其是在对疑似芬太尼或芬太尼相关化合物作出反应期间。现场可部署系统应能承受与使用相关的严酷考验,包括但不限于在高温和低温下的操作和储存、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。 1.2.1 单位- 当为TM 2、TM3和TM4创建多组分测试样品时,固体和液体的所有成分百分比均表示为重量/体积百分比(mg/mL)。 1.3 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。 1.4 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 chemical detection tools with user needs for their specific application. 1.1.2 This specification describes required test sample compositions, amounts, and a statistically-based testing approach to be used for evaluating the performance of field fentanyl and fentanyl-related detection equipment and assays as described in Test Method E3290 . This specification does not address the estimation of limit of detection. 1.1.3 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; use in explosive or other hazardous environments or atmospheres; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or FEMA Urban Search & Rescue teams, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all chemical detection systems. 1.2 Operational Concepts— Chemical detection systems are used to detect or identify chemical 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 fentanyl or fentanyl-related compound. A field-deployable system should withstand the rigors associated with uses including, but not limited to, operation and storage in high and low temperatures, 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. 1.2.1 Units— When creating multicomponent test samples for TM 2, TM3, and TM4, all % compositions are stated as weight/volume percent (mg/mL) for both solid and liquids. 1.3 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. 1.4 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.
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归口单位: E54.01
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