【国外标准】 Standard Specification for Field Detection Equipment and Assays Used for Fentanyl and Fentanyl-Related Compounds

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.