ISO 16640:2021 监测生产发射正电子的放射性核素和放射性药品的设施排出物中的放射性气体
标准编号：ISO 16640:2021
中文名称：监测生产发射正电子的放射性核素和放射性药品的设施排出物中的放射性气体
英文名称：Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and radiopharmaceuticals
发布日期：2021-01
标准范围
本文件侧重于监测放射性气体的活度浓度。它们允许计算从生产发射正电子的放射性核素和放射性药物的设施排出的气态流出物中的活度释放。此类设施产生用于医疗目的或研究的短寿命放射性核素，并可释放通常包括但不限于18F、11C、15O和13N的气体。这些设施包括加速器、放射性药房、医院和大学。此文档提供性能？空气监测设备的设计和使用标准，包括探头、输送管线、样品监测仪器和气体流量测量方法。本文件还提供了有关监测计划目标、质量保证、空气监测控制行动水平的制定、系统优化和系统性能验证的信息。实现无偏测量的目标是通过对排气流的直接（在线）测量或从排气流中提取的样品（旁路）来实现的，前提是放射性气体在气流中充分混合。本文件规定了性能标准和建议，以帮助获得有效的测量结果。注1本文件的标准和建议旨在监测法规遵从性和系统控制。如果现有空气监测系统不是根据本文件的性能标准和建议设计的，建议对系统的性能进行评估。如果根据性能评估发现缺陷，将确定是否需要进行系统改造，并在可行的情况下采取纠正措施。注2本文件的标准和建议适用于正常和关闭？正常操作条件，前提是这些条件不包括气溶胶或蒸汽的产生。如果正常和/或异常条件产生气溶胶和蒸汽，则ISO 2889的气溶胶收集原则也适用。
This document focuses on monitoring the activity concentrations of radioactive gases. They allow the calculation of the activity releases, in the gaseous effluent discharge from facilities producing positron emitting radionuclides and radiopharmaceuticals. Such facilities produce short-lived radionuclides used for medical purposes or research and can release gases typically including, but not limited to 18F, 11C, 15O and 13N. These facilities include accelerators, radiopharmacies, hospitals and universities. This document provides performance？based criteria for the design and use of air monitoring equipment including probes, transport lines, sample monitoring instruments, and gas flow measuring methods. This document also provides information on monitoring program objectives, quality assurance, development of air monitoring control action levels, system optimisation and system performance verification.The goal of achieving an unbiased measurement is accomplished either by direct (in-line) measurement on the exhaust stream or with samples extracted from the exhaust stream (bypass), provided that the radioactive gases are well mixed in the airstream. This document sets forth performance criteria and recommendations to assist in obtaining valid measurements.NOTE 1 The criteria and recommendations of this document are aimed at monitoring which is conducted for regulatory compliance and system control. If existing air monitoring systems were not designed according to the performance criteria and recommendations of this document, an evaluation of the performance of the system is advised. If deficiencies are discovered based on a performance evaluation, a determination of the need for a system retrofit is to be made and corrective actions adopted where practicable.NOTE 2 The criteria and recommendations of this document apply under both normal and off？normal operating conditions, provided that these conditions do not include production of aerosols or vapours. If the normal and/or off-normal conditions produce aerosols and vapours, then the aerosol collection principles of ISO 2889 also apply.
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