EN ISO 16640:2022

Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and radiopharmaceuticals (ISO 16640:2021)

Publication date:   May 15, 2023

Scope

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.