EN ISO 16640:2022
(Main)Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and radiopharmaceuticals (ISO 16640:2021)
Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and radiopharmaceuticals (ISO 16640:2021)
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.
Überwachung radioaktiver Gase in Ableitungen von Anlagen, die Positronen emittierende Radionuklide und Radiopharmaka produzieren (ISO 16640:2021)
Dieses Dokument behandelt die Überwachung der Aktivitätskonzentrationen radioaktiver Gase. Sie erlaubt die Berechnung der gasförmigen Aktivitätsableitungen mit der Fortluft aus Anlagen, die Positronen emittierende Radionuklide und Radiopharmaka herstellen. Solche Einrichtungen erzeugen kurzlebige Radionuklide für medizinische Zwecke oder für die Forschung und können Gase in die Umgebung abgeben, die üblicherweise, aber nicht ausschließlich 18F, 11C, 15O und 13N enthalten. Zu diesen Einrichtungen gehören Beschleuniger, Radiopharmaka, Kliniken und Universitäten. Dieses Dokument enthält leistungsbezogene Kriterien für die Ver¬wendung von Luftüberwachungseinrichtungen einschließlich Sonden, Transportleitungen, Probenüberwa¬chungsinstrumenten und Gasdurchfluss-Messverfahren. Es enthält auch Informationen zu den Zielen des Über¬wachungsprogramms, zur Qualitätssicherung, zur Entwicklung von Eingreifschwellenwerten bei der Steue¬rung der Luftüberwachung sowie zur Optimierung und Prüfung der Leistungsfähigkeit der Einrichtungen.
Das Ziel, eine unverfälschte Messung zu erhalten, wird entweder durch Direktmessung im Fortluftstrom (In-line) oder durch Entnahme von Luftproben aus dem Fortluftstrom (Bypass) erreicht, vorausgesetzt, dass die radioaktiven Gase im Luftstrom gut durchmischt sind. Dieses Dokument legt Leistungskriterien und Empfeh¬lungen fest, die dabei helfen, belastbare Messungen zu erhalten.
ANMERKUNG 1 Die Kriterien und Empfehlungen in diesem Dokument zielen auf eine Überwachung ab, die zur Erfüllung von Vorschriften und zur Kontrolle des Systems durchgeführt wird. Wenn bestehende Luftüberwachungseinrichtungen nicht den Leistungskriterien und Empfehlungen dieses Dokuments entsprechen, wird eine Bewertung der Leistungsfähigkeit der Einrichtung empfohlen. Wenn aufgrund einer Leistungsbeurteilung Mängel festgestellt werden, ist zu prüfen, ob eine Nach¬rüstung der Einrichtung erforderlich ist, und ob Korrekturmaßnahmen zu ergreifen sind, wo dies praktikabel ist.
ANMERKUNG 2 Die Kriterien und Empfehlungen dieses Dokuments gelten sowohl unter normalen als auch unter nicht normalen Betriebsbedingungen, vorausgesetzt, dass diese Bedingungen nicht die Erzeugung von Aerosolen oder Dämpfen beinhalten. Wenn im Normalbetrieb und/oder bei der Abweichung vom Normalbetrieb Aerosole und Dämpfe erzeugt wer¬den, gelten auch die Prinzipien der Aerosolsammlung nach ISO 2889.
Surveillance des gaz radioactifs dans les effluents des installations produisant des radionucléides et des produits radiopharmaceutiques émetteurs de positrons (ISO 16640:2021)
Le présent document porte sur la surveillance de la concentration volumique des gaz radioactifs. Ils permettent le calcul des rejets d'activité, dans les effluents gazeux libérés par les installations produisant des radionucléides et des produits radiopharmaceutiques émetteurs de positrons. De telles installations produisent des radionucléides à courte durée de vie qui sont utilisés à des fins médicales et de recherche, et peuvent libérer des gaz incluant généralement, mais sans s'y limiter, 18F, 11C, 15O et 13N. Ces installations comprennent les accélérateurs, les radiopharmacies, les hôpitaux et les universités. Le présent document spécifie des critères de performance pour la conception et l'utilisation d'équipements de surveillance de l'air comprenant des sondes, des lignes de transport et des instruments de surveillance des échantillons, ainsi que des méthodes de mesure de débit d'air. Il fournit également des informations couvrant les objectifs des programmes de surveillance, l'assurance qualité, l'élaboration de niveaux de déclenchement d'actions de régulation liées à la surveillance de l'air, l'optimisation des systèmes et la vérification des performances des systèmes.
L'objectif de réaliser un mesurage non biaisé est atteint soit par un mesurage direct (en ligne) sur le flux de rejets, soit par extraction d'échantillons du flux de rejets (en dérivation), à condition que les gaz radioactifs soient mélangés de façon homogène dans le flux d'air. Le présent document fournit des critères de performance et des recommandations destinées à faciliter la réalisation de mesurages valides.
NOTE 1 Les critères et les recommandations du présent document concernent la surveillance réalisée aux fins de vérification de la conformité à la réglementation et de contrôle des systèmes. Si les systèmes de surveillance d'air existants n'ont pas été conçus conformément aux critères de performance et aux recommandations du présent document, une évaluation des performances du système est recommandée. Si des écarts sont constatés sur la base d'une évaluation des performances, il convient de déterminer s'il est nécessaire de procéder à une modification a posteriori du système et de prendre des mesures correctives, le cas échéant.
NOTE 2 Les critères et les recommandations du présent document s'appliquent dans des conditions opérationnelles normales et anormales, sous réserve que ces conditions n'incluent pas la production d'aérosols ou de vapeurs. Si les conditions normales et/ou anormales produisent des aérosols et des vapeurs, alors les principes de collecte des aérosols de l'ISO 2889 s'appliquent également.
Nadzorovanje radioaktivnih plinov v iztokih iz obratov, ki proizvajajo radionuklide in radiofarmacevtske izdelke, ki oddajajo pozitrone (ISO 16640:2021)
Ta dokument se osredotoča na nadzorovanje koncentracij aktivnosti radioaktivnih plinov. Te koncentracije omogočajo izračun sproščanja aktivnosti v plinskih izpustih iz obratov, ki proizvajajo radionuklide in radiofarmacevtske izdelke, ki oddajajo pozitrone. Takšni obrati proizvajajo kratkožive radionuklide, ki se uporabljajo za medicinske namene ali raziskave, ter lahko sproščajo pline, ki običajno med drugim vključujejo 18F, 11C, 15O in 13N. Sem spadajo pospeševalniki, radiofarmacevtske lekarne, bolnišnice in univerze. Ta dokument zagotavlja merila, ki temeljijo na zmogljivosti, za načrtovanje in uporabo opreme za nadzor zraka, vključno s sondami, prevoznimi linijami, instrumenti za nadzorovanje vzorcev in metodami za merjenje pretoka plina. Vsebuje tudi informacije o ciljih programa nadzora, zagotavljanju kakovosti, razvoju stopenj ukrepov za nadzor zraka, optimizaciji sistema in preverjanju delovanja sistema.
Nepristranska meritev je dosežena z neposrednim (linijskim) merjenjem v izpušnem toku ali z vzorci, pridobljenimi iz izpušnega toka (obvod), pri čemer morajo biti radioaktivni plini dobro premešani v zračnem toku. Ta dokument določa kriterije zmogljivosti in priporočila za pomoč pri pridobivanju veljavnih meritev.
OPOMBA 1: Merila in priporočila v tem dokumentu so namenjena nadzoru, ki se izvaja za zagotavljanje skladnosti s predpisi in nadzora sistema. Če obstoječi sistemi nadzora zraka niso bili načrtovani v skladu z merili glede zmogljivosti in priporočili iz tega dokumenta, je priporočljivo oceniti zmogljivost sistema. Če so na podlagi ocene zmogljivosti odkrite pomanjkljivosti, je treba določiti potrebo po rekonstrukciji sistema in sprejeti korektivne ukrepe, kjer je to izvedljivo.
OPOMBA 2: Merila in priporočila v tem dokumentu se uporabljajo tako v običajnih kot neobičajnih pogojih delovanja, če taki pogoji ne zajemajo proizvodnje aerosolov ali hlapov. Če se v običajnih in/ali neobičajnih pogojih delovanja proizvajajo aerosoli in hlapi, se uporabljajo tudi načela zbiranja aerosolov iz standarda ISO 2889.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2023
Nadzorovanje radioaktivnih plinov v iztokih iz obratov, ki proizvajajo radionuklide
in radiofarmacevtske izdelke, ki oddajajo pozitrone (ISO 16640:2021)
Monitoring radioactive gases in effluents from facilities producing positron emitting
radionuclides and radiopharmaceuticals (ISO 16640:2021)
Surveillance des gaz radioactifs dans les effluents des installations produisant des
radionucléides et des produits radiopharmaceutiques émetteurs de positrons (ISO
16640:2021)
Ta slovenski standard je istoveten z: EN ISO 16640:2022
ICS:
13.030.30 Posebni odpadki Special wastes
13.060.25 Voda za industrijsko uporabo Water for industrial use
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16640
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 13.030.30; 13.280
English Version
Monitoring radioactive gases in effluents from facilities
producing positron emitting radionuclides and
radiopharmaceuticals (ISO 16640:2021)
Surveillance des gaz radioactifs dans les effluents des
installations produisant des radionucléides et des
produits radiopharmaceutiques émetteurs de
positrons (ISO 16640:2021)
This European Standard was approved by CEN on 18 December 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16640:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 16640:2021 has been prepared by Technical Committee ISO/TC 85 "Nuclear energy,
nuclear technologies, and radiological protection” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 16640:2022 by Technical Committee CEN/TC 430 “Nuclear
energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 16640:2021 has been approved by CEN as EN ISO 16640:2022 without any modification.
INTERNATIONAL ISO
STANDARD 16640
First edition
2021-01
Monitoring radioactive gases in
effluents from facilities producing
positron emitting radionuclides and
radiopharmaceuticals
Surveillance des gaz radioactifs dans les effluents des installations
produisant des radionucléides et des produits radiopharmaceutiques
émetteurs de positrons
Reference number
ISO 16640:2021(E)
©
ISO 2021
ISO 16640:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 16640:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 8
5 Factors impacting the design of the monitoring system .11
6 Types of monitoring systems .11
7 General monitoring system requirements .12
7.1 General .12
7.2 Detection range .12
7.3 Detector location .12
7.3.1 Background.12
7.3.2 Ease of accessibility for maintenance .13
7.3.3 Environmental conditions .13
7.4 Emission stream flow measurement .13
8 Requirements specific to bypass systems .13
8.1 General .13
8.2 Sample extraction locations .13
8.3 Condensation .14
8.4 Maintenance .14
8.5 Leak checks .15
9 Requirements specific to in-line systems .15
9.1 General .15
9.2 Location of the probe or detector .15
9.3 Environmental conditions .15
10 Evaluation and upgrading of existing systems .15
11 Quality assurance and quality control .16
Annex A (informative) Factors impacting the monitoring system design .18
Annex B (informative) Evaluating uncertainty of effluent measurement .31
Annex C (informative) Quality assurance .41
Annex D (informative) Mixing demonstration and sampling system performance verification .45
Annex E (informative) Techniques for measurement of flow rate through a stack or duct .49
Bibliography .51
ISO 16640:2021(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 85, Nucle
...
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