Surveillance des gaz radioactifs dans les effluents des installations produisant des radionucléides et des produits radiopharmaceutiques émetteurs de positrons

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FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 16640
ISO/TC 85/SC 2
Monitoring radioactive gases in
Secretariat: AFNOR
effluents from facilities producing
Voting begins on:
2020­10­19 positron emitting radionuclides and
radiopharmaceuticals
Voting terminates on:
2020­12­14
Surveillance des gaz radioactifs dans les effluents des installations
produisant des radionucléides et des produits radiopharmaceutiques
émetteurs de positrons
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 16640:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 16640:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 16640:2020(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 ..........................................................................................10

6 Types of monitoring systems ................................................................................................................................................................11

7 General monitoring system requirements .............................................................................................................................11

7.1 General ........................................................................................................................................................................................................11

7.2 Detection range ...................................................................................................................................................................................11

7.3 Detector location ................................................................................................................................................................................12

7.3.1 Background........................................................................................................................................................................12

7.3.2 Ease of accessibility for maintenance .........................................................................................................12

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 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 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 16640:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non­governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 85, Nuclear Energy, Subcommittee SC 2,

Radiological protection.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 16640:2020(E)
Introduction

This document focuses on monitoring the activity concentrations of radioactive gases, from which the

activity releases are calculated, in the gaseous effluent discharge from facilities producing positron

emitting radionuclides and radiopharmaceuticals. Such facilities produce short half­life radionuclides

used for medical purposes or research. These facilities include accelerators, radiopharmacies, hospitals

and universities. This document provides performance­based criteria for the use of air monitoring

equipment including probes, transport lines, sample monitoring instruments, and gas flow measuring

methods. This document also provides information covering monitoring program objectives,

quality assurance, developing air monitoring control action levels, system optimisation, and system

performance verification.

The goal of achieving an accurate measurement of radioactive gases which are well mixed in the

airstream is accomplished either by direct (in-line) measurement on the exhaust stream or by extraction

(bypass) from the exhaust stream for measurement remote from the duct. This document sets forth

performance criteria and recommendations to assist in obtaining valid measurements.

© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 16640:2020(E)
Monitoring radioactive gases in effluents from facilities
producing positron emitting radionuclides and
radiopharmaceuticals
1 Scope

This document focuses on monitoring the activity concentrations of radioactive gases, from which the

activity released are calculated, in the gaseous effluent discharge from facilities producing positron

emitting radionuclides and radiopharmaceuticals. Such facilities produce short half­life radionuclides

used for medical purposes or research and can release gases typically including, but not limited to F,

11 15 13

C, O, N. 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 covering monitoring program objectives, quality assurance,

developing 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 which are extracted (bypass) from the exhaust stream, in which

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 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 normal and off­normal conditions do not include production of aerosols or

vapours. If the normal and/or off­normal conditions produce aerosols and vapours, then the aerosol collection

principles of ISO 2889 also apply.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
abatement equipment

apparatus used to reduce contaminant concentration in the airflow exhausted through a stack or duct

[SOURCE: ISO 2889:2010, 3.1]
© ISO 2020 – All rights reserved 1
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ISO/FDIS 16640:2020(E)
3.2
accident (conditions)

any unintended event, including operating errors, equipment failures and other mishaps, the

consequences or potential consequences of which are not negligible from the point of view of protection

and safety
3.3
accuracy

closeness of agreement between a measured quantity and the true quantity of the measurand

[SOURCE: ISO 2889:2010, 3.4]
3.4
action level

threshold concentration of an effluent contaminant at which an appropriate action is to be performed

[SOURCE: ISO 2889:2010, 3.5]
3.5
aerosol
dispersion of solid or liquid particles in air or other gas
Note 1 to entry: An aerosol is not only the aerosol particles.
[SOURCE: ISO 2889:2010, 3.8]
3.6
analyser

device that provides for near real-time data on radiological characteristics of the gas (air) flow in a

sampling system or duct

Note 1 to entry: Usually, an analyser evaluates the concentration of radionuclides in a sampled air stream;

however, some analysers are mounted directly in or outside a stack or duct.
[SOURCE: ISO 2889:2010, 3.12]
3.7
bend
gradual change in direction of a sample (3.38) transport line
[SOURCE: ISO 2889:2010, 3.14]
3.8
bulk stream
air flow in a stack or duct, as opposed to the sample (3.38) flow rate
[SOURCE: ISO 2889:2010, 3.15]
3.9
bypass system

system whereby a sample (3.38) is withdrawn from the effluent stream and analysed at a location that

is remote from the region where the extraction takes place
3.10
calibration

operation that, under specified conditions, in a first step establishes a relation between the quantity

values with measurement uncertainties provided by measurement standards and corresponding

indications with associated measurement uncertainties and, in a second step, uses this information to

establish a relation for obtaining a measurement result from an indication
2 © ISO 2020 – All rights reserved
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ISO/FDIS 16640:2020(E)
3.11
coefficient of variation

quantity that is the ratio of the standard deviation of a variable to the mean value of that variable

Note 1 to entry: It is usually expressed as a percentage.
[SOURCE: ISO 2889:2010, 3.18]
3.12
continuous air monitor
CAM

near real­time monitor and associated detector(s) which provide data on radionuclides in a sample stream

Note 1 to entry: A CAM is used for monitoring and detecting radioactive gases.
[SOURCE: ISO 2889:2010, 3.21]
3.13
continuous monitoring
continuous near real­time measurements of one or more sampling characteristics
[SOURCE: ISO 2889:2010, 3.22]
3.14
coverage interval

interval containing the set of true quantity values of a measurand with a stated probability, based on

the information available
[SOURCE: ISO 11929­1:2019, 3.4]
3.15
cyclotron

particle accelerator that is commonly used in nuclear medicine to produce positron emitting

radionuclides

Note 1 to entry: Charged particles (e.g. protons or deuterons) are accelerated along a spiral path from the centre

outward to an appropriate target.
3.16
decision threshold

value of the estimator of the measurand, which, when exceeded by the result of an actual measurement

using a given measurement procedure of a measurand quantifying a physical effect, is used to decide

that the physical effect is present

Note 1 to entry: The decision threshold is defined such that in cases where the measurement result exceeds the

decision threshold, the probability of a wrong decision, namely that the true value of the measurand is not zero if

in fact it is zero, is less or equal to a chosen probability α.

Note 2 to entry: If the result is below the decision threshold, it is decided to conclude that the result cannot be

attributed to the physical effect; nevertheless, it cannot be concluded that it is absent

[SOURCE: ISO 11929­1:2019, 3.12]
3.17
detection limit

smallest true value of the measurand which ensures a specified probability of being detectable by the

measurement procedure

Note 1 to entry: With the decision threshold, the detection limit is the smallest true value of the measurand for

which the probability of wrongly deciding that the true value of the measurand is zero is equal to a specified value,

β, when, in fact, the true value of the measurand is not zero. The probability of being detectable is consequently

(1 − β).
© ISO 2020 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO/FDIS 16640:2020(E)
[SOURCE: ISO 11929­1:2019, 3.13]
3.18
effluent
waste stream flowing away from a process, plant, or facility to the environment

Note 1 to entry: In this document, the focus is on effluent air that is discharged to the atmosphere through stacks,

vents and ducts.
[SOURCE: ISO 2889:2010, 3.29]
3.19
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889:2010, 3.30]
3.20
emit
discharge contaminants into the environment
[SOURCE: ISO 2889:2010, 3.31]
3.21
flow rate

rate at which a mass or volume of gas (air) crosses an imaginary cross-sectional area in either a

sampling system tube or a stack or duct

Note 1 to entry: The rate at which the volume crosses the imaginary area is called the volumetric flow rate; and

the rate at which the mass crosses the imaginary area is called either the mass flow rate or the volumetric flow

rate at standard conditions.
[SOURCE: ISO 2889:2010, 3.33]
3.22
hydraulic diameter

type of equivalent duct diameter for ducts that do not have a round cross section

Note 1 to entry: Generally, it is four times the cross-sectional area divided by the perimeter.

[SOURCE: ISO 2889:2010, 3.38]
3.23
in-line system

system where the detector assembly is adjacent to, or immersed in, the effluent (3.18)

3.24
limits of the coverage interval
values which define a coverage interval

Note 1 to entry: It is characterized in this document by a specified probability (1 − γ), e.g., 95 %, and (1 − γ)

represents the probability for the coverage interval of the measurand.

Note 2 to entry: The definition of a coverage interval is ambiguous without further stipulations. In ISO 11929-1

two alternatives, namely the probabilistically symmetric and the shortest coverage interval, are used. In this

document only the probabilistically symmetric is used.

Note 3 to entry: The probabilistically symmetric coverage interval is the coverage interval for a quantity such

that the probability that the quantity is less than the smallest value in the interval is equal to the probability that

the quantity is greater than the largest value in the interval
[SOURCE: ISO 11929­1:2019, 3.16]
4 © ISO 2020 – All rights reserved
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ISO/FDIS 16640:2020(E)
3.25
mixing element

device placed in a stack or duct that is used to augment mixing of both contaminant mass and fluid

[SOURCE: ISO 2889:2010, 3.47]
3.26
monitoring

continual measurement of a quantity (e.g. activity concentration) of the airborne radioactive constituent

or the gross content of radioactive material continuously, at a frequency that permits an evaluation of

the value of that quantity in near real-time, or at intervals that comply with regulatory requirements

[SOURCE: ISO 2889:2010, 3.48]
3.27
normal conditions

limits (or range) of use or operation under which a program or activity is able to meet its objectives and

without significant changes that would impair this ability
3.28
nozzle

device used to extract a sample (3.38) from a stream of the gaseous effluent (3.18) and to transfer the

sample to a transport line or a collector
[SOURCE: ISO 2889:2010, 3.49]
3.29
off-normal conditions
conditions that are unplanned and which present a gap with normal conditions
Note 1 to entry: Examples are accidents and equipment failure.
[SOURCE: ISO 2889:2010, 3.54]
3.30
positron emission tomography
PET

imaging technique that uses radioactive substances to reveal the operating function and metabolism of

tissues and organs, and allows the observation of malignant tissues

Note 1 to entry: The test involves injection of a radioactive drug with the radionuclide being a positron emitter.

Upon annihilation of the positron, two 511 keV photons are produced at 180° angle. These photons are used in

the scanner to determine the point of annihilation and to develop an image.
3.31
probe

sometimes used colloquially to refer to the equipment inserted into a stack or duct for measurement of

volumetric flow or amount of activity present
3.32
profile
distribution of gas velocity over the cross-sectional area of the stack or duct
[SOURCE: ISO 2889:2010, 3.62]
3.33
quality assurance

planned and systematic actions necessary to provide confidence that a system or component performs

satisfactorily in service and that the results are both correct and traceable
[SOURCE: ISO 2889:2010, 3.63]
© ISO 2020 – All rights reserved 5
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ISO/FDIS 16640:2020(E)
3.34
radionuclide

unstable isotope of an element that decays or converts spontaneously into another isotope or different

energy state, emitting radiation
[SOURCE: ISO 2889:2010, 3.64]
3.35
reference method

apparatus and instructions for providing results against which other approaches may be compared

Note 1 to entry: Application of a reference method is assumed to define correct results.

[SOURCE: ISO 2889:2010, 3.66]
3.36
representative sample

sample (3.38) with the same quality and characteristics for the material of interest as that of its source

at the time of sampling
[SOURCE: ISO 2889:2010, 3.67]
3.37
response time

time required after a step variation in the measured quantity for the output signal variation to reach a

given percentage for the first time, usually 90 %, of its final value
[SOURCE: IEC 60761­1:2002, 3.15]
3.38
sample

portion of an air stream of interest, or one or more separated constituents from a portion of an air stream

[SOURCE: ISO 2889:2010, 3.68]
3.39
sample extraction location

location of extraction of a sample (3.38) from the bulk stream (3.8), also known as sampling location

[SOURCE: ISO 2889:2010, 3.69]
3.40
sampling

process of removing a sample (3.38) from the bulk stream (3.8) and transporting it to a monitor

[SOURCE: ISO 2889:2010, 3.72]
3.41
sampling plane
cross sectional area where the sample (3.38) is extracted from the airflow
[SOURCE: ISO 2889:2010, 3.75]
3.42
sampling system

system consisting of an inlet, a transport line, a flow monitoring system and a monitor

[SOURCE: ISO 2889:2010, 3.76]
6 © ISO 2020 – All rights reserved
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ISO/FDIS 16640:2020(E)
3.43
sensitivity

change in indication of a mechanical, nuclear, optical or electronic instrument as affected by changes in

the variable quantity being sensed by the instrument

Note 1 to entry: The slope of a calibration curve of an instrument, where a calibration curve shows output values

of an instrument as a function of input values.
[SOURCE: ISO 2889:2010, 3.78]
3.44
standard conditions
temperature of 25 °C and pressure of 101 325 Pa

Note 1 to entry: Used to convert air densities to a common basis. Other temperature and pressure conditions may

be used and should be applied consistently.
[SOURCE: ISO 2889:2010, 3.82]
3.45
transport line

part of a bypass system (3.9) between the outlet plane of the nozzle (3.28) and the inlet plane of a

detector chamber or a vessel
[SOURCE: ISO 2889:2010, 3.84]
3.46
turbulent flow
flow regime characterized by bulk mixing of fluid properties

Note 1 to entry: For example, in a tube, the flow is turbulent if the Reynolds number is greater than about 3 000

and laminar if the Reynolds number is below about 2 200. There is little mixing in the laminar flow regime.

[SOURCE: ISO 2889:2010, 3.86]
3.47
uncertainty

non-negative parameter characterizing the dispersion of the quantity values being attributed to a

measurand, based on the information used

Note 1 to entry: The analysis of uncertainty is a procedure for estimating the overall impact on the accuracy or

precision of a dependent variable as a result of estimated uncertainties in independent variables.

[SOURCE: ISO 11929­1:2019, 3.10]
3.48
vapour

gaseous form of materials that are liquid or solids at room temperature, as distinguished from

non­condensable gases

Note 1 to entry: Vapours are gases but carry the connotation of having been released or volatilised from liquids

or solids.
[SOURCE: ISO 2889:2010, 3.89]
3.49
velocity profile
distribution of the velocity values at a given cross section in a stack or duct
[SOURCE: ISO 2889:2010, 3.90]
© ISO 2020 – All rights reserved 7
---------------------- Page: 12 ----------------------
ISO/FDIS 16640:2020(E)
4 Symbols
Symbols that are used in formulae in this document are defined below:
A Cross sectional area of the stack or duct, in m ;
A Released activity over a period Δt , in Bq per time;
R R
Decision threshold of the released activity over a period Δt , in Bq per time;
Detection limit of the released activity over a period Δt , in Bq per time;

Lower limit of the coverage interval of the released activity over a period Δt for a given

probability (1 – γ), in Bq per time;

Upper limit of the coverage interval of the released activity over a period Δt for a given

probability (1 – γ), in Bq per time;

C Velocity-averaging correction factor for determining flow rate in a stack or duct from a single

point reading with a pitot tube, dimensionless;
Decision threshold of the activity concentration, in Bq·m ;
Detection limit of the activity concentration, in Bq·m ;

c Gross primary measurement of the activity concentration at a time ti+⋅Δt , in Bq·m ;

g,i 0

Calculated gross average activity concentration over a time interval mt⋅Δ at time ti+⋅mt⋅Δ

mi,m
, in Bq·m ;

Calculated gross average activity concentration over a time interval ΔΔtn=⋅mt⋅ , in Bq m ;

c R
c Activity concentration at a time ti+⋅Δt , in Bq·m ­
i 0
Average value of n number of c , in Bq·m ;
c 0,j
Average value of n number of c , in Bq·m ;
mj, m
0 c

c Gross primary measurement of the activity concentration which represents a background

0,j
situation at a time tj+⋅Δt , in Bq·m ;

Calculated gross average activity concentration over a time interval mt⋅Δ , which represents

mj, m
a background situation at time tj+⋅mt⋅Δ , in Bq·m ;
d Tube diameter, in m;
F Fluctuation constant, dimensionless;

NOTE 1 This is set at 1 for a meter whose readings do not fluctuate. If there are fluctuations,

the parameter is set taken to be the average number of scales unit above and below the mean

indicated value.
I Gross current of the compensating detector at time ti+⋅Δt , in A;
gc,,d i 0
I Gross current of the measuring detector at time ti+⋅Δt , in A;
g,i 0
min
min
Minimum amount of current registered by the measuring detector with I = , in A;
min
8 © ISO 2020 – All rights reserved
---------------------- Page: 1
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 16640
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2020-01-10 2020-04-03
Monitoring radioactive gases in effluents from facilities
producing positron emitting radionuclides and
radiopharmaceuticals
ICS: 13.030.30; 13.280
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16640:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 1 ----------------------
ISO/DIS 16640:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 16640:2019(E)
Contents

Foreword ......................................................................................................................................................................... vi

Introduction.................................................................................................................................................................. vii

1 Scope .................................................................................................................................................................... 1

2 Normative references .................................................................................................................................... 1

3 Terms and definitions.................................................................................................................................... 2

4 Symbols ............................................................................................................................................................ 10

5 Factors impacting the design of the monitoring system ................................................................ 13

6 Types of monitoring systems ................................................................................................................... 13

7 General monitoring system requirements .......................................................................................... 14

7.1 General ............................................................................................................................................................. 14

7.2 Detection range ............................................................................................................................................. 14

7.3 Detector location .......................................................................................................................................... 15

7.3.1 Background .................................................................................................................................................... 15

7.3.2 Ease of accessibility for maintenance ................................................................................................... 15

7.3.3 Environmental conditions ......................................................................................................................... 15

7.4 Emission stream flow measurement ..................................................................................................... 15

8 Requirements specific to bypass systems ........................................................................................... 16

8.1 General ............................................................................................................................................................. 16

8.2 Sample extraction locations ..................................................................................................................... 16

8.3 Condensation ................................................................................................................................................. 17

8.4 Maintenance ................................................................................................................................................... 17

8.5 Leak checks ..................................................................................................................................................... 17

9 Requirements specific to in-line systems ............................................................................................ 17

9.1 General ............................................................................................................................................................. 17

9.2 Location of the probe or detector ........................................................................................................... 18

9.3 Environmental conditions ......................................................................................................................... 18

10 Evaluation and upgrading of existing systems .................................................................................. 18

11 Quality assurance and quality control .................................................................................................. 19

(informative) Factors impacting monitoring system design.................................................... 20

A.1 Introduction ................................................................................................................................................... 20

A.2 The monitoring purpose ............................................................................................................................ 22

A.3 Considerations for different monitoring conditions ....................................................................... 22

A.3.1 General ............................................................................................................................................................. 22

A.3.2 Monitoring under a normal condition .................................................................................................. 23

A.3.3 Monitoring under an off-normal condition ......................................................................................... 23

A.3.4 Action levels ................................................................................................................................................... 23

A.4 Considerations for different monitoring systems ............................................................................ 25

A.4.1 In-line monitoring system ......................................................................................................................... 25

A.4.2 Bypass monitoring system ........................................................................................................................ 26

A.4.3 Environment of the monitoring system ............................................................................................... 28

A.4.4 Characteristics of the monitoring system ............................................................................................ 32

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ISO/DIS 16640:2019(E)

(informative) Evaluating uncertainty of effluent measurement ............................................ 35

B.1 Introduction ................................................................................................................................................... 35

B.2 Description of real-time measurement systems ............................................................................... 35

B.2.1 General Description ..................................................................................................................................... 35

B.2.2 Real-time activity concentration ............................................................................................................ 38

B.3 Determination of released activity ........................................................................................................ 40

B.3.1 Definition of the model of evaluation ................................................................................................... 40

B.3.2 Standard uncertainty .................................................................................................................................. 41

B.3.3 Decision threshold and detection limit ................................................................................................ 42

B.3.4 Limits of the coverage interval ................................................................................................................ 43

B.4 Application examples.................................................................................................................................. 43

B.4.1 Description of the measurement equipment and its display and archiving principles ..... 43

B.4.2 Released activity characteristic limits and results .......................................................................... 44

(informative) Quality assurance ......................................................................................................... 47

C.1 Introduction ................................................................................................................................................... 47

C.2 Documentation .............................................................................................................................................. 47

C.2.1 General ............................................................................................................................................................. 47

C.2.2 Source term .................................................................................................................................................... 47

C.2.3 Effluent flow characterization ................................................................................................................. 47

C.2.4 Design and construction ............................................................................................................................ 47

C.3 Maintenance and inspection .................................................................................................................... 48

C.3.1 General ............................................................................................................................................................. 48

C.3.2 Inspections ...................................................................................................................................................... 48

C.3.3 Sampling system flow meter inspections ............................................................................................ 49

C.3.4 Continuous effluent flow measurement apparatus ......................................................................... 49

C.4 Calibration Verification .............................................................................................................................. 50

C.4.1 General ............................................................................................................................................................. 50

C.4.2 Calibration of sampling system flow meters ...................................................................................... 50

C.4.3 Calibration of effluent flow measurement devices .......................................................................... 50

C.4.4 Calibration of timing devices ................................................................................................................... 50

C.4.5 Calibration verification of the radioactivity measurement devices .......................................... 51

(informative) Mixing demonstration and sampling system performance

verification ...................................................................................................................................................... 52

D.1 Mixing demonstration methods .............................................................................................................. 52

D.1.1 General ............................................................................................................................................................. 52

D.1.2 Gas concentration mixing profile method ........................................................................................... 52

D.1.3 Alternate approaches to demonstrating mixing ............................................................................... 54

D.2 When to conduct sampling system performance verification ..................................................... 54

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D.3 Approaches to bypass sample line verification ................................................................................. 55

D.3.1 General ............................................................................................................................................................. 55

D.3.2 In-Place sampling examples ..................................................................................................................... 55

D.3.3 Laboratory simulations .............................................................................................................................. 55

D.3.4 Modelling sample line deposition .......................................................................................................... 55

(informative) Techniques for measurement of flow rate through a stack or duct ........... 56

E.1 Introduction ................................................................................................................................................... 56

E.2 Special considerations for use of ISO 10780 in sampling stacks and ducts of the

positron gas emitting facilities ................................................................................................................ 56

E.2.1 General ............................................................................................................................................................. 56

E.2.2 Pitot tubes ....................................................................................................................................................... 57

E.2.3 Mean molar mass of the stack gas .......................................................................................................... 57

E.2.4 Thermal anemometers and acoustic flowmeters ............................................................................. 57

E.3 Conversion of data from single point or single line measurements to total flow rate ........ 57

E.3.1 General ............................................................................................................................................................. 57

E.3.2 Pitot tube ......................................................................................................................................................... 57

Bibliography ................................................................................................................................................................. 59

© ISO 2019 – All rights reserved v
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ISO/DIS 16640:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any

patent rights identified during the development of the document will be in the Introduction and/or on

the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the World

Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 85, Nuclear Energy, Subcommittee SC 2,

Radiological protection.
vi © ISO 2019 – All rights reserved
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ISO/DIS 16640:2019(E)
Introduction

This document focuses on monitoring the activity concentrations of radioactive gases, from which the

activity released are calculated, in the gaseous effluent discharge from facilities producing positron

emitting radionuclides and radiopharmaceuticals. Such facilities produce short half-life radionuclides

used for medical purposes or research. These facilities include accelerators, radiopharmacies, hospitals

and universities. This document provides performance-based criteria for the use of air monitoring

equipment including probes, transport lines, sample monitoring instruments, and gas flow measuring

methods. This document also provides information covering monitoring program objectives, quality

assurance, developing air monitoring control action levels, system optimisation, and system performance

verification.

The goal of achieving an accurate measurement of radioactive gases which are well mixed in the

airstream is accomplished either by direct (in-line) measurement on the exhaust stream or by extraction

(bypass) from the exhaust stream for measurement remote from the duct. This document sets forth

performance criteria and recommendations to assist in obtaining valid measurements.

© ISO 2019 – All rights reserved vii
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ISO/DIS 16640:2019(E)
Monitoring radioactive gases in effluents from facilities producing
positron emitting radionuclides and radiopharmaceuticals
1 Scope

This document focuses on monitoring the activity concentrations of radioactive gases, from which the

activity released are calculated, in the gaseous effluent discharge from facilities producing positron

emitting radionuclides and radiopharmaceuticals. Such facilities produce short half-life radionuclides

used for medical purposes or research and may release gases typically including, but not limited to F,

11 15 13

C, O, N. 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 covering monitoring program objectives, quality assurance,

developing 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 which are extracted (bypass) from the exhaust stream, in which

the radioactive gases are well mixed in the airstream. This document sets forth performance criteria and

recommendations to assist in obtaining valid measurements.

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 to the

performance criteria and recommendations of this document, an evaluation of the performance of the

system is advised. If deficiencies are discovered, it should be determined if retrofit is needed and

practicable.

The criteria and recommendations of this document apply under both normal and off-normal operating

conditions, provided that normal and off-normal 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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

IEC 60761-1:2002, Equipment for continuous monitoring of radioactivity in gaseous effluents —

Part 1: General requirements

ISO 10780:1994, Stationary source emissions — Measurement of velocity and volume flowrate of gas

streams in ducts

ISO 11929-1:2019, Determination of the characteristic limits (decision threshold, detection limit and limits

of the coverage interval) for measurements of ionizing radiation — Fundamentals and application —

Part 1: Elementary applications

ISO 2889:2010, Sampling airborne radioactive materials from the stacks and ducts of nuclear facilities

ISO/IEC Guide 98-3 uncertainty of measurement, Part 3: Guide to the expression of uncertainty in

measurement ( GUM:1995)
© ISO 2019 – All rights reserved 1
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ISO/DIS 16640:2019(E)

ISO/DTR 22930-2:2019: Determination of a real-time monitoring system performance of the activity

concentration of radioactive substances in the air — Part 2: Air monitors based on circulating sampling

techniques without accumulation

ISO/IEC Guide 98-3-1:2008, Evaluation of measurement data — Supplement 1 to the “Guide to the

expression of uncertainty in measurement” — Propagation of distributions using a Monte Carlo method,

(JGCM 101:2008)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
abatement equipment

apparatus used to reduce contaminant concentration in the airflow exhausted through a stack or duct

[SOURCE: ISO 2889, 3.1]
3.2
absorbent

material that takes up a constituent through the action of diffusion, allowing the constituent to

penetrate into the structure of the absorbent (if a solid) or dissolve in it (if a liquid)

Note 1 to entry: When chemical reaction takes place during absorption, the process is called chemisorption.

[SOURCE: ISO 2889, 3.2]
3.3
accident (conditions)

upset conditions that can lead to the release of abnormal amounts of radionuclides

[SOURCE: ISO 2889, 3.3]
3.4
accuracy

closeness of agreement between a measured quantity and the true quantity of the measurand

[SOURCE: ISO 2889, 3.4]
3.5
action level

threshold concentration of an effluent contaminant at which an appropriate action is to be performed

[SOURCE: ISO 2889, 3.5]
3.6
adsorbent

material, generally a solid, which retains a substance contacting it through short range molecular forces

that bind the adsorbed material at the surface of the material
2 © ISO 2019 – All rights reserved
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ISO/DIS 16640:2019(E)
[SOURCE: ISO 2889, 3.6]
3.7
aerosol
dispersion of solid or liquid particles in air or other gas
Note 1 to entry: An aerosol is not only the aerosol particles.
[SOURCE: ISO 2889, 3.8]
3.8
analyser

device that provides for near real-time data on radiological characteristics of the gas (air) flow in a

sampling system or duct

Note 1 to entry: Usually, an analyser evaluates the concentration of radionuclides in a sampled air stream; however,

some analysers are mounted directly in or outside a stack or duct.
[SOURCE: ISO 2889, 3.12]
3.9
bend
gradual change in direction of a sample transport line
[SOURCE: ISO 2889, 3.13]
3.10
bulk stream
air flow in a stack or duct, as opposed to the sample flow rate
[SOURCE: ISO 2889, 3.15]
3.11
bypass system

system whereby a sample is withdrawn from the effluent stream and analyzed at a location that is remote

from the region where the extraction takes place
3.12
calibration

operation that, under specified conditions, in a first step establishes a relation between the quantity

values with measurement uncertainties provided by measurement standards and corresponding

indications with associated measurement uncertainties and, in a second step, uses this information to

establish a relation for obtaining a measurement result from an indication
3.13
coefficient of variation
COV

quantity that is the ratio of the standard deviation of a variable to the mean value of that variable

Note 1 to entry: It is usually expressed as a percentage.
[SOURCE: ISO 2889, 3.18]
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ISO/DIS 16640:2019(E)
3.14
conditioning system

apparatus that could be used to purposefully to control sample temperature, pressure, dilution or other

properties
[SOURCE: ISO 2889, 3.20]
3.15
continuous air monitor
CAM

near real-time monitor and associated detector(s) which provide data on radionuclides in a sample

stream
[SOURCE: ISO 2889, 3.21]
3.16
continuous monitoring
continuous near real-time measurements of one or more sampling characteristics
[SOURCE: ISO 2889, 3.22]
3.17
cyclotron

particle accelerator commonly used to produce positron emitting radionuclides by accelerating protons

or deuterons into a suitable target
3.18
decision threshold

value of the estimator of the measurand, which, when exceeded by the result of an actual measurement

using a given measurement procedure of a measurand quantifying a physical effect, is used to decide that

the physical effect is present

Note 1 to entry: The decision threshold is defined such that in cases where the measurement result exceeds the

decision threshold, the probability of a wrong decision, namely that the true value of the measurand is not zero if in

fact it is zero, is less or equal to a chosen probability α.
[SOURCE: ISO 11929-1, 3.12]
3.19
detection limit

smallest true value of the measurand which ensures a specified probability of being detectable by the

measurement procedure

Note 1 to entry: With the decision threshold, the detection limit is the smallest true value of the measurand for

which the probability of wrongly deciding that the true value of the measurand is zero is equal to a specified value,

β, when, in fact, the true value of the measurand is not zero. The probability of being detectable is consequently (1-

β).
[SOURCE: ISO 11929, 3.13]
3.20
effective dose

sum of the products of the dose absorbed to an organ or a tissue and the weighting factors relative to the

radiation and to the organs or tissues that are irradiated
[SOURCE: ISO 2889, 3.28]
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ISO/DIS 16640:2019(E)
3.21
effluent
waste stream flowing away from a process, plant, or facility to the environment

Note 1 to entry: In this document, the focus is on effluent air that is discharged to the atmosphere through stacks,

vents and ducts.
[SOURCE: ISO 2889, 3.29]
3.22
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889, 3.30]
3.23
emit
discharge contaminants into the environment
[SOURCE: ISO 2889, 3.31]
3.24
flow rate

rate at which mass or volume of gas (air) crosses an imaginary cross sectional area in eithe

...

PROJET DE NORME INTERNATIONALE
ISO/DIS 16640
ISO/TC 85/SC 2 Secrétariat: AFNOR
Début de vote: Vote clos le:
2020-01-10 2020-04-03
Surveillance des gaz radioactifs dans les effluents des
installations produisant des radionucléides et des produits
radiopharmaceutiques émetteurs de positrons

Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and

radiopharmaceuticals
ICS: 13.030.30; 13.280
CE DOCUMENT EST UN PROJET DIFFUSÉ POUR
OBSERVATIONS ET APPROBATION. IL EST DONC
SUSCEPTIBLE DE MODIFICATION ET NE PEUT
ÊTRE CITÉ COMME NORME INTERNATIONALE
AVANT SA PUBLICATION EN TANT QUE TELLE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE

Le présent document est distribué tel qu’il est parvenu du secrétariat du comité.

DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
Numéro de référence
LES DESTINATAIRES DU PRÉSENT PROJET
ISO/DIS 16640:2020(F)
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE. ISO 2020
---------------------- Page: 1 ----------------------
ISO/DIS 16640:2020(F)
ISO/DIS 16640:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................. vi

Introduction .................................................................................................................................................................. vii

1 Domaine d’application ...................................................................................................................................1

2 Références normatives ..................................................................................................................................1

3 Termes et définitions .....................................................................................................................................2

4 Symboles .......................................................................................................................................................... 10

5 Facteurs influant sur la conception du système de surveillance ................................................ 13

6 Types de systèmes de surveillance ........................................................................................................ 14

7 Exigences générales applicables aux systèmes de surveillance .................................................. 14

7.1 Généralités ...................................................................................................................................................... 14

7.2 Plage de détection ........................................................................................................................................ 15

7.3 Emplacement du détecteur ....................................................................................................................... 15

7.3.1 Contexte ........................................................................................................................................................... 15

7.3.2 Facilité d’accès pour la maintenance ..................................................................................................... 16

7.3.3 Conditions environnementales ............................................................................................................... 16

7.4 Mesurage du débit des rejets.................................................................................................................... 16

8 Exigences spécifiques aux systèmes en dérivation .......................................................................... 16

8.1 Généralités ...................................................................................................................................................... 16

8.2 Points d’extraction des échantillons...................................................................................................... 16

8.3 Condensation.................................................................................................................................................. 18

8.4 Maintenance ................................................................................................................................................... 18

8.5 Contrôles d’étanchéité ................................................................................................................................ 18

9 Exigences spécifiques aux systèmes en ligne ..................................................................................... 18

9.1 Généralités ...................................................................................................................................................... 18

9.2 Emplacement de la sonde ou du détecteur.......................................................................................... 18

9.3 Conditions environnementales ............................................................................................................... 19

10 Évaluation et mise à niveau des systèmes existants ........................................................................ 19

11 Assurance qualité et contrôle qualité ................................................................................................... 20

Annexe A (informative) Facteurs ayant un impact sur la conception du système de

surveillance .................................................................................................................................................... 21

A.1 Introduction.................................................................................................................................................... 21

A.2 Objectif de la surveillance ......................................................................................................................... 23

A.3 Facteurs à considérer pour les différentes conditions de surveillance .................................... 23

A.3.1 Généralités ...................................................................................................................................................... 23

DOCUMENT PROTÉGÉ PAR COPYRIGHT

A.3.2 Surveillance en conditions normales .................................................................................................... 24

© ISO 2020

A.3.3 Surveillance en conditions anormales .................................................................................................. 24

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en oeuvre, aucune partie de cette

A.3.4 Niveaux d’action ............................................................................................................................................ 24

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

A.4 Facteurs à considérer pour les différents systèmes de surveillance ......................................... 26

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

A.4.1 Système de surveillance en ligne ............................................................................................................ 26

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

A.4.2 Système de surveillance en dérivation ................................................................................................. 27

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8

A.4.3 Environnement du système de surveillance ....................................................................................... 29

CH-1214 Vernier, Geneva

A.4.4 Caractéristiques du système de surveillance ..................................................................................... 33

Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47

Annexe B (informative) Évaluation de l’incertitude du mesurage des effluents .................................. 36

E-mail: copyright@iso.org
Website: www.iso.org
© ISO 2020 – Tous droits réservés
iii
Publié en Suisse
ii © ISO 2020 – Tous droits réservés
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ISO/DIS 16640:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................. vi

Introduction .................................................................................................................................................................. vii

1 Domaine d’application ...................................................................................................................................1

2 Références normatives ..................................................................................................................................1

3 Termes et définitions .....................................................................................................................................2

4 Symboles .......................................................................................................................................................... 10

5 Facteurs influant sur la conception du système de surveillance ................................................ 13

6 Types de systèmes de surveillance ........................................................................................................ 14

7 Exigences générales applicables aux systèmes de surveillance .................................................. 14

7.1 Généralités ...................................................................................................................................................... 14

7.2 Plage de détection ........................................................................................................................................ 15

7.3 Emplacement du détecteur ....................................................................................................................... 15

7.3.1 Contexte ........................................................................................................................................................... 15

7.3.2 Facilité d’accès pour la maintenance ..................................................................................................... 16

7.3.3 Conditions environnementales ............................................................................................................... 16

7.4 Mesurage du débit des rejets.................................................................................................................... 16

8 Exigences spécifiques aux systèmes en dérivation .......................................................................... 16

8.1 Généralités ...................................................................................................................................................... 16

8.2 Points d’extraction des échantillons...................................................................................................... 16

8.3 Condensation.................................................................................................................................................. 18

8.4 Maintenance ................................................................................................................................................... 18

8.5 Contrôles d’étanchéité ................................................................................................................................ 18

9 Exigences spécifiques aux systèmes en ligne ..................................................................................... 18

9.1 Généralités ...................................................................................................................................................... 18

9.2 Emplacement de la sonde ou du détecteur.......................................................................................... 18

9.3 Conditions environnementales ............................................................................................................... 19

10 Évaluation et mise à niveau des systèmes existants ........................................................................ 19

11 Assurance qualité et contrôle qualité ................................................................................................... 20

Annexe A (informative) Facteurs ayant un impact sur la conception du système de

surveillance .................................................................................................................................................... 21

A.1 Introduction.................................................................................................................................................... 21

A.2 Objectif de la surveillance ......................................................................................................................... 23

A.3 Facteurs à considérer pour les différentes conditions de surveillance .................................... 23

A.3.1 Généralités ...................................................................................................................................................... 23

A.3.2 Surveillance en conditions normales .................................................................................................... 24

A.3.3 Surveillance en conditions anormales .................................................................................................. 24

A.3.4 Niveaux d’action ............................................................................................................................................ 24

A.4 Facteurs à considérer pour les différents systèmes de surveillance ......................................... 26

A.4.1 Système de surveillance en ligne ............................................................................................................ 26

A.4.2 Système de surveillance en dérivation ................................................................................................. 27

A.4.3 Environnement du système de surveillance ....................................................................................... 29

A.4.4 Caractéristiques du système de surveillance ..................................................................................... 33

Annexe B (informative) Évaluation de l’incertitude du mesurage des effluents .................................. 36

© ISO 2020 – Tous droits réservés
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ISO/DIS 16640:2020(F)

B.1 Introduction ................................................................................................................................................... 36

B.2 Description des systèmes de mesure en temps réel ........................................................................ 36

B.2.1 Description générale ................................................................................................................................... 36

B.2.2 Activité volumique en temps réel .......................................................................................................... 39

B.3 Détermination de l’activité rejetée ........................................................................................................ 42

B.3.1 Définition du modèle d’évaluation ........................................................................................................ 42

B.3.2 Incertitude-type ............................................................................................................................................ 42

B.3.3 Seuil de décision et limite de détection................................................................................................ 43

B.3.4 Limites de l’intervalle élargi .................................................................................................................... 44

B.4 Exemples d’application .............................................................................................................................. 45

B.4.1 Description de l’équipement de mesure et de ses principes d’affichage et d’archivage .... 45

B.4.2 Limites caractéristiques de l’activité rejetée et résultats ............................................................. 45

Annexe C (informative) Assurance qualité ........................................................................................................ 48

C.1 Introduction ................................................................................................................................................... 48

C.2 Documentation .............................................................................................................................................. 48

C.2.1 Généralités...................................................................................................................................................... 48

C.2.2 Terme source ................................................................................................................................................. 48

C.2.3 Caractérisation d’un écoulement d’effluents ..................................................................................... 48

C.2.4 Conception et construction ....................................................................................................................... 48

C.3 Maintenance et inspection ........................................................................................................................ 49

C.3.1 Généralités...................................................................................................................................................... 49

C.3.2 Inspections ..................................................................................................................................................... 49

C.3.3 Inspections du débitmètre du système de prélèvement ................................................................ 50

C.3.4 Appareil de mesurage en continu de l’écoulement d’effluents ................................................... 50

C.4 Vérification de l’étalonnage ..................................................................................................................... 51

C.4.1 Généralités...................................................................................................................................................... 51

C.4.2 Étalonnage des débitmètres du système de prélèvement ............................................................. 51

C.4.3 Étalonnage des dispositifs de mesurage de l’écoulement d’effluents ....................................... 52

C.4.4 Étalonnage des minuteurs ........................................................................................................................ 52

C.4.5 Vérification de l’étalonnage des dispositifs de mesure de radioactivité ................................. 52

Annexe D (informative) Démonstration de mélange et vérification des performances du

système de prélèvement ............................................................................................................................ 53

D.1 Méthodes de démonstration de mélange ............................................................................................ 53

D.1.1 Généralités...................................................................................................................................................... 53

D.1.2 Méthode du profil de mélange des concentrations de gaz ............................................................ 53

D.1.3 Autres approches pour démontrer le mélange ................................................................................. 55

D.2 Quand vérifier les performances du système de prélèvement ? ................................................. 56

D.3 Approche de vérification d’une ligne de prélèvement en dérivation ....................................... 56

D.3.1 Généralités...................................................................................................................................................... 56

D.3.2 Exemples de prélèvement in situ ........................................................................................................... 56

D.3.3 Simulations en laboratoire ....................................................................................................................... 56

D.3.4 Modélisation du dépôt en ligne des échantillons ............................................................................. 57

Annexe E (informative) Techniques de mesure de débit dans un émissaire de rejet ou un

conduit ............................................................................................................................................................. 58

E.1 Introduction ................................................................................................................................................... 58

E.2 Considérations particulières relatives à l’utilisation de l’ISO 10780 dans les conduits

et émissaires de rejet de prélèvement des installations produisant des effluents

gazeux émetteurs de positrons ............................................................................................................... 58

E.2.1 Généralités...................................................................................................................................................... 58

E.2.2 Tubes de Pitot ................................................................................................................................................ 59

E.2.3 Masse molaire moyenne du gaz dans un émissaire de rejet ........................................................ 59

E.2.4 Anémomètres thermiques et débitmètres acoustiques ................................................................. 59

© ISO 2020 – Tous droits réservés
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ISO/DIS 16640:2020(F)

E.3 Conversion des données obtenues à partir de mesurages réalisés en un seul point ou

sur une seule ligne en débit total ............................................................................................................ 59

E.3.1 Généralités ...................................................................................................................................................... 59

E.3.2 Tube de Pitot .................................................................................................................................................. 59

Bibliographie ................................................................................................................................................................ 61

© ISO 2020 – Tous droits réservés
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ISO/DIS 16640:2020(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le

droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d’approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2

(voir www.iso.org/directives).

L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de

droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les

références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www.iso.org/brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant : www.iso.org/iso/fr/avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 85, Énergie nucléaire, technologies

nucléaires, et radioprotection, sous-comité SC 2, Radioprotection.
© ISO 2020 – Tous droits réservés
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ISO/DIS 16640:2020(F)
Introduction

Le présent document porte sur la surveillance de l’activité volumique des gaz radioactifs, à partir de

laquelle sont calculés les 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 utilisés à des fins médicales et de

recherche. Ces installations comprennent les accélérateurs, les radiopharmacies, les hôpitaux et les

universités. Le présent document spécifie des critères de performance pour 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 du 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 précis des gaz radioactifs, mélangés de façon homogène dans le flux

d’air, est atteint soit par un mesurage direct (en ligne) sur le flux de rejets, soit par une extraction du

flux de rejets en vue d’un mesurage déporté (système en dérivation) du conduit. Le présent document

fournit des critères de performance et des recommandations destinées à faciliter la réalisation de

mesurages valides.
© ISO 2020 – Tous droits réservés
vii
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PROJET DE NORME INTERNATIONALE ISO/DIS 16640:2020(F)
Surveillance des gaz radioactifs dans les effluents des
installations produisant des radionucléides et des produits
radiopharmaceutiques émetteurs de positrons
1 Domaine d’application

Le présent document porte sur la surveillance de la concentration volumique des gaz radioactifs, à

partir de laquelle sont calculés les 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

18 11 15 13

de recherche, et peuvent libérer des gaz incluant généralement, mais sans s’y limiter, F, C, O, N.

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 (en dérivation) d’échantillons du flux de rejets, les gaz radioactifs étant

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.

Les critères et les recommandations du présent document concerne
...

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