SIST EN ISO 16637:2019

SLOVENSKI STANDARD
oSIST prEN ISO 16637:2019
01-januar-2019
5DGLRORãND]DãþLWD1DG]RURYDQMHLQQRWUDQMDGR]LPHWULMD]DþODQHRVHEMD
L]SRVWDYOMHQHPHGLFLQVNLPUDGLRQXNOLGRPNRWRGSUWHPXYLUXVHYDQMD,62

Radiological protection - Monitoring and internal dosimetry for staff members exposed to
medical radionuclides as unsealed sources (ISO 16637:2016)
Strahlenschutz - Überwachung und interne Dosimetrie für Personal, das durch
medizinische Radionuklide aus offenen Quellen exponiert wurde (ISO 16637:2016)
Radioprotection - Surveillance et dosimétrie interne des travailleurs exposés lors des
utilisations médicales des radioéléments en sources non scellées (ISO 16637:2016)
Ta slovenski standard je istoveten z: prEN ISO 16637
ICS:
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN ISO 16637:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 16637:2019

---------------------- Page: 2 ----------------------
oSIST prEN ISO 16637:2019
INTERNATIONAL ISO
STANDARD 16637
First edition
2016-02-15
Radiological protection — Monitoring
and internal dosimetry for staff
members exposed to medical
radionuclides as unsealed sources
Radioprotection — Surveillance et dosimétrie interne des travailleurs
exposés lors des utilisations médicales des radioéléments en sources
non scellées
Reference number
ISO 16637:2016(E)
©
ISO 2016

---------------------- Page: 3 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 5
5 Purpose and need for monitoring programmes in nuclear medical diagnosis and therapy 6
5.1 General . 6
5.2 Assessment of the level of likely exposures . 6
5.3 Monitoring programmes . 7
5.3.1 General. 7
5.3.2 Confirmatory monitoring programmes . 7
5.3.3 Routine monitoring programmes. 8
5.3.4 Triage monitoring programmes . 8
5.3.5 Task-related monitoring programmes . 8
5.3.6 Special monitoring programmes . 8
5.3.7 Implementation of a monitoring programme. 9
6 Common radionuclides .10
7 Reference levels .10
8 Routine monitoring programmes .11
8.1 General aspects .11
8.2 Individual monitoring .12
8.3 Methods and monitoring intervals .12
9 Triage monitoring programmes .13
10 Special Monitoring programmes .13
10.1 General aspects .13
10.2 Workplace monitoring . .14
10.3 Individual monitoring .14
11 Confirmatory monitoring programmes .15
11.1 General aspects .15
11.2 Workplace monitoring . .15
11.3 Individual monitoring .15
12 Measurement techniques and performance criteria .15
12.1 General .15
12.2 Measurements performed in a laboratory specialised for radiobioassay .16
12.2.1 In vitro.16
12.2.2 In vivo .16
12.2.3 Quality assurance and quality control for bioassay laboratories .16
12.3 Measurements performed in nuclear medicine service .17
13 Procedure for the assessment of exposures .17
13.1 Interpretation of individual monitoring data for dose assessment .17
13.1.1 General.17
13.1.2 Dose assessment based on routine monitoring .17
13.1.3 Dose assessment based on special monitoring .17
13.2 Software tools .22
13.3 Uncertainties .22
13.4 Quality assurance of the assessment process .22
14 Reporting and documentation .23
© ISO 2016 – All rights reserved iii

---------------------- Page: 5 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

14.1 Reporting results for in vitro measurements .23
14.2 Reporting results for in vivo measurements .23
14.3 Documentation of the dose assessment .24
Annex A (informative) IAEA Safety Guide RS-G-1.2 “decision factor” .25
Bibliography .27
iv © ISO 2016 – All rights reserved

---------------------- Page: 6 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
© ISO 2016 – All rights reserved v

---------------------- Page: 7 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

Introduction
In the course of employment, individuals might work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against risks of incorporated
radionuclides requires the monitoring of potential intakes and/or the quantification of actual intakes
and exposures. The doses resulting from internal radiation exposure arising from contamination
by radioactive substances cannot be measured directly. The selection of measures and programmes
for this purpose requires decisions concerning methods, techniques, frequencies, etc. for activity
measurements and dose assessment. The criteria permitting the evaluation of the necessity of such a
monitoring programme or for the selection of methods and frequencies of monitoring usually depend
upon the legislation, the purpose of the radiation protection programme, the probabilities of potential
radionuclide intakes, and the characteristics of the materials handled.
For these reasons, ISO standards establishing requirements for monitoring programmes (ISO 20553),
laboratory requirements (ISO 28218), and dose assessment (ISO 27048) have been developed. These can
be applied in a straightforward manner to many workplaces where internal contamination may occur.
In order to apply these standards to staff involved in diagnostic or therapeutic uses of radionuclides
in medicine, the short effective half-life of radionuclides commonly used for these purposes and the
distance between nuclear medicine department and in vivo counting facilities or radio-analytical
laboratories shall be taken into account. Consequently, guidance on the application of the three
International Standards cited above to nuclear medicine staff was requested by a number of countries.
This International Standard establishes criteria to determine whether intake monitoring is required
for staff exposed to medical radionuclides as unsealed sources. It also establishes requirements on the
design of such monitoring programmes, associated dose assessments, and laboratory requirements.
Recommendations of international expert bodies and international experience with the practical
application of these recommendations in radiological protection programmes have been considered in
the development of this International Standard. Its application facilitates the exchange of information
between authorities, supervisory institutions, and employers. This International Standard is not a
substitute for legal requirements.
vi © ISO 2016 – All rights reserved

---------------------- Page: 8 ----------------------
oSIST prEN ISO 16637:2019
INTERNATIONAL STANDARD ISO 16637:2016(E)
Radiological protection — Monitoring and internal
dosimetry for staff members exposed to medical
radionuclides as unsealed sources
1 Scope
This International Standard specifies the minimum requirements for the design of professional
programmes to monitor workers exposed to the risk of internal contamination via inhalation by
the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments.
It establishes principles for the development of compatible goals and requirements for monitoring
programmes and, when adequate, dose assessment. It presents procedures and assumptions for the risk
analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data.
This International Standard addresses the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) quantitative criteria for conducting monitoring programmes;
d) suitable methods for monitoring and criteria for their selection;
e) information that has to be collected for the design of a monitoring programme;
f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);
g) frequencies of measurements;
h) procedures for dose assessment based on reference levels for routine and special monitoring
programmes;
i) assumptions for the selection of dose-critical parameter values;
j) criteria for determining the significance of individual monitoring results;
k) interpretation of workplace monitoring results;
l) uncertainties arising from dose assessments and interpretation of bioassays data;
m) reporting/documentation;
n) quality assurance.
This International Standard does not address the following:
— monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such
as radioimmunoassay techniques;
— monitoring and internal dosimetry for the workers involved in the operation, maintenance, and
servicing of PET cyclotrons;
— detailed descriptions of measuring methods and techniques;
— dosimetry for litigation cases;
— modelling for the improvement of internal dosimetry;
© ISO 2016 – All rights reserved 1

---------------------- Page: 9 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

— the potential influence of medical treatment of the internal contamination;
— the investigation of the causes or implications of an exposure;
— dosimetry for ingestion exposures and for contaminated wounds.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 20553, Radiation protection — Monitoring of workers occupationally exposed to a risk of internal
contamination with radioactive material
ISO 27048:2011, Radiation protection — Dose assessment for the monitoring of workers for internal
radiation exposure
ISO 28218, Radiation protection — Performance criteria for radiobioassay
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 20553,
ISO 28218 and ISO 27048 and the following apply.
3.1
absorption
movement of material to blood regardless of mechanism, generally applied to dissociation of particles
and uptake into blood of soluble substances and material dissociated from particles
3.2
absorption type F
as defined by ICRP, deposited materials that have high (fast) rates of absorption (3.1) into body fluids
from the respiratory tract
3.3
absorption type M
as defined by ICRP, deposited materials that have intermediate (moderate) rates of absorption (3.1) into
body fluids from the respiratory tract
3.4
activity
number of spontaneous nuclear transformations per unit time
Note 1 to entry: The activity is stated in becquerel (Bq), i.e. the number of transformations per second.
3.5
activity median aerodynamic diameter
AMAD
value of aerodynamic diameter such that 50 % of the airborne activity (3.4) in a specified aerosol is
associated with particles smaller than the AMAD, and 50 % of the activity is associated with particles
larger than the AMAD
Note 1 to entry: The aerodynamic diameter of an airborne particle is the diameter that a sphere of unit density
would need to have in order to have the same terminal velocity when settling in air as the particle of interest.
2 © ISO 2016 – All rights reserved

---------------------- Page: 10 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

3.6
contamination
activity (3.4) of radionuclides present on surfaces, or within solids, liquids or gases (including the
human body), where the presence of such radioactive material is unintended or undesirable
3.7
decision threshold
fixed value of the measurand by which, when exceeded by the result of an actual measurement of a
measurand quantifying a physical effect, it is decided that the physical effect is present
3.8
detection limit
smallest true value of the measurand which is detectable by the measuring method
3.9
annual dose
committed effective dose (3.11) resulting from all intakes (3.14) occurring during a calendar year
Note 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding
intakes.
3.10
committed equivalent dose
sum of the products of the total doses absorbed by an organ or a tissue from radiation types, integrated
over the commitment period following the intake (3.14) of a radionuclide, and the appropriate radiation
weighting factors
3.11
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue
weighting factors
Note 1 to entry: In the context of this International Standard, the commitment period [integration time following
the intake (3.14)] is taken to be 50 years.
3.12
excretion function
function describing the fraction of an intake (3.14) excreted per day after a given time has elapsed since
the intake occurred
3.13
event = incident
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not negligible from the point of view of protection
or safety
3.14
intake
activity (3.4) of a radionuclide taken into the body in a given time period or as a result of a given event
3.15
in vitro analyses
indirect measurements
analyses including measurements of radioactivity present in biological samples taken from an
individual
Note 1 to entry: These include urine, faeces, and nasal samples; in special monitoring programmes (3.21), samples
of other materials, such as blood and hair, may be taken.
© ISO 2016 – All rights reserved 3

---------------------- Page: 11 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

3.16
in vivo measurements
direct measurements
measurement of radioactivity present in the human body, carried out using detectors to measure the
radiation emitted
Note 1 to entry: Normally, the measurement devices are whole-body or partial-body (e.g. lung, thyroid) counters.
3.17
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results
Note 1 to entry: This International Standard distinguishes five different categories of monitoring programmes,
namely, routine monitoring programme (3.18), task-related monitoring programme (3.19), triage monitoring
programme (3.20), special monitoring programme (3.21), and confirmatory monitoring programme (3.22).
Note 2 to entry: This International Standard distinguishes two different types of monitoring, namely, individual
monitoring (3.23) and workplace monitoring (3.24).
3.18
routine monitoring programme
monitoring programme associated with continuing operations and intended to demonstrate that
working conditions, including the levels of individual dose, remain satisfactory, and to meet regulatory
requirements
3.19
task-related monitoring programme
monitoring programme related to a specific operation, to provide information on a specific operation of
limited duration, or following major modifications applied to the installations or operating procedures,
or to confirm that the routine monitoring programme (3.18) is suitable
3.20
triage monitoring programme
monitoring programme consist of frequent measurements performed in the nuclear medicine centres
that does not enable one to calculate a dose but to verify that a given threshold of potential intake (3.14)
is not surpassed
3.21
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected
abnormal events
3.22
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions, for example,
that significant intakes (3.14) have not occurred
3.23
individual monitoring
monitoring by means of equipment worn by individual workers, by measurement of the quantities
of radioactive materials in or on the bodies of individual workers, or by measurement of radioactive
material excreted by individual workers
3.24
workplace monitoring
monitoring using measurements made in the working environment
3.25
monitoring interval
period between two consecutive times of measurement
4 © ISO 2016 – All rights reserved

---------------------- Page: 12 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

3.26
quality assurance
planned and systematic actions necessary to provide adequate confidence that a process, measurement,
or service satisfy given requirements for quality such as those specified in a licence
3.27
quality control
part of quality assurance (3.26) intended to verify that systems and components correspond to
predetermined requirements
3.28
quality management
all activities of the overall management function that determine the quality policy, objectives, and
responsibilities and that implement them by means such as quality planning, quality control (3.27),
quality assurance (3.26), and quality improvement within the quality system
3.29
reference level
investigation level (3.30) or recording level (3.29)
3.30
recording level
level of dose, exposure, or intake (3.14) specified by the employer or the regulatory authority, at or
above which values of dose received by workers are to be entered in their individual records
3.31
investigation level
level of dose, exposure, or intake (3.14) at or above which investigation has to be made in order to reduce
the uncertainty associated with the dose assessment
3.32
retention function
function describing the fraction of an intake (3.14) present in the body or in a tissue, organ, or region of
the body after a given time has elapsed since the intake occurred
3.33
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.34
time of measurement
time at which the measurement begins
4 Symbols and abbreviated terms
A Value of the activity detection limit (in becquerel) for routine measurements
DL
AMAD Activity median aerodynamic diameter
3 -1
B Breathing rate of worker (m ·h )
-3
C Airborne concentration of radionuclide (Bq·m )
m
DL Detection limit
E(50) Committed effective dose accumulated for an integration period of 50 years following an unit intake (Sv)
e(50) Dose coefficient i.e. committed effective dose accumulated for an integration period of 50 years follow-
-1
ing a unit intake (Sv·Bq )
m(t) Predicted value of the measured quantity at time, t, for unit intake (excretion or retention function at
time t for unit intake)
I Intake (Bq)
IAEA International Atomic Energy Agency
© ISO 2016 – All rights reserved 5

---------------------- Page: 13 ----------------------
oSIST prEN ISO 16637:2019
ISO 16637:2016(E)

ICRP International Commission on Radiological Protection
ΔT Duration of the monitoring interval between two measurements in a routine monitoring programme
(in days)
T Time spent by the worker in the radioactive atmosphere (h)
work
5 Purpose and need for monitoring programmes in nuclear medical diagnosis
and therapy
5.1 General
The purpose of monitoring, in general, is to verify and document that the worker is protected adequately
against risks from radionuclide intakes and the protection complies with legal requirements. Therefore,
it forms part of the overall radiation protection programme, which should start with an assessment to
identify work situations in which there is a risk of radionuclide intake by workers, and to quantify the
annual likely intake of radioactive material and the resulting committed effective dose. Decisions about
the need for monitor
...