Iso Dis 16637 - 2013

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Title: Draft BS ISO 16637 Radiological protection - Monitoring and internal dosimetry for staff exposed to medical
radionuclides as unsealed sources
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DRAFT INTERNATIONAL STANDARD
ISO/DIS 16637
ISO/TC 85/SC 2 Secretariat: AFNOR

Voting begins on: Voting terminates on:
2014-01-15 2014-04-15
Radiological protection — Monitoring and internal

dosimetry for staff 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
ICS: 13.280
THIS DOCUMENT IS A DRAFT CIRCULATED

FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
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NATIONAL REGULATIONS.
ISO/DIS 16637:2013(E)
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2013
ISO/DIS 16637:2013(E)
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ii © ISO 2013 – All rights reserved

ISO/DIS 16637
Contents Page
Foreword ............................................................................................................................................................. v
Introduction ........................................................................................................................................................ vi
1 Scope ...................................................................................................................................................... 1
2 Normative references ............................................................................................................................ 2
3 Terms and definitions ........................................................................................................................... 2
4 Symbols and abbreviated terms .......................................................................................................... 6
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 ...................................................................................... 7
5.3 Monitoring programmes ....................................................................................................................... 9
5.3.1 General ................................................................................................................................................... 9
5.3.2 Confirmatory monitoring programmes ............................................................................................. 10
5.3.3 Triage monitoring programmes ......................................................................................................... 10
5.3.4 Routine monitoring programmes ...................................................................................................... 10
5.3.5 Special monitoring programmes ....................................................................................................... 10
5.3.6 Task-related monitoring programmes ............................................................................................... 10
6 General aspects ................................................................................................................................... 11
7 Reference levels .................................................................................................................................. 13
8 Routine Monitoring programmes ....................................................................................................... 14
8.1 General aspects ................................................................................................................................... 14
8.2 Individual monitoring .......................................................................................................................... 14
8.3 Methods and time intervals ................................................................................................................ 15
8.4 Derived recording level ....................................................................................................................... 16
9 Triage monitoring programmes ......................................................................................................... 16
10 Special Monitoring programmes ....................................................................................................... 17
10.1 General aspect ..................................................................................................................................... 17
10.2 Workplace monitoring ......................................................................................................................... 17
11 Confirmatory monitoring programmes ............................................................................................. 18
11.1 General aspect ..................................................................................................................................... 18
11.2 Workplace monitoring ......................................................................................................................... 18
12 Measurement techniques and performance criteria ........................................................................ 19
12.1 General ................................................................................................................................................. 19
12.2 In vitro ................................................................................................................................................... 19
12.3 In vivo ................................................................................................................................................... 20
12.4 Quality assurance and quality control for bioassay laboratories .................................................. 20
13 Procedure for the assessment of exposures ................................................................................... 21
13.1 Interpretation of workplace monitoring data for dose assessment ............................................... 21
13.2 Interpretation of individual monitoring data for dose assessment ................................................ 21
13.2.1 General ................................................................................................................................................. 21
13.2.2 Dose assessment based on routine monitoring .............................................................................. 21
13.2.3 Dose assessment based on special monitoring .............................................................................. 21
13.3 Software tools ...................................................................................................................................... 26
13.4 Uncertainties ........................................................................................................................................ 26
© ISO 2013 – All rights reserved iii

ISO/DIS 16637
13.5 Quality assurance of the assessment process ............................................................................... 27

14 Reporting and Documentation .......................................................................................................... 27
14.1 Reporting results for in vitro measurements ................................................................................... 27
14.2 Reporting results for in vivo measurements ................................................................................... 27
14.3 Documentation of the dose assessment .......................................................................................... 28
Annex A Example of dj estimation (informative) .......................................................................................... 29
Bibliography ..................................................................................................................................................... 30
iv © ISO 2013 – All rights reserved

ISO/DIS 16637
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
ISO 16637 was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
© ISO 2013 – All rights reserved v

ISO/DIS 16637
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 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, three ISO standards for the monitoring programmes (20553:2006), for the laboratory
requirements (28218:2010), and for the dose assessment (27048:2011) have been developed and can be
applied in a straightforward manner to many workplaces where internal contamination may occur. However,
their application for the staff involved in the diagnostic or therapeutic use of radionuclides in medicine requires
account to be taken of special aspects resulting from the short effective half-times of the nuclides in use and
from the distances between department of nuclear medicine and whole body and thyroid counting facilities or
laboratories undertaking spectrometry on urine samples. Consequently, guidance for the practical application
of the three standards cited above to the nuclear medicine staff was requested by a number of countries.
This International Standard offers guidance for the decision whether a monitoring is required for staff exposed
to medical radionuclides as unsealed sources and how it should be designed, for the dose assessment and
for the laboratories 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
exchanges of information between authorities, supervisory institutions and employers. The International
Standard is not a substitute for legal requirements.
vi © ISO 2013 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/DIS 16637
Radiological protection — Monitoring and internal dosimetry for

staff 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 exposure by the use of radionuclides as unsealed sources in
nuclear medicine departments and 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 standardised interpretation of
monitoring data.
This International Standard addresses the following items:
a) purposes of monitoring and of 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 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
 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;
© ISO 2013 – All rights reserved 1

ISO/DIS 16637
 detailed descriptions of measuring methods and techniques;
 dosimetry for litigation cases;
 modelling for the improvement of internal dosimetry;
 the potential influence of medical treatment of the internal contamination;
 the investigation of the causes or implications of an exposure;
 dosimetry for ingestion exposures.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
ISO 20553:2006, Radiation protection — Monitoring of workers occupationally exposed to a risk of internal
contamination with radioactive material
ISO 28218:2010, Radiation protection — Performance criteria for radiobioassay
ISO 27048:2011, Radiation protection — Dose assessment for the monitoring of workers for internal radiation
exposure
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
absorption characterised by its rate in the deposited material and which, depending on the material, is
denoted as being of type F, M or S
3.2
absorption type F
deposited materials that have high (fast) rates of absorption into body fluids from the respiratory tract
3.3
absorption type M
deposited materials that have intermediate (moderate) rates of absorption into body fluids from the respiratory
tract
3.4
absorption type S
deposited materials that have low (slow) rates of absorption into body fluids from the respiratory tract
3.5
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.
2 © ISO 2013 – All rights reserved

ISO/DIS 16637
3.6
activity median aerodynamic diameter
AMAD
value of aerodynamic diameter such that 50 % of the airborne activity 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.
3.7
contamination
activity 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
3.8
critical value
maximum value for the result of a single measurement in a monitoring programme where it is safe to assume
that the corresponding extrapolated annual dose does not exceed a predefined dose level
3.9
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
3.10
detection limit
smallest true value of the measurand which is detectable by the measuring method
3.11
annual dose
committed effective dose resulting from all intakes 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.
3.12
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue weighting
factors. In the context of this International Standard, the commitment period (integration time following the
intake) is taken to be 50 years
3.13
effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue weighting
factors
3.14
excretion function
fraction of an intake excreted per day after a given time has elapsed since the intake occurred
3.15
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
3.16
intake
activity of a radionuclide taken into the body in a given time period or as a result of a given event

ISO/DIS 16637
3.17
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, samples of other
materials such as blood and hair may be taken.
3.18
in vivo measurement
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.
3.19
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 (3.20), task-related monitoring programme (3.21), triage monitoring programme
(3.22), special monitoring programme (3.23), and confirmatory monitoring programme (3.24).
Note 2 to entry: This International Standard distinguishes two different types of monitoring, namely individual monitoring
(3.25) and workplace monitoring (3.26), which feature in each category.
3.20
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
3.21
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 is suitable
3.22
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 is not surpassed
3.23
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected abnormal
events
3.24
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions, for example that
significant intakes have not occurred
3.25
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

ISO/DIS 16637
3.26
workplace monitoring
monitoring using measurements made in the working environment
3.27
monitoring interval
period between two consecutive times of measurement
3.28
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
3.29
quality control
part of quality assurance intended to verify that systems and components correspond to predetermined
requirements
3.30
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, quality assurance
and quality improvement within the quality system
3.31
reference level
investigation level or recording level
3.32
recording level
level of dose, 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
3.33
investigation level
level of dose, exposure or intake at or above which investigation has to be made in order to reduce the
uncertainty associated with the dose assessment
3.34
retention function
function describing the fraction of an intake present in the body or in a tissue, organ or region of the body after
a given time has elapsed since the intake occurred
3.35
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.36
time of measurement
in vitro analysis time at which the biological sample (e.g. urine, faeces) was taken from the individual
concerned
3.37
time of measurement
in vivo analysis time at which the measurement begins

ISO/DIS 16637
4 Symbols and abbreviated terms

ADL Mathematical symbol for the detection limit, used in equations
Aj Cumulative activity of the radionuclide j present in the workplace over the course of a year (Bq)
AMAD Activity median aerodynamic diameter

3 -1
B Breathing rate of worker (m .h )
-3
Cm Airborne concentration of radionuclide (Bq.m )
dj Decision factor for radionuclide j (mSv)
D Decision factor for all radionuclides in the workplace (mSv)
DL Detection limit
DRL Derived recording level
E(50) Committed effective dose (Sv)

-1
e(50) Effective dose coefficient following a unit intake (Sv.Bq )
-1
ej(50) Effective dose coefficient following a unit intake for radionuclide j (Sv.Bq )
E(t) Value of the excretion function at time, t, (in days) after a unit intake
ffS Physical form safety factor based on the physical and chemical properties of the material being
handled
fhS Handling safety factor based on the experience of the operation being performed and the form of the
material
fpS Protection safety factor based on the use of permanent laboratory protective equipment
I Intake (Bq)
R(t) Value of the retention function at time, t, (in days) after a unit intake
T Time interval between two measurements in a routine monitoring programme (in days)
Twork Time spends by the worker in the radioactive atmosphere (h)
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 starts 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 monitoring and
the design of the monitoring programme should be made in the light of such a risk assessment.

ISO/DIS 16637
5.2 Assessment of the level of likely exposures
It is necessary to assess the likely magnitude of exposures without taking into account personal protective
measures. If available, this assessment can be done on the basis of results of earlier monitoring programmes
(individual or workplace monitoring) and/or on measurements perform at the workplace to characterize the
radiological conditions.
In nuclear medicine, workers can be contaminated by inhalation of volatile compounds (mainly radioiodine), or
aerosols. As a result, individual monitoring for internal contamination may be necessary for those workers who
[1]
regularly work with large activities of volatile radioactive materials .
In order to assess the level of likely exposures, quantification of airborne contamination should be performed
in departments where I-131 is used in large amount i.e. for therapy or where aerosols are used for pulmonary
inhalation examination.
To assess the risk of I-131 inhalation, aerosol sampling shall be performed in areas where there is a potential
for airborne radioactivity. These areas include:
 hot laboratory;
 radioiodine treatment rooms and adjacent areas;
 radioactive waste collection areas and waste water treatment plant.
For a specific radionuclide j, the likely committed effective dose due to airborne radioactivity for a worker can
be calculated by the following Equation:
I j  e j 50
E j 50  (1)
0,00
where
Ej(50) is the commited effective dose (mSv);
Ij is the intake (Bq) and;

-1
ej(50) is the dose coefficient (Sv Bq ) for inhalation of the radionuclide;
0,001 is a conversion factor from Sv to mSv.

[2] [3]
Values for e(50) shall be taken from ICRP 68 or from ICRP 53 and following addenda for
radiopharmaceuticals used as aerosols.
The likely intake can be calculated by the following Equation:
I  B  TWORK  Cm (2)
where
3 -1
B is the worker ventilation rate (1,2 m .h );
Twork is the time spent by the worker in the radioactive atmosphere (h) and;
-3
Cm is the airborne concentration of the radionuclide (Bq.m ).

ISO/DIS 16637
If no other reliable information is available or may be obtained from a limited monitoring on a sample of
worker, the likely annual dose can be estimated according to the criteria suggested by IAEA Safety Guide RS-
[4]
G-1.2 in order to determine whether an internal monitoring program is needed for nuclear medicine
[5][6][7]
workers .
This criterion is based on the estimation of a “decision factor”, dj, corresponding to the order of magnitude of
the annual dose likely to be received by a worker, defined for a specific radionuclide j and a specific practice
as:
Aj  e j 50  f fS  f hS  f pS
dj  (3)
0,001
where
dj is the decision factor (mSv);
Aj is the cumulative activity (Bq) of the radionuclide j present in the workplace over the course of
the year;
ej(50) is the dose coefficient (Sv/Bq) for inhalation of radionuclide j, with the AMAD normally taken to
be 5 m for worker as considered by ICRP 78. This default parameter may not fit the actual
particle size distribution present at the workplace. If there is documented evidence of smaller
aerosol dimensions (by example data issued from air monitoring), another value of AMAD can
be considered;
ffS is the physical form safety factor based on the physical and chemical properties of the material
being handled;
fhS is the handling safety factor based on the experience of the operation being performed and the
form of the material and;
fpS is the protection safety factor based on the use of permanent laboratory protective equipment
(e.g. glove box, fume hood);
0,001 is a conversion factor from Sv to mSv.
Values for e(50) shall be taken from ICRP 68 or from ICRP 53 and following addenda for
radiopharmaceuticals used as aerosols.
In the majority of cases, ffS should be 0,01, therefore the above equation may be simplified to:
d j  10 Aj  e j 50  f hS  f pS (4)
IAEA Safety Guide RS-G-1.2 presents suggested values of fhS and fpS in Tables 1 and 2 respectively.

ISO/DIS 16637
Table 1 — Handling safety factors
Process Handling safety factors

Storage (stock solution) 0,01
Very simple wet operations 0,1
Normal chemical operations 1
Complex wet operations with risk of spills 10
Simple dry operations 10
Handling of volatile compounds 100
Dry and dusty operations 100
Table 2 — Protection safety factors
Protection measure Protection safety factor fps

Open bench operations 1
Fume hood 0,1
Glove box 0,01
The IAEA methodology may be excessively restrictive when applied to nuclear medicine practices. Therefore,
[8]
additional correction factors may be taken into account if they are approved by the national regulatory
authority including.
 individual workload;
 fraction of handled activity by each worker;
 fraction of the handled activity that could be incorporated by the worker through aerolization or
volatization.
An example of dj estimation including these three additional correction factors is provided in Annex A.
The decision factor D (mSv) for all radionuclides in the workplace is the sum of all radionuclide specific
decision factors:
D dj (5)
j
If D is 1 mSv or more, individual monitoring should be performed, and if D is less than 1 mSv, individual
monitoring may not be necessary.
When more than one radionuclide is present in the workplace, all radionuclides for which dj  1 shall be
monitored.
5.3 Monitoring programmes
5.3.1 General
Individual monitoring gives information needed to assess the exposure of a single worker by measuring
individual body activities, excretion rates or activity inhaled (using personal air samplers).
Workplace monitoring, either by air monitoring or by measurements of the surface contamination, helps to
assess the internal exposure of workers through inhalation and provide information on the risk of
contamination for setting up individual monitoring programmes for workers.

ISO/DIS 16637
Factors determining the need for a monitoring programme are:
 the magnitude of likely exposures;
 the need to recognise incorporation events;
 the need to assess the effectiveness of protective equipment (RPE).
A monitoring programme for internal contamination is required if the worker is occupationally exposed and the
assessed dose contribution from intakes of radionuclides is likely to be significant. The recommended level of
the likely annual committed effective dose to initiate monitoring is 1 mSv.
5.3.2 Confirmatory monitoring programmes
Confirmatory monitoring, which consists of workplace and/or individual monitoring performed at regular
intervals (by example every month for workplace measurements or every six months for individual
measurements) should be required to check the assumptions about exposure conditions underlying the
procedures selected, e.g. the effectiveness of protection measures. Recorded data should be periodically
review as they can demonstrate the need for triage, routine or task related monitoring. The time of
implementation should be during the process identified as the highest risk of internal exposure.
5.3.3 Triage monitoring programmes
Triage monitoring programmes rely on frequent individual screening measurements performed at the
workplace to the whole staff at risk to detect whether potential intake has occurred. If the screening threshold
is exceeded, in vivo or in vitro radiobioassays are performed in order to confirm internal contamination and to
quantify the incorporated activity for dose assessment.
5.3.4 Routine monitoring programmes
Routine monitoring programmes are performed to quantify exposures where there is the possibility either of
undetected accidental intakes or of chronic intakes. The basis for routine monitoring programmes is the
assumption that working conditions, and thus risks of intake, remain reasonably constant. The design of such
a programme of regular measurements strongly depends on the level of the annual dose the quantification of
which is ensured. This level should be well below legally relevant limits; its definition should take into account
uncertainties, for example in activity measurement and dose assessment. If this level is too high, intakes
representing considerable fractions of dose limits could be overlooked, whilst a low value can cause the
expenditure of unnecessary efforts at low exposures.
5.3.5 Special monitoring programmes
Special monitoring programmes are performed to quantify significant exposures following actual or suspected
abnormal events (by example the spill of a radiopharmeutical solution) or in case of a positive screening
during triage monitoring. Therefore, in comparison to routine monitoring programmes, the time of intake is
usually much better known and additional information can be available, which helps to reduce the uncertainty
of assessment. The purposes of dose assessment in such cases include assisting in decisions about
countermeasures (e.g. decorporation therapy), compliance with legal regulations and aiding decisions for the
improvement of conditions at the workplace. In most cases, special monitoring programmes are performed
individually. In cases where there is reason to suspect that exposure limits could be exceeded, it can be
appropriate to extend the measurements in order to derive individual retention and excretion functions and
biokinetic model parameters
5.3.6 Task-related monitoring programmes
Task-related monitoring programmes apply to a specific operation. The purpose and the dose criteria for
carrying out task-related monitoring programmes are identical to those for routine monitoring programmes.

ISO/DIS 16637
In nuclear medicine, task-related monitoring programmes are required in the case of a new diagnostic or
therapeutic protocol and operations of limited duration to provide data for dose assessment and for the
radiation protection optimisation process. The general requirements set out in 8.1 for routine monitoring
programmes shall be applied to task-related monitoring programmes.
When the operation is planned, an appropriate monitoring programme shall be devised. This is also necessary
after major modifications have been applied to the installations or operating procedures.
This task-related workplace monitoring (measurement of airborne activity, surface wipe tests, etc.)
complements individual monitoring, since it provides useful indicators for predicting doses and for establishing
protective measures for the operation. However, individual monitoring gives more reliable dose estimates.
In contrast to routine monitoring programmes, more information can be available about the circumstances of
an intake event, especially relating to the time between measurement and the intake.
The objectives of a task-related monitoring programme and the way it is organized, including the basis for
interpreting the results, shall be documented according to Clause 13.
A detailed flowchart is proposed as Figure 1 to contribute with the implementation of monitoring programmes.
Figure 1 — Flowchart for the implementation of monitoring programmes
6 General aspects
Most of the radionuclides used in nuclear medicine have short half-lives (Table 3). For diagnostic use, the
emitted energy shall be deposited in the camera crystal, with minimal absorption by the tissue. On the

ISO/DIS 16637
contrary, for therapeutic use, the energy shall be deposited in the tissue. Therefore,  emitting radionuclides
are used for imaging while  and  emitters are used for therapeutic purposes.

ISO/DIS 16637
Table 3 — Most commonly used radionuclides in nuclear medicine

*
Radionuclides Half-life Main emissions
 
i
C-11 20,39 m
 
i
O-15 122,24 s
e-, 
i
F-18 109,77 m
Ga-67 3,2612 d e-, X
 ,
I
Ga-68 67,71 m
Sr-89 50,53 d 
Y-90 64,10 h -
Tc-99m 6,015 h e-, X
In-111 2,8047 d e-, X
I-123 13,27 h e-, X
I-131 8,02070 d e-, X
Sm-153 46,50 h e-, X
Er-169 9,40 d 
Lu-177 6,647 d 
Re-186 3,7183 d e-, X
Re-188 17,0040 h e-, X
Tl-201 72,912 h e-, X
Ra-223 11,43 d  X
 [8]
according to ICRP 107
i Annihilation photons.
7 Reference levels
Reference levels are the values of quantities above which a particular action or decision shall be taken. The
purpose of setting these levels is so that unnecessary, non-productive work can be avoided and resources
can be used where they are most needed. Reference levels include the recording level, above which a dose
assessment has to be recorded, lower values being ignored; and the investigation level, above which the
exposure estimates have to be confirmed by additional investigations (see Table 4).
NOTE The scope of this International Standard does not include the investigation of the causes or implications of an
exposure or intake.
The recording level shall be set at a value corresponding (having regard to the length of the monitoring
interval) to an annual dose no higher than 5 % of the annual dose limit. The investigation level shall be set at a
value corresponding to an annual dose no higher than 30 % of the annual dose limit.
Table 4 — Reference levels for monitoring internal exposures (ISO 20553)
Level Meaning
Recording level The recording level is the level of dose, exposure or intake at or
above which dose assessments have to be recorded in the individual
exposure records. It shall be set at a value corresponding to an

ISO/DIS 16637
annual dose no higher than 5 % of the annual dose limit. Results

falling below this level may be shown as “below recording level”.
Investigation level The investigation level is a level of dose, exposure or intake at or
above which investigation has to be made in order to reduce the
uncertainty associated with the dose assessment. The level shall be
set at a value corresponding to an annual dose no higher than 30 %
of the annual dose limit.
8 Routine Monitoring programmes
8.1 General aspects
Measurements in a routine monitoring programme are made at pre-determined times and are not related to
any known intake events. Decisions therefore have to be made in advance concerning methods, frequencies,
and the underlying biokinetic models. For the evaluation of measured values in terms of intakes it also is
necessary to make assumptions concerning the time interval between intake and measurement.
The following general requirements shall be observed when specifying a routine monitoring programme:
 the consequences resulting from an unknown time interval between intake and measurement shall be
limited so that:
 on average over many monitoring intervals, doses are not underestimated, and
 the maximum underestimate of the dose resulting from a single intake does not exceed a factor of
three, and
 the detection of all annual exposures that can exceed 1 mSv shall be ensured;
 at least two measurements shall be performed annually.
The maximum overestimation is in nearly all cases greater than the maximum underestimation. The constraint
on the maximum underestimation of a single intake does not exclude a considerable overestimation.
These requirements together with the assumptions about the pattern of intake and the sensitivity of the
selected methods of measurement determine the frequency of the routine measurements.
In nuclear medicine, routine monitoring based on individual measurements can be performed to monitor the
risk of iodine 131 inhalation when significant activities in volatile forms are manipulated.
In vivo thyroid measurements can be performed in a radiobioassay laboratory or in the nuclear medicine
department using gamma camera[9] or thyroid probe[10][11].
The objectives of a monitoring programme and the way it is to be organized shall be documented according to
Clause 11 including the basis for interpreting the results. The monitoring programme shall be reviewed by
means of a confirmatory monitoring programme after any major modifications have been made to the
installation, to operations, or to the regulatory requirements.
8.2 Individual monitoring
Individual monitoring of radionuclides can be made by in vivo measurements or in vitro analyses, by taking
continuous air samples using individual air-sampling devices or by a combination of all these methods. The
selection depends on a number of factors, such as the following:
 radiation emitted by the radionuclide and its progeny;

ISO/DIS 16637
 decay rate of the radionuclide;
 retention in the body or the excretion rate from the body of the radionuclide as a function of the time
between intake and measurement;
 biokinetics, organ deposition and excretion pathway of the radionuclide;
 technical feasibility of measurement.
The measurement frequency required for a routine monitoring programme depends on the retention and
excretion of the radionuclide, the sensitivity of the available measurement techniques and the uncertainty that
is acceptable when estimating annual intake and committed effective dose, as given in Equations 6 and 7:
For in vivo measurements:
e50 
ADL 365
  1 mSv (6)
RT  T
For in vitro analyses:
e50 
ADL 365
  1 mSv (7)
E T  T
The maximum potential underestimation shall not exceed a factor of three; assuming that a single intake
occurred in the middle of the monitoring interval this requirement means, as given in Equations 8 and 9:
For in vivo measurements:
 T 
R 
 2  3 (8)
RT 
For in vitro analyses:
 T 
E 
 2 
3 (9)
E T 
8.3 Methods and time intervals
The methods and time intervals summarized in this subclause were derived from the principles laid down
above and the following assumptions:
 ICRP 66 [12] models for inhalation (default values for workers: AMAD = 5 μm);
 element-specific retention and excretion functions defined by ICRP 78 [13]

;
 acute intake by inhalation at the mid-point of the monitoring interval. This is a reasonable assumption for
chronic intakes and, on average, it prevents the underestimation of intakes;
 with DL values of routine measurements as from ICRP 78.
For the routine monitoring of I-131, the maximum time interval between the thyroid measurements is 15 days.
When thyroid measurements cannot be performed, an alternative is to proceed urine in vitro analyses with the

ISO/DIS 16637
same maximum time interval i.e.15 days knowing that for urine monitoring, the 1 mSv detection level may not
be achieved. Tolerance on the time interval should not exceed 2 days.
8.4 Derived recording level
The derived recording level (DRL) is the activity measured that, if it is detected in each monitoring interval,
corresponds to an annual committed effective dose at the recording level as stated in clause 7. It depends
upon the time interval. If the recording level of dose is set to a value of 1 mSv, the DRL can be calculated
using Equation 10 after in vivo measurements or Equation 11 after in vitro measurements.
 T 
R 
3  2  T
DRL  10   (10)
e50 365
 T 
E 
2  T
DRL  10 3    (11)
e50 365
For the monitoring of I-131 intake with a time interval of 15 days, the derived recording level for thyroid
measurement is 300 Bq. and for urine measurements, the DRL is 0,4 Bq/day (considering a recording level of
dose set to a value of 1 mSv).
9 Triage monitoring programmes

For most radionuclides with shorter half-life, individual routine monitoring as defined above is not possible or
inadequate. In this case, a possibility is to implement triage monitoring in the nuclear medicine department
and in case of positive result, to initiate in vivo counting or in vitro urinalysis in a radiobioassay service
[14]
laboratory in order to evaluate the committed effective dose, E(50) .
Triage monitoring is based on frequent screening measurements performed at the workplace by local staff
using standard laboratory instrumentation. Screening procedures can be set for most radionuclides used in
nuclear medicine.
[15]
The procedure can consist in :
 measurements by a calibrated surface contamination monitor placed in front of the thyroid every day for I-
123 or every week for I-131;
 daily measurements with a calibrated dose rate monitor placed in front of the abdomen for radionuclides
with very short physical half-lives (≤ 6 h), such as Tc-99m and those used in positron emission
tomography imaging, i.e. C-11, O-15, F-18 and Ga-67;
 measurements with a lung monitor or a calibrated dose rate monitor located in front of the thorax for other
gamma emitters used for imaging, i.e. Ga-67, In-111 and Tl-201;
 measurements with a hand contamination monitor immediately after use for pure beta emitters, i.e. Y-90
and Er-169, as well as beta emitters with low-intensity gamma rays, i.e. Sm-153, Lu-177, Re-186 and
Re-188.
Workplace monitoring including measurements of surface contamination can also be performed as part of a
triage monitoring programme.

ISO/DIS 16637
10 Special Monitoring programmes
10.1 General aspect
Special monitoring programmes refer to measurements made when intake is suspected following an event
and shall be conducted to provide data for:
 dose assessment required for estimating risk and determining the need for any treatment;
 radiological protection optimization process.
In contrast to routine monitoring programmes, special monitoring programmes can reveal more information
about the circumstances of an intake event, especially relating to the time between the measurement and the
intake.
The objectives of a special monitoring programme and the way it is organized, including the basis for
interpreting the results, shall be documented in accordance with Clause 13.
10.2 Workplace monitoring
Special workplace monitoring is based on the same principles as for routine workplace monitoring and the
same requirements shall be fulfilled (see 8.1).
The circumstances of each event are particular, for example, in the level of activity and duration of exposure,
so it is difficult to standardize special workplace monitoring. The distribution of radioactive contamination
should be assessed using air monitoring and surface contamination monitoring. Devices fitted with alarms and
which operate continuously should be used whenever operations or malfunctioning is likely to produce
significant releases of radioactive material in the workplace. The location of these devices should be chosen
so that they can reliably detect the release of radioactive material; this is not necessarily at points that are
representative of the workers’ breathing area.
The goal of special individual monitoring is to ensure that any intake is detected at an early stage and that the
associated committed doses are evaluated. Special monitoring programmes are investigative; they are usually
based on a suitable combination of in vivo measurements and in vitro analyses in association with the
appropriate biokinetic model.
 In vivo measurement: The radionuclide content of the body is quickly available and gives an indication
whether a significant intake has occurred.
 In vitro analysis: Usually, a reliable dose assessment on the basis of urinary analysis requires a 24 h
sample; but in the case of special monitoring programmes, it can be helpful to collect “spot samples”.
Table 5 summarizes recommended methods for individual monitoring; it does not take into account the effects
of treatment that can be undertaken to reduce the committed effective dose.
Table 5 — Recommended methods for special monitoring programmes after inhalation
In vitro analyses In vivo measurements

Radionuclide/material Urine Organ
Spot sample 24 h WB Thyroid
F-18 + ++
Ga-67 + ++

ISO/DIS 16637
Sr-89 ++
Y-90 ++
Tc-99m + ++
In-111 ++
I-123 + ++
I-131 + ++
Sm-153 + ++
Er-169 ++ +
Lu-177 + ++
Re-186 + ++
Re-188 + ++
Tl-201 + ++
Ra-223 ++
++ = Recommended, += Supplementary (helpful but not mandatory) WB =Whole Body
18
In case of suspected incorporation of FDG, in vivo brain monitoring of F-18 is effective to detect levels below
[16]
the 1 mSv .
C-11 and O-15 are not listed due to their very short half-life (see Table 3), however contamination by C-11 can
be detected by in vivo measurements performed very rapidly after the intake event.
11 Confirmatory monitoring programmes
11.1 General aspect
Confirmatory monitoring programmes are required to check the assumptions about exposure conditions
underlying the procedures selected, e.g. the effectiveness of protection measures. It may consist of workplace
or individual monitoring. Periodic measurements can be made to ensure that working conditions are
satisfactory. In association with the Radiation Protection Officer, the results of workplace monitoring (wipe
tests and air sample measurements) and contamination measurements made on individuals can be compared
and the radiation protection system modified if necessary.
11.2 Workplace monitoring
Area monitoring is related to the nature of the radionuclides and the type of work undertaken. In the presence
of a relatively high radiation background, the direct detection of significant levels of surface contamination may
not be possible, and wipe tests to assess the degree of loose contamination may be necessary. In areas
where surface contamination may arise or its presence is suspected, the entire area and contents should be
regarded as being contaminated until monitoring indicates otherwise. (ICRP 57)
Workplace monitoring includes measurements of airborne activity when extensive use is made of volatile
materials or radioactive gases (by example large amount of I-131 in liquid form or Tc 99m-labelled aerosols)
and surface contamination in the workplace.
Surface monitoring is related to the nature of the radionuclides and the type of work undertaken. In the
presence of a relatively high radiation background, the direct detection of significant levels of surface
contamination may not be possible, and wipe tests to assess the degree of loose contamination may be
necessary. In areas where surface contamination may arise or its presence is suspected, the entire area and
contents should be regarded as being contaminated until monitoring indicates otherwise (ICRP 57).

ISO/DIS 16637
The main objectives of monitoring airborne activity are
 to help to assess the likely internal exposure of workers through inhalation;
 to provide information for setting up individual monitoring programmes for workers.
I-131 airborne activity can be measured in the hot laboratory, radioiodine treatment rooms, radioactive waste
collection areas and the waste water treatment plant.
The assessment of effective dose based on air monitoring data can be performed as stated in subclause 5.2.
Individual monitoring as part of confirmatory monitoring serves to confirm the adequacy of protective
measures and of assumptions made regarding the level of exposures. Individual monitoring can be performed
via periodic in vivo measurements or urine analysis. However; due to the short half-lives of radionuclides in
use for diagnostic or therapeutic administration in nuclear medicine, in vivo measurements are more adequate
to detect contamination particularly by common radionuclides such as Tc-99m or F-18.
The in vivo measurements can be performed in whole body counting facilities located near the nuclear
medicine department. For departments located far from such facilities, mobile laboratories can be developed
in order to perform on-site measurements [17][18][19].
12 Measurement techniques and performance criteria
12.1 General
For routine monitoring, special monitoring, or confirmatory monitoring, in vitro and/or in vivo measurement
techniques, workplace monitoring techniques, or a combination of these techniques, may be used, depending
on factors such as the chemical composition of contaminant involved, the likely level of contamination, and the
availability of these measurement techniques.
As stated above, I-131 presents a high risk of intake and is the largest cause of internal dose to nuclear
medicine workers. Due to the cost associated with transporting workers or bioassay samples to laboratory,
nuclear medicine centres may use their own devices to perform the monitoring of the workers involved in a
radioiodine handling procedure. Measurements can be performed using gamma camera [5] or thyroid probe [9][8].
As detailed description of the measurement methods and techniques is beyond the scope of this standard, the
following subclauses give a brief introduction to the measurement techniques available for in vitro and in vivo
measurement.
Radiobioassay services laboratories which perform in vivo or in vitro measurements for nuclear medicine staff
should apply criteria developed in ISO 28218:2010. These criteria should be applied by stationary as well as
by mobile laboratories.
For thyroid measurements performed in the nuclear medicine services, the present International Standard
specifies the requirements to apply (see subclause 12.3).
12.2 In vitro
In vitro measurement is applicable for the monitoring of the internal contamination by radionuclides used in the
nuclear medicine department. Urine analysis is the only bioassay method usually employed. Collection of a
24-h urine sample from the affected individual is recommended.
The usual method, for the quantification of  emitting radionuclides, is the direct measurement of the 
radiations by  spectrometry of a test specimen. The detection limit at the date of measurement is
approximately 1 Bq/l, for a test specimen of 500 ml and a counting time of 60 min.

ISO/DIS 16637
The quantification of β emitter radionuclides is also a direct method, by liquid scintillation making it possible to
reach a limit of detection of approximately 50 Bq/l, for a test specimen of 2 ml and a counting time of
60 minutes.
These measurements cannot be performed in the nuclear medicine department, but in a radiobioassay
laboratory as they require important technical equipment.
12.3 In vivo
For thyroid measurements of I-131 performed in the nuclear medicine departments as part of a routine
monitoring program, the methodology of measurements shall be written, including:
 description of equipment (detector, analyzer, software) used to analyse the spectra;
 description of the phantom used for calibration;
 counting configuration.
The measurements should be performed in a location with as low a background count rate as possible. The
DL (detection limit) of the unit shall be determined. For routine monitoring, it shall be lower than the derived
recorded level as defined in 8.4.
12.4 Quality assurance and quality control for bioassay laboratories
Performance checks shall be conducted to ensure the conformance of analytical processes, measurement
equipment and the facilities to predetermine operational requirements. The laboratory shall have written
quality control procedures to verify that the quality of measurements or radioactivity determinations complies
with the accuracy requirements as developed in ISO 28218:2010. The quality control procedures shall include
the following:
a) use of traceable radionuclide reference standards;
b) performance checks of measurement systems;
c) instrument calibration;
d) intra-laboratory analyses (e.g. known quantities, replicates and blanks);
e) participation in available inter-laboratory inter-comparison programmes;
f) computational checks;
g) review of procedures, specifications and operating logs;
h) observation of operations and evaluation of quality control data;
i) evaluating conformance to the performance criteria of this International Standard; and
j) evaluating quality control data to ensure the long-term consistency of analytical results.
In addition, laboratories performing in vivo or in vitro analyses and/or assessments for internal dosimetry
should participate in national or international intercomparison exercises.

ISO/DIS 16637
13 Procedure for the assessment of exposures
13.1 Interpretation of workplace monitoring data for dose assessment
Dose assessment can be performed using airborne contamination measurements as described in

subclause 5.2.
13.2 Interpretation of individual monitoring data for dose assessment
13.2.1 General
The general procedure for the assessment of exposures is described in the standard ISO 27048:2011.
Internal dose assessment can be performed based on individual monitoring data after routine or special
monitoring. Dose assessment is performed using the results of in vivo measurement or urine analysis. When
possible, the biokinetic model corresponding to the physico-chemical form of the contaminant shall be used.
In case of special monitoring, time of intake is usually known. In routine monitoring, the time of any acute
intake is generally unknown. Typically, it is assumed that the intakes take place at the midpoint of the interval.
In this case, a uniform chronic intake can also be considered.
13.2.2 Dose assessment based on routine monitoring
For I-131, the activity measured in the thyroid corresponding to a committed effective dose of 1 mSv (for an
unique intake at one monitoring interval) is 6700 Bq The activity measured in urine corresponding to the same
-1
dose is 9,1 Bq.d . These values are given for a time interval of 15 days as specified in subclause 8.3 and for
I-131 with pulmonary absorption parameter type F and 5 m AMAD.
13.2.3 Dose assessment based on special monitoring
In the case of iodine contamination, dose assessment can be performed using thyroid measurements and/or
urine analysis. Tables 6 to 8 give the activities of I-131 measured in the thyroid and the daily urine excretion
-1
(Bq.d ) that correspond to a committed effective dose of 1 mSv from inhalation of I-131 as elemental vapour
(Table 6) or as aerosol (pulmonary absorption type F and AMAD 5 m, Table 7) or from injection of I-131
(Table 8). Tables 9 to 11 give the activities of I-123 measured in the thyroid and the daily urine excretion
-1
(Bq.d ) that correspond to a committed effective dose of 1 mSv from inhalation of I-123 as elemental vapour
(Table 9) or as aerosol (pulmonary absorption type F and AMAD 5 m, Table 10) or from injection of I-123
(Table 11).
Table 6 — Activity in the thyroid and daily urinary excretion after inhalation of I-131 as elemental
vapour corresponding to a committed effective dose of 1 mSv
-1
Time after intake in days Thyroid activity (Bq) Daily urinary excretion (Bq.d )
1 1,14E+04 2,62E+04
2 1,12E+04 2,31E+03
3 1,02E+04 1,38E+02
4 9,27E+03 1,42E+01
5 8,44E+03 8,40E+00
6 7,68E+03 9,04E+00
7 6,99E+03 9,73E+00
8 6,36E+03 1,02E+01
9 5,79E+03 1,04E+01
10 5,27E+03 1,05E+01

ISO/DIS 16637
Table 7 — Activity in the thyroid and daily urinary excretion after inhalation of I-131 as an aerosol
(absorption type F, AMAD 5 µm) corresponding to a committed effective dose of 1 mSv
-1
1 1,09E+04 2,48E+04
2 1,08E+04 2,85E+03
3 9,91E+03 1,71E+02
4 9,02E+03 1,58E+01
5 8,20E+03 8,17E+00
6 7,47E+03 8,69E+00
7 6,79E+03 9,37E+00
8 6,18E+03 9,82E+00
9 5,63E+03 1,01E+01
10 5,12E+03 1,01E+01
Table 8 — Activity in the thyroid and daily urinary excretion after injection of I-131 corresponding to a
committed effective dose of 1 mSv
-1
1 1,16E+04 2,68E+04
2 1,13E+04 2,04E+03
3 1,03E+04 1,22E+02
4 9,35E+03 1,33E+01
5 8,51E+03 8,48E+00
6 7,74E+03 9,17E+00
7 7,05E+03 9,86E+00
8 6,41E+03 1,03E+01
9 5,84E+03 1,05E+01
10 5,31E+03 1,06E+01
Table 9 — Activity in the thyroid and daily urinary excretion after inhalation of I-123 as elemental
vapour corresponding to a committed effective dose of 1 mSv
-1
1 3,59E+05 8,23E+05
2 1,08E+05 2,24E+04
3 3,06E+04 4,14E+02
4 8,60E+03 1,31E+01
5 2,42E+03 2,41E+00
6 6,81E+02 8,01E-01
7 1,91E+02 2,67E-01
8 5,39E+01 8,62E-02

ISO/DIS 16637
9 1,52E+01 2,72E-02
10 4,26E+00 8,46E-03
Table 10 — Activity in the thyroid and daily urinary excretion after inhalation of I-123 as an aerosol
(absorption type F, AMAD 5 µm) corresponding to a committed effective dose of 1 mSv
-1
1 3,70E+05 8,42E+05
2 1,14E+05 2,99E+04
3 3,22E+04 5,55E+02
4 9,06E+03 1,58E+01
5 2,55E+03 2,54E+00
6 7,16E+02 8,34E-01
7 2,02E+02 2,78E-01
8 5,67E+01 9,00E-02
9 1,60E+01 2,85E-02
10 4,49E+00 8,86E-03
Table 11 — Activity in the thyroid and daily urinary excretion after injection of I-123 corresponding to a
-1
1 3,60E+05 8,28E+05
2 1,08E+05 1,95E+04
3 3,04E+04 3,59E+02
4 8,54E+03 1,22E+01
5 2,40E+03 2,39E+00
6 6,76E+02 8,00E-01
7 1,90E+02 2,66E-01
8 5,35E+01 8,59E-02
9 1,50E+01 2,71E-02
10 4,23E+00 8,43E-03
In the case of Tc-99m contamination in the form of pertechnetate, dose assessment can be performed using
whole body measurements and/or urine analysis. Table 12 gives the activities of Tc-99m measured in the
-1
whole body and the daily urine excretion (Bq.d ) that correspond to a committed effective dose of 1 mSv from
inhalation of Tc-99m as pertechnetate aerosol (pulmonary absorption type F and AMAD 5 m).
Table 12 — Activity in the whole body and daily urinary excretion after inhalation of Tc-99m as
pertechnetate corresponding to a committed effective dose of 1 mSv
-1
Time after intake in days Whole body activity (Bq) Daily urinary excretion (Bq.d )
1 1,62E+06 1,92E+05
2 6,73E+04 9,24E+03

ISO/DIS 16637
3 2,92E+03 3,83E+02
4 1,31E+02 1,63E+01
5 6,04E+00 7,06E-01
In the case of Ga-67 contamination in the form of citrate, dose assessment can be performed using whole
body measurements and/or urine analysis. Table 13 gives the activities of Ga-67 measured in the whole body
-1
and the daily urine excretion (Bq.d ) that correspond to a committed effective dose of 1 mSv from inhalation
of Ga-67 as aerosol (pulmonary absorption type F and AMAD 5 m).
Table 13 — Activity in the whole body and daily urinary excretion after inhalation of Ga-67 as
-1
1 3,89E+06 1,03E+05
2 2,08E+06 8,96E+04
3 1,26E+06 4,17E+04
4 8,54E+05 1,95E+04
5 6,28E+05 9,85E+03
6 4,81E+05 5,56E+03
7 3,76E+05 3,51E+03
8 2,97E+05 2,42E+03
9 2,36E+05 1,78E+03
10 1,88E+05 1,36E+03
In the case of Sr-89 contamination in the form of chloride, dose assessment can be performed using urine
-1
analysis. Table 14 gives the daily urine excretion of Sr-89 (Bq.d ) that correspond to a committed effective
dose of 1 mSv from inhalation of Sr-89 as aerosol (pulmonary absorption type F and AMAD 5 m).
Table 14 — Daily urinary excretion after inhalation of Sr-89 as pertechnetate corresponding to a

-1
Time after intake in days Daily urinary excretion (Bq.d )
1 4,81E+04
2 1,63E+04
3 1,07E+04
4 7,89E+03
5 6,15E+03
6 4,95E+03
7 4,09E+03
8 3,45E+03
9 2,96E+03
10 2,58E+03

ISO/DIS 16637
In the case of In-111 contamination in the form of chloride, dose assessment can be performed using whole
body measurements. Table 15 gives the activities of In-111 measured in the whole body that correspond to a
committed effective dose of 1 mSv from inhalation of In-111 as aerosol (pulmonary absorption type F and
AMAD 5 m).
Table 15 — Activity in the whole body after inhalation of In-111 as pertechnetate corresponding to a
Time after intake in days Whole body activity (Bq)

1 1,98E+06
2 1,11E+06
3 7,22E+05
4 5,19E+05
5 3,93E+05
6 3,03E+05
7 2,36E+05
8 1,85E+05
9 1,44E+05
10 1,13E+05
In the case of Tl-201 contamination in the form of citrate, dose assessment can be performed using whole
body measurements and/or urine analysis. Tables 16 gives the activities of Tl-201 measured in the whole
-1
body and the daily urine excretion (Bq.d ) that correspond to a committed effective dose of 1 mSv from
inhalation of Tl-201 as aerosol (pulmonary absorption type F and AMAD 5 m).
Table 16 — Activity in the whole body and daily urinary excretion after inhalation of Tl-201 as
-1
1 6,16E+06 1,39E+05
2 4,05E+06 1,6E+05
3 2,86E+06 9,39E+04
4 2,08E+06 6,98E+04
5 1,53E+06 5,19E+04
6 1,14E+06 3,85E+04
7 8,43E+05 2,86E+04
8 6,26E+05 2,13E+04
9 4,65E+05 1,58E+04
10 3,45E+05 1,17E+04

ISO/DIS 16637
In the case of Ra-223 contamination in the form of chloride, dose assessment can be performed using urine
-1
analysis. Table 17 gives the daily urine excretion of Ra-223 (Bq.d ) that correspond to a committed effective
dose of 1 mSv from inhalation of Ra-223 as aerosol (pulmonary absorption type M and AMAD 5 m).
Table 17 — Daily urinary excretion after inhalation of Ra-223 as pertechnetate corresponding to a

-1
Time after intake in days Daily urinary excretion (Bq.d )
1 2,62E-01
2 4,85E-02
3 3,03E-02
4 2,02E-02
5 1,36E-02
6 9,37E-03
7 6,55E-03
8 4,68E-03
9 3,44E-03
10 2,60E-03
Alternatively, smaller values in activity median aerodynamic diameter of aerosols or other pulmonary
absorption types may be used provided they are documented, validated and appropriate for the process in
which the individual was engaged.
13.3 Software tools
The criteria for selecting one software or computer code for bioassay data interpretation are based in the
requirement of the following capabilities of the software:
a) type of intake (inhalation, ingestion, injection), pattern of intake (acute, chronic or mixed) and date of
intake;
b) type of information on the element or compound, such as number of radionuclides available,

physicochemical characteristics of the compound (AMAD or absorption parameters) and choice between
default and/or specific values;
c) type of measurement (urine, whole body, thyroid), the possibility of simultaneously treating several data,
the flexibility of entering, handling and treating data (type of uncertainties, implemented algorithms for
automatic and/or interactive data processing, problems of values in the range of limit of detection);
d) models available for calculation: biokinetic models of ICRP 78 or other models;
e) methods of data fitting and interpretation and the possibility of trading several data values and data from
more than one monitoring methods.
13.4 Uncertainties
The distributions of a measured bioassay quantity arising from the various components of uncertainty can be
described using lognormal distributions, with the uncertainty quantified using the geometric standard
deviation. The geometric standard deviation is often known as the scattering factor (KSF) and values are
provided in ISO 27048 standard Annex B.

ISO/DIS 16637
The general procedure for the assessment of uncertainties is described in the standard ISO 27048:2011
13.5 Quality assurance of the assessment process
The continued effectiveness of any radiation programme relies on those in charge implementing its various
components, including the adoption of an effective quality assurance (QA) programme based on ISO 28218,
ISO 20553 and ISO 27048. Quality assurance includes quality control, which involves all those actions by
which the adequacy of tools and procedures is assessed against established requirements. QA requirements
may be determined by national regulations.
14 Reporting and Documentation
14.1 Reporting results for in vitro measurements
The results obtained by the service laboratory shall be reported to the customer and shall include the following
items as a minimum:
a) sample identification:
1) assigned number;
2) total volume or mass of sample submitted;
3) reference date(s) and start and stop times of sample collection and analysis;
4) identification of the required radionuclides and other detected radionuclides;
5) sample type;
6) sample preservation;
7) date of sample receipt by service laboratory;
8) condition of package;
b) quantification of sample activity at the time of measurement, taking account of appropriate blanks and
correction factors (e.g. analysis of creatinine);
c) estimates of counting uncertainty and the total propagated uncertainty (depending on the client's
prescription);
d) identification of equipment and specific measurement procedures;
e) values of the decision threshold and detection limit;
f) identification of the individual responsible for the report.
The service laboratory shall retain, in a retrievable form, records required by this International Standard.
These records shall include for a period of time specified by national legal requirements or as long as they
remain current.
14.2 Reporting results for in vivo measurements
The results obtained by the service laboratory shall be reported and shall include the following items as a
minimum:

ISO/DIS 16637
a) subject identification;
b) date and (as appropriate) time of measurement;
c) identification of detected radionuclides;
d) identification of specific measurement procedures and equipment;
e) quantification of the amount of each radionuclides measured in each part of the body counted at the time
of measurement;
f) estimates of counting uncertainty and the total propagated uncertainty (depending on the client's
prescription);
g) values of the decision threshold and detection limit;
h) the value of the customer-specified or service laboratory action level for prompt notification;
i) identification of the individual responsible for the report.
The service laboratory shall retain, in a retrievable form, records required by this International Standard.
14.3 Documentation of the dose assessment
Arrangements shall be made to ensure that the results of all assessments are reported to the client's dose
record-keeping service accurately and in reasonable time.
Sufficient records shall be kept of the details of all assessments so that the exact conditions of assessment
may be reproduced in the future. All reports and records shall be authenticated by the Radiation Protection
Expert. Account shall be taken of the national requirements in respect of record-keeping.
Each assessment shall have:
a) a unique identification of dose assessment for one person and for one event;
b) the physical and chemical properties of compounds manipulated (compound, AMAD, etc.);
c) identification of the required radionuclides and other detected radionuclides;
d) the date and time of the measurements and quantities measured;
e) the route of intake(s);
f) the procedure for calculating doses: assumptions made in respect of temporal pattern of intake, default or
specific value of AMAD, chemical and physical nature of the radioactive aerosol, together with
assumptions on the absorption type;
g) the way of dose calculation; manually or with a computer software;
h) the results expressed in terms of committed effective dose from intakes of each radionuclide arising
during the monitoring interval. All doses shall be given in units of millisieverts correct to one decimal
place;
i) uncertainties only if explicitly requested by the customer shall be reported.
Arrangements for reporting to national authorities have to be made where required by national legislation.

ISO/DIS 16637
Annex A
Example of dj estimation
(informative)
The following additional factors may be taken into account to estimate the decision factor (dj)
 fworkload fraction of time involved in a particular task by the worker in the scenario. It is defined by the
Radiation Safety Officer according to the time assigned to the task. Its value is 1
 fhandled_activity fraction of the total activity that is handled by the worker in a scenario considering that in
real practice each worker, according to his responsibilities, could manipulate only a fraction of the total
activity in the specific area. Its value is 1
 fintake fraction of the handled activity that could be incorporated by the worker through aerolization or
volatization. The value 1×10-4 is assigned assuming a conservative approach to represent the potential
intake from the handled activity
Equation (3) is modified as follow:
A j  e j 50  f fS  f hS  f pS  f workload  f handled activity  f int ake

dj  (A.1)
10 3
And the simplified equation (4) is:
d j  10A j  e j 50 f hS  f pS  f workload  f handled activity  f int ake (A.2)

ISO/DIS 16637
Bibliography
[1] International Commission on Radiological Protection (ICRP), Radiological protection of the worker in
medicine and dentistry, ICRP Report 57. Pergamon Press, New York, 1989
[2] International Commission on Radiological Protection (ICRP), Dose coefficients for intakes of
radionuclides by workers, ICRP Report 68, Pergamon Press, New York ,1995
[3] International Commission on Radiological Protection (ICRP), Radiation dose for patients from
radiopharmaceuticals, ICRP Report 53, Pergamon Press, New York ,1987
[4] International Atomic Energy Agency (IAEA), Assessment of occupational exposures due to intakes of
radionuclides – IAEA Safety Guide No.RS-G-1.2, IAEA, Vienna, 1999
[5] ROJO, A., DANTAS, B. LOPEZ, G., NAVARRO, T., CRUZ SUAREZ, R. Application of IAEA criteria for
internal monitoring of occupationally exposed workers of nuclear medicine, memories IRPA 12, 2008
[6] DANTAS, B.M., LUCENA, E.A., DANTAS, A.L.A., Internal exposure in nuclear medicine: application of
IAEA criteria to determine the need for internal monitoring. Brazilian Archives of Biology and
technology, Vol. 51, No. special, pp 103-107, 2008
[7] BENTO, J., TELES, P., NEVES, N., SANTOS, A.I., CARDOSO, G., BARRETO, A., ALVES, F.,
GUERREIRO, C., RODRIGUES, A., SANTOS, J.A.M., CAPELO., C., PARAFITA, R., MARTINS, B.,
Study of nuclear medicine practices in Portugal from in internal dosimetry perspective. Radiation
Protection Dosimetry, Vol.149, No. 4, pp. 438-443, 2011
[8] International Commission on Radiological Protection, Nuclear Decay Data for Dosimetric Calculations,
Publication 107, Volume 38 Issue 3, 2008.
[9] LUCENA, E.A., REBELO, A.M.O., ARAUJO, F., SOUSA, W.O., DANTAS, A.L.A., DANTAS, B.M.,
CORBO, R., Evaluation of internal exposure of nuclear medicine staff through in vivo and in vitro
bioassays techniques. Radiation Protection Dosimetry, Vol.127, Nos. 1-4, pp. 465-468, 2007
[10] VIDAL, M.V.S., DANTAS, A.L.A., DANTAS, B.M., A methodology for auto-monitoring of internal
contamination by 131I in nuclear medicine workers. Radiation Protection Dosimetry, Vol.125, No. 1-4,
pp. 483-487, 2007
[11] LORAH, B., KING, S., ACHEY, B., A reevaluation of the procedures used to perform thyroid bioassay
on nuclear medicine personnel following radioiodine handling procedures. Health Physics, Vol. 102,
suppl.2,S60-S62, 2012
[12] International Commission on Radiological Protection (ICRP), Human respiratory tract model for
radiological protection, ICRP Report 66, Pergamon Press, New York, 1994
[13] International Commission on Radiological Protection (ICRP), Individual monitoring for internal
exposures of workers. ICRP report 78. Pergamon Press, New York, 1997
[14] BAECHLER, S., STRITT, N., BOCHUD, F.O. Individual monitoring of internal exposure for nuclear
medecine workers in Switzerland. Radiation Protection Dosimetry, Vol.144, No. 1-4, pp. 464-467, 2011
[15] BOSCHUNG, M., EIKENBERG, J., WERNLI, C., Incorporation measurements in Switzerland: the
approved internal dosimetry service at PSI. Radiation Protection Dosimetry, Vol.105, Nos. 1-4, pp.
351-354, 2003

ISO/DIS 16637
[16] OLIVEIRA, C.M., LIMA, F.F., DE OLIVEIRA, M.L., DA SILVA, T.V., DANTAS, A.N., DANTAS, B.M.,
ALONSO, T.C., DA SILVA, T.A. Evaluation of a technique for in vivo internal monitoring of 18F within a
brazilian laboratory network. Radiation Protection Dosimetry, Vol.153, No. 1, pp. 100-105, 2013
[17] FRANCK, D., BERNIERE, J., VILTARD, D., PARRE, F., CHALLETON-DE VATHAIRE, C.,
AGARANDE, M. Development of two mobile laboratories for a routine and accident monitoring of
internal contamination. Applied Radiation and Isotopes 70 pp. 1095–1099, 2012
[18] DANTAS, B.M., LUCENA, E.A., DANTAS, A.L.A., SANTOS, M.S. JULIAO, L.Q.C., MELO, D.R.,
SOUSA, W.O., FERNANDES, P.C., MESQUITA, S.A. A mobile bioassay laboratory for the
assessment of internal doses based on in vivo and in vitro measurements. Health Physics, Vol. 99,
No. 4, pp. 449-452, 2010
[19] WASSILIEFF S., CAZOULAT A., BOHAND S., MERAT F., GONTIER E., GAGNA G., AMABILE
J.-CAND and LAROCHE P. Assessment of internal exposure to ionizing radiations of the nuclear
medicine department staff in the Val-de-Grâce military hospital. Archives des maladies
professionnelles et de l’environnement, 73, 6, 860-867, 2012

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Draft for Public Comment

BSI Group Headquarters

Responsible committee: NCE/2 Radiation protection and measurement

Responsible Committee Secretary: Mr A Richards (BSI)

1 2 (3) 4 5 (6) (7)

No./Annex Figure/ ment MB comment submitted

(e.g. 3.1) Table/Note

The use of the UV photometer as an

alternative cannot be supported as

Delete reference to UV photometer.

serious problems have been encountered in its

use in the UK.

ISO/TC 85/SC 2 Secretariat: AFNOR

Radiological protection — Monitoring and internal

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Violators may be prosecuted.

ii © ISO 2013 – All rights reserved

© ISO 2013 – All rights reserved iii

13.5 Quality assurance of the assessment process ............................................................................... 27

iv © ISO 2013 – All rights reserved

© ISO 2013 – All rights reserved v

vi © ISO 2013 – All rights reserved

Radiological protection — Monitoring and internal dosimetry for

This International Standard addresses the following items:

a) purposes of monitoring and of 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;

i) assumptions for the selection of dose-critical parameter values;

j) criteria for determining the significance of monitoring results;

k) interpretation of workplace monitoring results;

l) uncertainties arising from dose assessments and interpretation of bioassays data;

This International Standard does not address

© ISO 2013 – All rights reserved 1

 detailed descriptions of measuring methods and techniques;

 dosimetry for litigation cases;

 modelling for the improvement of internal dosimetry;

 the potential influence of medical treatment of the internal contamination;

 the investigation of the causes or implications of an exposure;

 dosimetry for ingestion exposures.

ISO 28218:2010, Radiation protection — Performance criteria for radiobioassay

3 Terms and definitions

2 © ISO 2013 – All rights reserved

© ISO 2013 – All rights reserved 3

4 © ISO 2013 – All rights reserved

© ISO 2013 – All rights reserved 5

4 Symbols and abbreviated terms

AMAD Activity median aerodynamic diameter

dj Decision factor for radionuclide j (mSv)

D Decision factor for all radionuclides in the workplace (mSv)

DRL Derived recording level

E(50) Committed effective dose (Sv)

Twork Time spends by the worker in the radioactive atmosphere (h)

6 © ISO 2013 – All rights reserved

5.2 Assessment of the level of likely exposures

 radioiodine treatment rooms and adjacent areas;