IEC 63465:2026

IEC 63465 ®
Edition 1.0 2026-01
INTERNATIONAL
STANDARD
Calibration and quality control in the use of radionuclide calibrators

ICS 11.040.50  ISBN 978-2-8327-0560-5

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CONTENTS
FOREWORD . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions, abbreviated terms and symbols, quantities, and units . 6
3.1 Terms and definitions . 6
3.2 Abbreviated terms and symbols. 14
3.3 Quantities and units . 14
4 Installation and calibration of radionuclide calibrators . 14
4.1 Principles of operation (informative) . 14
4.2 Installation and operation . 15
4.3 Initial calibration by manufacturer . 15
4.4 Subsidiary calibration . 16
5 General considerations . 16
5.1 Instrument classification . 16
5.2 Marking . 16
5.3 Measurement conditions . 16
5.4 Radioactive sources for calibration and QC . 17
5.4.1 Certified and traceable radioactive standard sources . 17
5.4.2 Check sources . 17
5.4.3 Simulated sources . 17
6 Performance requirements and frequency of tests . 18
6.1 General . 18
6.2 Visual review . 19
6.2.1 General. 19
6.2.2 Procedure . 19
6.2.3 Recommended frequency . 19
6.2.4 Acceptance criteria . 20
6.3 Date and time settings . 20
6.3.1 General. 20
6.3.2 Procedure . 20
6.3.3 Recommended frequency . 20
6.3.4 Acceptance criteria . 20
6.4 Background test . 20
6.4.1 General. 20
6.4.2 Procedure . 20
6.4.3 Recommended frequency . 21
6.4.4 Acceptance criteria . 21
6.5 Bias current compensation (if applicable to the instrument model) . 21
6.5.1 General. 21
6.5.2 Procedure . 22
6.5.3 Recommended frequency . 22
6.5.4 Acceptance criteria . 22
6.6 High voltage . 22
6.6.1 General. 22
6.6.2 Procedure . 22
6.6.3 Recommended frequency . 22
6.6.4 Acceptance criteria . 22
6.7 Constancy test . 22
6.7.1 General. 22
6.7.2 Procedure . 23
6.7.3 Recommended frequency . 23
6.7.4 Acceptance criteria . 24
6.8 Repeatability . 24
6.8.1 General. 24
6.8.2 Procedure . 24
6.8.3 Recommended frequency . 24
6.8.4 Acceptance criteria . 24
6.9 Reproducibility . 25
6.9.1 General. 25
6.9.2 Procedure . 25
6.9.3 Recommended frequency . 25
6.9.4 Acceptance criteria . 25
6.10 Linearity test . 26
6.10.1 General. 26
6.10.2 Procedure . 26
6.10.3 Recommended frequency . 27
6.10.4 Acceptance criteria . 27
6.11 Accuracy . 27
6.11.1 General. 27
6.11.2 Procedure . 27
6.11.3 Recommended frequency . 28
6.11.4 Acceptance criteria . 28
7 Documentation requirements . 29
7.1 General . 29
7.2 User manual. 29
7.3 Documentation . 29
7.4 Declaration of performance . 30
8 Special considerations during measurements . 30
8.1 General . 30
8.2 Radioactive impurities . 30
8.3 Time dependent calibration settings. 30
8.4 Beta minus emitters . 30
8.5 Low-energy photon emitters . 31
8.6 Source height . 31
8.7 Residual activity . 31
8.8 Density of solution . 32
8.9 Microparticles . 32
8.10 Additional lead shielding . 32
8.11 Measurement of low activity sources. 32
9 Sources of uncertainty . 33
10 Sources of measurement bias or error . 33
Annex A (informative) Installation and operation . 36
A.1 Installation preparation phase . 36
A.2 Receipt and commissioning . 36
A.2.1 General information. 36
A.2.2 Unpacking and checking the integrity of the equipment . 37
A.2.3 Opening and keeping the record book of the radionuclide calibrator . 37
A.2.4 Power-up and functional check . 37
A.2.5 Listing of radionuclides and reference geometries . 38
A.2.6 Commissioning tests . 38
A.2.7 Development of QC procedures and QMS . 38
A.3 Recommendations for use . 39
A.3.1 Before use . 39
A.3.2 During use . 39
A.3.3 After use . 39
A.4 Examples of QC tests, recording and evaluation of results . 39
A.4.1 Example form for daily QC log . 39
A.4.2 Example for control chart . 41
A.4.3 Example for linearity test . 41
Annex B (informative) Subsidiary calibrations: determination of new calibration
settings and correction factors . 43
B.1 General . 43
B.2 Technical considerations . 43
B.3 Protocol for the case when the reference source geometry matches the
expected measurement geometry . 44
B.4 Protocols for the case when the reference source geometry differs from the
expected measurement geometry . 44
B.5 Protocol for different shielding. 45
B.6 Protocol for determining correction factors for solution density . 46
B.7 Uncertainties associated with subsidiary calibrations . 46
Bibliography . 47

Figure A.1 – Control chart established for evaluating daily background response
measurements . 41

Table 1 – Summary of performance requirements for routine QC and frequency of tests . 18
Table A.1 – Example form for daily QC log . 40

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Calibration and quality control in the use of radionuclide calibrators

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 63465 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear
medicine and radiation dosimetry, of IEC technical committee 62: Medical equipment, software,
and systems. It is an International Standard.
ISO/WD 23557 has served as a basis for the elaboration of this document.
This first edition cancels and replaces IEC TR 61948-4:2019, IEC 61303:1994,
IEC 61145:1992. This edition constitutes a technical revision.
___________
This project has been cancelled.
This edition includes the following significant technical changes with respect to
IEC TR 61948-4:2019, IEC 61303:1994 and IEC 61145:1992:
a) technical specifications and quality control procedures are updated to apply to modern
instruments;
b) test acceptance criteria are defined for reference class and field class devices;
c) recommendations are given on recording and logging of test data, including the use of
control charts;
d) specific calibration guidance is included, including guidance for subsidiary calibrations with
end-user-defined source geometries.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/959/FDIS 62C/969/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
1 Scope
This document specifies the techniques for calibration and usage of pressurised, well-type
ionisation chambers for activity measurements of radioactive sources. Such instruments are
used to determine the activity, expressed in becquerel (Bq), of photon and some medium to
high-energy beta-emitters.
This document addresses calibration procedures of ionisation chambers and radionuclide
calibrators to be used by equipment manufacturers, national metrology institutes and
designated institutes, radionuclide producers, suppliers, distributors, and end users, like
nuclear medicine facilities, industrial or hospital (radio)pharmacies, research laboratories, and
nuclear power plants.
This document provides the methods and tests for establishing conformity of device
acceptability and maintaining acceptable instrument performance. Performance benchmarks
vary depending on the application, so information is given specific to field class instruments for
end users and reference class instruments for standards laboratories and instrument
manufacturers.
The ionisation chamber or radionuclide calibrator can be an instrument that is used as a
standalone device, but it can also be integrated in a much larger appliance, such as a laminar
air flow cabinet, a fume hood, a hot cell, or a dispensing unit. The instrument can also be
equipped with accessories that are essential for the intended use of the appliance that
surrounds and incorporates the radionuclide calibrator. The proper use of each of the
accessories can be important for the correct use of the radionuclide calibrator and therefore is
part of the scope of this document.
The software and computer system(s) that can be used to control the radionuclide calibrator
hardware and functioning are considered an integral part of the device and therefore are also
considered part of the scope of this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60050-395, International Electrotechnical Vocabulary (IEV) - Part 395: Nuclear
instrumentation - Physical phenomena, basic concepts, instruments, systems, equipment and
detectors, available at www.electropedia.org
3 Terms and definitions, abbreviated terms and symbols, quantities, and units
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60050-395 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
– IEC Electropedia: available at https://www.electropedia.org/
– ISO Online browsing platform: available at https://www.iso.org/obp
3.1.1
acceptance criteria
numerical limits, ranges, or other suitable measures for acceptance of test results
[SOURCE: ISO 22716:2007, 2.1]
3.1.2
accuracy
quality which characterizes the ability of a measuring instrument to provide an indicated value
close to a true value of the measurand
[SOURCE: IEC 60050-311:2001, 311-06-08, modified – The domain and the notes were
deleted.]
3.1.3
background radiation
ionizing radiation from any origin, natural or artificial, other than the radiation it is desired to
detect or measure
[SOURCE: IEC 60050-881:1983, 881-02-13, modified – The second term "ambient radiation"
was deleted.]
3.1.4
background response
response of the instrument in the absence of a radioactive source to be measured
Note 1 to entry: A background response is caused by a background radiation in addition to any electronic noise or
contamination.
3.1.5
beta particle
electron or positron which has been emitted by an atomic nucleus or neutron in a nuclear
transformation
[SOURCE: ISO 921:1997, definition 81]
3.1.6
beta-emitter
material, the nuclei of which emit beta particles
Note 1 to entry: It is possible to classify beta emitters by the maximum energy level of the particles that they release
during their disintegration.
Note 2 to entry: When the beta particle emitted is an electron, the beta-emitter is called "beta minus emitter". When
the beta particle emitted is a positron, the beta-emitter is called "beta plus emitter", resulting in the emission of
photons of 511 keV.
[SOURCE: ISO 3543:2000, 2.3, modified – The terms "beta-emitting isotope" and "beta-emitting
source" were deleted and Note 2 was replaced with a new note to entry.]
3.1.7
calibration
set of operations which establishes, by reference to standards, the relationship which exists,
under specified conditions, between an indication and a result of a measurement
[SOURCE: IEC 60050-311:2001, 311-01-09, modified – The notes were deleted.]
3.1.8
calibration coefficient
multiplicative value that converts a measurement signal to the measurand of interest
Note 1 to entry: In the case of radionuclide calibrators, the measurement signal is the current and the measurand
of interest is the activity.
3.1.9
calibration setting
instrument setting that converts measured current to a displayed activity
Note 1 to entry: A calibration setting was historically referred to as "dial setting".
3.1.10
certified radioactive standard source
radioactive source that has been calibrated by a laboratory recognized as a country’s national
standardizing laboratory for activity measurements and has been certified by the
aforementioned laboratory
[SOURCE: IEC 60050-395:2014, 395-02-03, modified – The noun "radioactivity" was replaced
with "activity". The word "so" was removed, as well as the note to entry.]
3.1.11
check source
long-lived radionuclide used to check the constancy of the radionuclide calibrator
3.1.12
combined standard uncertainty
standard uncertainty of the result of a measurement when that result is obtained from the values
of a number of other quantities, equal to the positive square root of a sum of terms, the terms
being the variances or covariances of these other quantities weighted according to how the
measurement result varies with changes in these quantities
[SOURCE: IEC 60076-19-1:2023, 3.3]
3.1.13
commissioning test
test on an item carried out on site, to prove that it is correctly installed and can operate correctly
[SOURCE: IEC 60050-151:2001, 151-16-24]
3.1.14
correction factor
numerical factor by which the uncorrected result of a measurement at the measured conditions
is multiplied
Note 1 to entry: For radionuclide calibrator, correction factors to reference conditions are used to take account of
differences in the measurement conditions between calibration conditions and those used by the end user
[SOURCE: ISO 8222:2020, 3.1.8 modified – Note 1 to entry was adapted to radionuclide
calibrator.]
3.1.15
decay constant
λ
disintegrations per unit time dN/dt for an atomic nucleus divided by the number of nuclei N
existing at the same time t
1dN
λ= − ×
Ntd
−1
Note 1 to entry: The decay constant is expressed in reciprocal seconds (s ).
Note 2 to entry: The decay constant represents the probability of decay in the limit of small time intervals.
[SOURCE: IEC 60050-395:2014, 395-01-11, modified – Note 2 to entry was modified and Note
3 to entry was deleted.]
3.1.16
decay correction
method for calculating the activity at a given time based on the decay
A = A exp(–λt )where
t 0 e
A is the activity at a reference time t ;
0 0
A is the activity at a given time t;
t
λ is the decay constant of the radionuclide of interest;
t is the elapsed time (expressed in s), where t = t – t and can be positive (decrease in
e e 0
activity compared with the reference time) or negative (increase in activity compared with
the reference time)
Note 1 to entry: It is important to use the correct decay constant to determine the decay correction value.
3.1.17
error
error of measurement
measurement error
measured quantity value minus a reference quantity value
[SOURCE: ISO 17123-1:2014, 3.1.12]
3.1.18
expanded uncertainty
U
quantity defining an interval about the result of a measurement that can be expected to
encompass a large fraction of the distribution of values that can reasonably be attributed to the
measurand
U= ku
c
where
u is the combined standard uncertainty of a result of a measurement;
c
k is the coverage factor defined as the numerical factor used as a multiplier of the combined
standard uncertainty (see ISO ISO/IEC Guide 98-3)
[SOURCE: IEC 60076-19-1:2023, 3.4, modified – The symbol "U" and the formula were added.]
3.1.19
field class instrument
radionuclide calibrator used in nuclear medicine facilities, industrial or hospital
(radio)pharmacies, research laboratories, and nuclear power plants
3.1.20
human error
discrepancy between the human action taken or omitted, and that intended or required
EXAMPLE Performing an incorrect action; omitting a required action; miscalculation; misreading a value.
[SOURCE: IEC 60050-192:2015, 192-03-14]
3.1.21
linearity
ability of a measuring instrument to provide an indication having a
linear relationship with a defined quantity other than an influence quantity
Note 1 to entry: With radionuclide calibrators, the measured current has a linear relationship with the source activity.
[SOURCE: IEC 60050-311:2001, 311-06-05, modified – Note 1 to entry was adapted to
radionuclide calibrators.]
3.1.22
measurand
particular quantity subject to measurement
[SOURCE: IEC 60050-311:2001, 311-01-03]
3.1.23
measurement
process of experimentally obtaining one or more values that can reasonably be attributed to a
quantity
Note 1 to entry: Measurement does not apply to nominal properties.
Note 2 to entry: Measurement implies comparison of quantities, including counting of entities.
[SOURCE: ISO/IEC Guide 99:2007, 2.1, modified – The words "quantity values" were replaced
with "values", and Note 3 to entry was deleted.]
3.1.24
measurement bias
bias
estimate of a systematic measurement error
[SOURCE: ISO/IEC Guide 99:2007, 2.18]
3.1.25
measurement geometry
geometry
physico-chemical properties of the source, its container, the
environment, and the accessories used for measurement
Note 1 to entry: Physico-chemical properties include the following:
• for the source, the volume, density, composition (example: microparticles), etc.;
• for the container and the accessories, the atomic composition (example: glass or plastic);
• for the environment, the ambient conditions (example: temperature, relative humidity), and shielding.
3.1.26
multiplication factor
numeric scaling factor that is part of the calibration by which the radionuclide calibrator reading
is to be multiplied to calculate the true activity of a source
Note 1 to entry: Commonly expressed as, for example, "450 × 10", meaning that the instrument reading with a
calibration setting of 450 is multiplied by a factor of 10 to give the true activity.
Note 2 to entry: In many modern instruments, multiplication factors can be applied in software.
3.1.27
quality assurance
QA
planned, systematic, and preventive actions that are required to ensure that materials, products,
or services meet specified requirements
[SOURCE: ISO 13628-2:2006, 3.34, modified – The abbreviated term "QA" has been added.]
3.1.28
quality control
QC
inspection, test or examination to ensure that materials, products or services conform to
specified requirements
Note 1 to entry: Additional information can be found in ISO/IEC 17025 [1].
[SOURCE: ISO 13628-2:2006, 3.35, modified – The abbreviated term "QC" and Note 1 to entry
were added.]
3.1.29
quality management system
QMS
part of a management system with regard to quality
Note 1 to entry: The QMS is presented here as a framework described by ISO 9000 and ISO 9001 and comprises
three core elements: quality control, quality assurance and quality improvement.
[SOURCE: ISO 9000:2015, 3.5.4, modified – The abbreviated term "QMS" and Note 1 to entry
were added.]
3.1.30
radioactive impurities
radionuclides in a radioactive source other than the principal radionuclide
3.1.31
radionuclidic purity
ratio, expressed as percentage, of the activity of the desired radionuclide to the total activity of
the source
3.1.32
radioactive source
radioactive material which is intended for use as a source of ionising radiation
[SOURCE: IEC 60050-881:1983, 881-06-02, modified – The phrase "any quantity of" was
removed.]
3.1.33
radionuclide calibrator
re-entrant pressurised ionisation chamber with associated electronics used to measure current
produced by a radioactive source and display in units of activity
3.1.34
reference clock
clock of very high stability, accuracy, and reliability which is used as the single reference
standard for the clocks in a synchronized network
[SOURCE: IEC 60050-704:1993, 704-13-10]
3.1.35
reference device
device, which is calibrated against national standards, possessing accurately known
parameters used for calibrating secondary devices
3.1.36 ISO
reference geometry
measurement geometry used during a calibration
Note 1 to entry: Radioactive sources must be prepared as close as possible to the reference geometry to avoid the
use of corrections and/or inaccurate activity measurements.
3.1.37
reference volume
volume of radioactive solution in the container for which the calibration
was performed
3.1.38
repeatability
closeness of agreement between the results of successive
measurements of the same measurand, carried out under the same conditions of measurement,
i.e.:
– by the same measurement procedure,
– by the same observer,
– with the same measuring instruments, used under the same conditions,
– in the same laboratory,
– at relatively short intervals of time
Note 1 to entry: The concept of "measurement procedure" is defined in ISO/IEC Guide 99:2007, 2.6.
[SOURCE: IEC 60050-311:2001, 311-06-06]
3.1.39
reproducibility
< measurements> closeness of agreement between the results of measurements of the same
value of a quantity, when the individual measurements are made under different conditions of
measurement:
– principle of measurement;
– method of measurement;
– observer;
– measuring instruments;
– reference standards;
– laboratory;
– under conditions of use of the instruments, different from those customarily used;
– after intervals of time relatively long compared with the duration of a single measurement
Note 1 to entry: The concepts of “measurement principle” and “measurement method” are respectively defined in
ISO/IEC Guide 99:2007, 2.4 and 2.5.
Note 2 to entry: The term “reproducibility” also applies to the instance where only certain of the above conditions
are taken into account, provided that these are stated.
[SOURCE: IEC 60050-311:2001, 311-06-07]
3.1.40
simulated source
mock source
long-lived radionuclide, used alone or in combination with others to simulate, in terms of photon
or particle emission, a short-lived radionuclide of interest
[SOURCE: IEC 60050-395:2014, 395-02-06, modified – The term "mock source" was added
and Note 1 to entry was deleted.]
3.1.41
source geometry
physico-chemical characteristics of a radioactive source measured on
a radionuclide calibrator, including its volume, density, and composition (example:
microparticles), and the type and composition of the container used
Note 1 to entry: Deviation from the source geometry can result in inaccurate activity measurements.
3.1.42
traceable radioactive standard source
radioactive source that has been calibrated by comparing it to a certified radioactive standard
source or to another standardized radioactive source of the same radionuclide
[SOURCE: IEC 60050-394:2014, 395-02-04, modified - Note 1 to entry was deleted.]
3.1.43
traceability
property of the result of a measurement or of the value of a standard such that it can be related
to stated references, usually national or international standards, through a documented
unbroken chain of calibrations, all having stated uncertainties
Note 1 to entry: The concept is often expressed by the adjective traceable.
Note 2 to entry: The unbroken chain of comparisons is called a traceability chain.
[SOURCE: IEC 60050-311:2001, 311-01-15, modified – The word "documented" was added and
the word “comparisons” was replaced with “calibrations”. Note 3 to entry was deleted.]
3.1.44
uncertainty
parameter, associated with the result of a measurement, that characterizes
the dispersion of the values that could reasonably be attributed to the measurand
Note 1 to entry: Various ways to estimate uncertainty are defined in ISO/IEC Guide 98-3.
Note 2 to entry: Uncertainty of measurement comprises, in general, many components. Some of these components
can be evaluated from the statistical distribution of the results of a series of measurements and can be characterized
by experimental standard deviations. Other components, which can also be characterized as standard deviations,
are evaluated from the assumed probability distributions based on experience or other information.
[SOURCE: IEC 60050-311:2001, 311-01-02, modified – Note 1 to entry was deleted and Notes
2 and 3 to entry were modified.]
3.1.45
user manual
document provided by the manufacturer that describes how to use a functional unit, and that
can include description of the rights and responsibilities of the user, the owner, and the supplier
of the unit
Note 1 to entry: The user manual is often labelled “user guide”, "owner's manual" or "operator's manual".
[SOURCE: ISO/IEC 2382:2015, modified – The notes to entry were replaced with a new note
to entry.]
3.2 Abbreviated terms and symbols
SI International System
3.3 Quantities and units
In this document, the International System of Units is used [2] .
The following units for time are used:
– days (symbol: d);
– hours (symbol: h);
– minutes (symbol: min);
– seconds (symbol: s).
Multiples and submultiples of SI units are used, when practicable, according to the SI system.
The definitions of radiation quantities are given in IEC 60050-395.
4 Installation and calibration of radionuclide calibrators
4.1 Principles of operation (informative)
Radionuclide calibrators are based on ionisation chambers that generate a radionuclide-
dependent current proportional to the source's activity. They are calibrated to determine
calibration coefficients or, more commonly, define calibration settings to convert the measured
current into an activity for a given radionuclide. Furthermore, ionisation current and thus activity
measurement depends on the measurement geometry (see Clause 8) [3].
___________
Numbers in square brackets refer to the Bibliography.
4.2 Installation and operation
The instrument shall be installed and operated in accordance with the manufacturer’s
instructions. Local regulations can also possibly apply. Additional information regarding
installation and operation is provided in Annex A.
4.3 Initial calibration by manufacturer
A radionuclide calibrator is usually supplied with calibration settings for the most commonly
used radionuclides in a specified reference geometry (see 4.4). This initial calibration is
developed for a specific radionuclide calibrator (a reference device) and should be traceable to
a primary standard laboratory. Details of the calibration should be provided to the end user
(typically through energy-dependent response curves) by the instrument manufacturer.
Manufacturers calibrate reference devices by direct measurement with as many certified
radioactive standard sources (often referred to as “certified reference sources” or “standard
reference sources”) as possible. If certified radioactive standard sources are not reasonably
accessible, certified radioactive standard sources may be substituted by traceable radioactive
standard sources. For radionuclides for which certified radioactive standard sources or
traceable radioactive sources are not reasonably accessible, the manufacturer can provide a
calculated value based on energy-dependent response curves and published radionuclide
decay data ([4], [5]). The manufacturer should clearly state in the provided documentation the
conditions of the initial calibration of the reference device as direct measurement or calculated
value and clearly specify the reference geometry (see also 7.3).
These initial calibrations are then transferred as calibration settings to production units. Reliable
calibration depends upon reproducible physical specifications. Therefore, the manufacturer
should assure that all production chambers strictly conform to stated material specifications,
physical dimensions, and tolerances. Some manufactu
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