IEC 61674:2024
(Main)Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY;
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed;
d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices
Appareils électromédicaux - Dosimètres à chambres d'ionisation et/ou à détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
L'IEC 61674:2024 spécifie les exigences de performance, et quelques exigences de construction associées, des dosimètres de radiodiagnostic destinés au mesurage du kerma dans l'air, du produit kerma dans l’air longueur ou du débit de kerma dans l’air, dans des champs de rayonnement de photons utilisés en imagerie médicale à rayonnement X, telle que la radiographie, la radioscopie et la tomodensitométrie (CT), pour des rayonnements X dont les potentiels se situent dans la plage comprise entre 20 kV et 150 kV. Le présent document est applicable à la performance des dosimètres à chambres d’ionisation ouvertes et/ou à détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X. L'IEC 61674:2024 annule et remplace la deuxième édition de l’IEC 61674 parue en 2012. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) pour la mammographie, le fabricant spécifie la valeur de référence pour la qualité de rayonnement;
b) pour la mammographie, le fabricant fournit le domaine assigné minimal des qualités de rayonnement pour l’essai de conformité pour la dépendance de la réponse en énergie;
c) l’essai de conformité pour les affichages analogiques a été supprimé;
d) les essais de conformité relatifs à la remise à zéro dans les plages, à l’effet du courant de fuite et aux pertes de recombinaison ont été supprimés. Ces essais sont déjà couverts par l’essai de linéarité et ne peuvent pas être réalisés sur les dispositifs modernes. L’estimation de l’incertitude normalisée combinée a été modifiée en conséquence;
e) l’essai de conformité pour les dosimètres fonctionnant sur batterie rechargeable par le réseau a été mis à jour pour les dispositifs modernes.
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Standards Content (Sample)
IEC 61674 ®
Edition 3.0 2024-07
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
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IEC 61674 ®
Edition 3.0 2024-07
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-9379-9
– 2 – IEC 61674:2024 CMV © IEC 2024
CONTENTS
FOREWORD .4
INTRODUCTION .7
1 Scope and object .8
1.1 Scope .8
1.2 Object .8
2 Normative references .8
3 Terms and definitions .9
4 General requirements . 17
4.1 Performance requirements . 17
4.2 REFERENCE VALUES and STANDARD TEST VALUES . 17
4.3 General test conditions . 18
4.3.1 STANDARD TEST CONDITIONS . 18
4.3.2 Statistical fluctuations . 18
4.3.3 STABILIZATION TIME . 19
4.3.4 Adjustments during test . 19
4.3.5 Batteries . 19
4.4 Constructional requirements as related to performance . 19
4.4.1 Components . 19
4.4.2 Display . 20
4.4.3 Indication of battery condition . 20
4.4.4 Indication of polarizing voltage failure . 20
4.4.5 Over-ranging . 20
4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 21
4.4.7 Radioactive STABILITY CHECK DEVICE . 21
4.5 UNCERTAINTY of measurement . 21
5 Limits of PERFORMANCE CHARACTERISTICS . 22
5.1 Linearity . 22
5.2 Repeatability . 22
5.2.1 General . 22
5.2.2 Repeatability in the ATTENUATED BEAM . 22
5.2.3 Repeatability in the UNATTENUATED BEAM. 23
5.3 RESOLUTION of reading . 23
5.4 STABILIZATION TIME . 23
5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 24
5.6 Stability . 25
5.6.1 Long term stability . 25
5.6.2 Accumulated dose stability. 25
5.6 Reset on AIR KERMA and AIR KERMA LENGTH PRODUCT ranges .
5.7 Effects of LEAKAGE CURRENT .
5.7 Measurements with a radioactive STABILITY CHECK DEVICE . 25
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 26
6.1 General . 26
6.2 Energy dependence of RESPONSE . 26
6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 28
6.3.1 MEASURING ASSEMBLY .
6.3.2 IONIZATION CHAMBER – Recombination losses .
6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 29
6.4.1 Non-CT detectors . 29
6.4.2 CT DETECTORS . 29
6.5 Operating voltage . 29
6.5.1 Mains-operated DOSIMETERS. 29
6.5.2 Battery-operated DOSIMETERS . 29
6.5.3 Mains rechargeable, battery-operated DOSIMETERS . 30
6.6 Air pressure. 30
6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR. 30
6.8 Temperature and humidity . 31
6.9 Electromagnetic compatibility . 31
6.9.1 ELECTROSTATIC DISCHARGE . 31
6.9.2 Radiated electromagnetic fields . 32
6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies . 32
6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 32
6.10 Field size . 33
6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 33
7 Marking . 33
7.1 DETECTOR ASSEMBLY . 33
7.2 MEASURING ASSEMBLY . 33
7.3 Radioactive STABILITY CHECK DEVICE. 34
8 ACCOMPANYING DOCUMENTS . 34
Annex A (informative) Combined standard uncertainty for dosimeter performance . 36
Bibliography . 37
Index of defined terms . 38
List of comments . 41
Table 1 – REFERENCE and STANDARD TEST CONDITIONS . 17
Table 2 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 19
Table 3 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the attenuated beam . 23
Table 4 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the unattenuated beam and mammography . 23
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 27
Table 6 – Climatic conditions . 31
Table A.1 – Estimation of COMBINED STANDARD UNCERTAINTY for dosimeter performance . 36
– 4 – IEC 61674:2024 CMV © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR
DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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This commented version (CMV) of the official standard IEC 61674:2024 edition 3.0 allows
the user to identify the changes made to the previous IEC 61674:2012 edition 2.0.
Furthermore, comments from IEC SC 62C experts are provided to explain the reasons of
the most relevant changes, or to clarify any part of the content.
A vertical bar appears in the margin wherever a change has been made. Additions are in
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This publication contains the CMV and the official standard. The full list of comments is
available at the end of the CMV.
IEC 61674 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.
This third edition cancels and replaces the second edition published in 2012. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION
QUALITY; 1
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION
QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed; 2
d) the compliance tests for range reset, the effect of leakage and recombination losses were
removed. These tests are already covered by the test on linearity and cannot be conducted
for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed
accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated
for modern devices.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/909/FDIS 62C/913/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.
In this document, the following print types are used.
– requirements and definitions: roman type.
– test specifications: italic type.
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2:2021. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
– 6 – IEC 61674:2024 CMV © IEC 2024
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.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates
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INTRODUCTION
Diagnostic radiology is the largest contributor to man-made IONIZING RADIATION to which the
public is exposed. The reduction in the exposure received by PATIENTS undergoing medical
radiological examinations or procedures has therefore become a central issue in recent years.
The PATIENT dose will be minimized when the X-ray producing equipment is correctly adjusted
for image quality and radiation output. These adjustments require that the routine measurement
of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE be made accurately. The
equipment covered by this document plays an essential part in achieving the required accuracy.
It is important that the DOSIMETERS used for adjustment and control measurements must be are
of satisfactory quality and must therefore fulfil the special requirements laid down in this
document.
– 8 – IEC 61674:2024 CMV © IEC 2024
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR
DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
1 Scope and object
1.1 Scope
This document specifies the performance and some related constructional requirements of
DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT
or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as
RADIOGRAPHY, including mammography, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-
RADIATION with generating potentials not greater than in the range of 20 kV to 150 kV.
This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION
CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
1.2 Object
The object of this document is
a) to establish requirements for a satisfactory level of performance for DIAGNOSTIC DOSIMETERS,
and
b) to standardize the methods for the determination of compliance with this level of
performance.
DOSIMETERS. The DIAGNOSTIC
This document is not concerned with the safety aspects of
DOSIMETERS covered by this document are not intended for use in the PATIENT ENVIRONMENT
and, therefore, the requirements for electrical safety applying to them are contained in
IEC 61010-1.
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 (all parts), International Electrotechnical Vocabulary (available at
)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-ray
equipment
IEC 60417, Graphical symbols for use on equipment, available at http://www.graphical-
symbols.info/equipment
IEC 60731:2011, Medical electrical equipment – Dosimeters with ionization chambers as used
in radiotherapy
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61000-4 (all parts), Electromagnetic compatibility (EMC) – Part 4: Testing and measuring
techniques
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) – Part 4-2: Testing and
measurement techniques – Electrostatic discharge immunity test
IEC 61000-4-3:2020, Electromagnetic compatibility (EMC) – Part 4-3: Testing and
measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement
techniques – Electrical fast transient/burst immunity test
IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement
techniques – Immunity to conducted disturbances, induced by radio-frequency fields
IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement
techniques – Voltage dips, short interruptions and voltage variations immunity tests for
equipment with input current up to 16 A per phase
IEC 61187, Electrical and electronic measuring equipment – Documentation
IEC 61267:2005, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
-3:2008, Uncertainty of measurement – Part 3: Guide to the expression of
ISO/IEC GUIDE 98
uncertainty in measurement (GUM:1995)
ISO/IEC Guide 99:2007, International vocabulary of metrology – Basic and general concepts
and associated terms (VIM)
ISO 3534-1:2006, Statistics – Vocabulary and symbols – Part 1: General statistical terms and
terms used in probability
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC TR 60788:2004 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
DIAGNOSTIC DOSIMETER
DOSIMETER
equipment which uses IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS for the
measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE in the beam of
an X-RAY EQUIPMENT used for diagnostic medical radiological examinations
Note 1 to entry: A DIAGNOSTIC DOSIMETER contains the following components:
– one or more DETECTOR ASSEMBLIES which may or may not be an integral part of the MEASURING ASSEMBLY;
– a MEASURING ASSEMBLY;
– 10 – IEC 61674:2024 CMV © IEC 2024
– one or more STABILITY CHECK DEVICES (optional).
3.1.1
DETECTOR ASSEMBLY
RADIATION DETECTOR and all other parts to which the RADIATION DETECTOR is permanently
attached, except the MEASURING ASSEMBLY
Note 1 to entry: The DETECTOR ASSEMBLY normally includes:
– the RADIATION DETECTOR and the stem (or body) on which the RADIATION DETECTOR is permanently mounted (or
embedded);
– the electrical fitting and any permanently attached cable or pre-amplifier.
3.1.1.1
RADIATION DETECTOR
element which transduces AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE into a
measurable electrical signal
Note 1 to entry: A radiation detector may be either an ionization chamber or a semiconductor detector.
3.1.1.1.1
IONIZATION CHAMBER
CHAMBER
ionizing RADIATION DETECTOR consisting of a CHAMBER filled with air, a suitable gas, or a gaseous
mixture, in which an electric field insufficient to produce gas multiplication is provided for the
total collection, at the electrodes, of charges associated with the ions and the electrons
produced in the measuring sensitive volume of the detector by the ionizing radiation
Note 1 to entry: An ionization chamber can be sealed or vented.
Note 2 to entry: Vented ionization chambers are constructed in such a way as to allow the air inside the measuring
volume to communicate freely with the atmosphere, so that corrections to the response for changes in air density
need to be made.
Note 3 to entry: Sealed ionization chambers are not suitable, because the necessary wall thickness of a sealed
chamber may cause an unacceptable energy dependence of the response and because the long-term stability of
sealed chambers is not guaranteed.
[SOURCE: IEC 60731:2011, 3.1.1.1, modified – three new notes to entry have replaced the two
original notes. IEC 60050-395:2014, 395-03-07, modified – Two new notes to entry were
added.]
3.1.1.1.2
VENTED IONIZATION CHAMBER
IONIZATION CHAMBER constructed in such a way as to allow the air inside the measuring volume
to communicate freely with the atmosphere such that corrections to the RESPONSE for changes
in air density need to be made
[SOURCE: IEC 60731:2011, 3.1.1.1.3, modified – The term has been changed from "vented
chamber" to "VENTED IONIZATION CHAMBER".]
3.1.1.1.3
SEMICONDUCTOR DETECTOR
semiconductor device that utilises the production and motion of electron-hole pairs in a charge
carrier depleted region of the semiconductor for the detection and measurement of IONIZING
RADIATION
Note 1 to entry: The production of electron-hole pairs is caused either directly by interaction of the IONIZING
RADIATION with the semiconductor material, or. In the purview of this document 3, detectors qualify as semiconductor
detectors, even when the production of electron-hole pairs is caused indirectly by first converting the incident
radiation energy to light in a scintillator material directly in front of and optically coupled to a semiconductor
photodiode, which then produces the electrical signal.
3.1.2
MEASURING ASSEMBLY
device to measure the charge (or current) electrical signal from the RADIATION DETECTOR and
convert it into a form suitable for displaying the values of DOSE or KERMA or their corresponding
rates
2011, 3.1.2, modified – The term IONIZATION CHAMBER in the original
[SOURCE: IEC 60731:
definition has been replaced by the term RADIATION DETECTOR The words "measure the charge
(or current) from the IONIZATION CHAMBER" have been replaced with "measure the electrical
signal from the RADIATION DETECTOR".]
3.1.3
STABILITY CHECK DEVICE
device which enables the stability of RESPONSE of the MEASURING ASSEMBLY and/or CHAMBER
ASSEMBLY to be checked
Note 1 to entry: The STABILITY CHECK DEVICE may be a purely electrical device, or a radiation source, or it may
include both.
[SOURCE: IEC 60731:2011, 3.1.3]
3.1.4
CT DOSIMETER
DIAGNOSTIC DOSIMETER which uses long narrow IONIZATION CHAMBERS and/or SEMICONDUCTOR
DETECTORS for the measurement of AIR KERMA integrated along the length of the DETECTOR when
the DETECTOR is exposed to a cross-sectional X-ray scan of a computed tomograph
Note 1 to entry: A CT DOSIMETER contains the following components:
– one or more DETECTOR ASSEMBLIES;
– a MEASURING ASSEMBLY.
3.1.5
CT DETECTOR
RADIATION DETECTOR which is used for CT dosimetry
3.2
INDICATED VALUE
value of a quantity derived from the reading of an instrument together with any scale factors
indicated on the control panel of the instrument
[SOURCE: IEC 60731:2011, 3.2, modified – The note has been deleted.]
3.3
TRUE VALUE
value of the physical quantity to be measured by an instrument
[SOURCE: IEC 60731:2011, 3.3, modified – The note has been deleted.]
3.4
CONVENTIONAL TRUE VALUE
value used instead of the TRUE VALUE when calibrating or determining the performance of an
instrument, since in practice the TRUE VALUE is unknown and unknowable
Note 1 to entry: The CONVENTIONAL TRUE VALUE will usually be the value determined by the WORKING STANDARD with
which the instrument under test is being compared.
[SOURCE: IEC 60731:2011, 3.4, modified – The second note has been deleted.]
– 12 – IEC 61674:2024 CMV © IEC 2024
3.5
MEASURED VALUE
best estimate of the TRUE VALUE of a quantity, being derived from the INDICATED VALUE of an
instrument together with the application of all relevant CORRECTION FACTORS and the
CALIBRATION FACTOR
Note 1 to entry: The MEASURED VALUE is sometimes also referred to as "result of a measurement".
[SOURCE: IEC 60731:2011, 3.5, modified – The existing note has been replaced with a new
note to entry has been added.]
3.5.1
ERROR OF MEASUREMENT
difference remaining between the MEASURED VALUE of a quantity and the TRUE VALUE of that
quantity
[SOURCE: IEC 60731:2011, 3.5.1]
3.5.2
OVERALL UNCERTAINTY
UNCERTAINTY associated with the MEASURED VALUE
Note 1 to entry: I.e. it represents the bounds within which the ERROR OF MEASUREMENT is estimated to lie (see also
4.5).
[SOURCE: IEC 60731:2011, 3.5.2, modified – The parenthesis has been added to the note to
entry, and the second note has been deleted.]
3.5.3
EXPANDED UNCERTAINTY
quantity defining an interval about the result of a measurement that may be expected to
encompass a large fraction of the distribution of values that could reasonably be attributed to
the measurand
[SOURCE: ISO/IEC GUIDE 98-3:2008, 2.3.5, modified – The three notes have been deleted.]
3.6
CORRECTION FACTOR
dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS
[SOURCE: IEC 60731:2011, 3.6]
3.7
INFLUENCE QUANTITY
any external quantity that may affect the performance of an instrument
[SOURCE: IEC 60731:2011, 3.7]
3.8
INSTRUMENT PARAMETER
any internal property of an instrument that may affect the performance of this instrument
[SOURCE: IEC 60731:2011, 3.8]
3.9
REFERENCE VALUE
particular value of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER chosen for the purposes
of reference
Note 1 to entry: i.e., the value of an influence quantity (or INSTRUMENT PARAMETER) at which the CORRECTION FACTOR
for dependence on that INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) is unity.
[SOURCE: IEC 60731:2011, 3.9]
3.9.1
REFERENCE CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
REFERENCE VALUES
[SOURCE: IEC 60731:2011, 3.9.1]
3.10
STANDARD TEST VALUES
value, values, or range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER, which
are permitted when carrying out calibrations or tests on another INFLUENCE QUANTITY or
INSTRUMENT PARAMETER
[SOURCE: IEC 60731:2011, 3.10]
3.10.1
STANDARD TEST CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
STANDARD TEST VALUES
[SOURCE: IEC 60731:2011, 3.10.1]
3.11
PERFORMANCE CHARACTERISTIC
one of the quantities used to define the performance of an instrument
[SOURCE: IEC 60731:2011, 3.11, modified – The note has been deleted.]
3.11.1
RESPONSE
quotient of the INDICATED VALUE
divided by the CONVENTIONAL TRUE VALUE at the position of the REFERENCE POINT of the
IONIZATION CHAMBER RADIATION DETECTOR
[SOURCE: IEC 60731:2011, 3.11.1, modified – Only the first paragraph of the original definition
has been retained.]
3.11.2
RESOLUTION
smallest change of reading to which a numerical value can be assigned without
further interpolation
smallest fraction of a scale interval that can be determined by an observer
under specified conditions
[SOURCE: IEC 60731:2011, 3.11.2, modified – Only the first paragraph has been retained.]
– 14 – IEC 61674:2024 CMV © IEC 2024
3.11.2.1
RESOLUTION
smallest significant increment of the reading
[SOURCE: IEC 60731:2011, 3.11.2, modified – Only the third paragraph has been retained.]
3.11.3
EQUILIBRATION TIME
time taken for a reading to reach and remain within a specified deviation from its final steady
value after a sudden change in an INFLUENCE QUANTITY has been applied to the instrument
[SOURCE: IEC 60731:2011, 3.11.3]
3.11.4
RESPONSE TIME
time taken for a reading to reach and remain within a specified deviation from its final steady
value after a sudden change in the quantity being measured
[SOURCE: IEC 60731:2011, 3.11.4]
3.11.5
STABILIZATION TIME
time taken for a stated PERFORMANCE CHARACTERISTIC to reach and remain within a specified
deviation from its final steady value after the MEASURING ASSEMBLY has been switched on and
the polarizing voltage has been applied to the IONIZATION CHAMBER
[SOURCE: IEC 60731:2011, 3.11.5]
3.11.6
CHAMBER ASSEMBLY LEAKAGE CURRENT
LEAKAGE CURRENT
any current in the signal path arising in the CHAMBER ASSEMBLY which is not produced by
ionization in the measuring volume
[SOURCE: IEC 60731:2011, 3.11.6, modified – The note has been deleted.]
3.12
VARIATION
relative difference, ∆y/y, between the values of a PERFORMANCE CHARACTERISTIC y, when one
INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) assumes successively two specified values,
the other INFLUENCE QUANTITIES (and INSTRUMENT PARAMETERS) being kept constant at the
STANDARD TEST VALUES (unless other values are specified)
[SOURCE: IEC 60731:2011, 3.12]
3.13
LIMITS OF VARIATION
maximum permitted VARIATION of a PERFORMANCE CHARACTERISTIC
Note 1 to entry: If LIMITS OF VARIATION are stated as ±L %, the VARIATION ∆y/y, expressed as a percentage, shall
remain in the range from – L % to + L %.
[SOURCE: IEC 60731:2011, 3.13]
3.14
EFFECTIVE RANGE OF INDICATED VALUES
EFFECTIVE RANGE
range of INDICATED VALUES for which an instrument complies with a stated performance
Note 1 to entry: The maximum (minimum) effective INDICATED VALUE is the highest (lowest) in this range.
Note 2 to entry: The concept of EFFECTIVE RANGE may, for example, also be applied to readings and to related
quantities not directly indicated by the instrument e.g., input current.
[SOURCE: IEC 60731:2011, 3.14]
3.15
RATED RANGE OF USE
RATED RANGE
range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the instrument
will operate within the LIMITS OF VARIATION
Note 1 to entry: Its limits are the maximum and minimum RATED VALUES.
[SOURCE: IEC 60731:2011, 3.15]
3.15.1
MINIMUM RATED RANGE
least range of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER over which the instrument shall
operate within the specified LIMITS OF VARIATION
[SOURCE: IEC 60731:2011, 3.15.1]
3.16
REFERENCE POINT OF A RADIATION DETECTOR
REFERENCE POINT
point of a RADIATION DETECTOR which, during the calibration of the detector, is brought to
coincidence with the point at which the CONVENTIONAL TRUE VALUE is specified
[SOURCE: IEC 60731:2011, 3.16, modified – The term "IONIZATION CHAMBER" has been replaced
with "RADIATION DETECTOR" in both the term and the definition.]
3.17
MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its manufacturer to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
[SOURCE: IEC 60601-1:2005, 3.63, modified – The five notes have not been retained.]
3.18
UNATTENUATED BEAM
X-ray beam incident on the PATIENT or PHANTOM
3.18.1
UNATTENUATED BEAM QUALITY
RADIATION QUALITY of the X-ray beam at the location of the entrance surface of the PATIENT or
the PHANTOM, determined when the latter are absent
3.19
ATTENUATED BEAM
X-ray beam exiting the PATIENT or PHANTOM
– 16 – IEC 61674:2024 CMV © IEC 2024
3.19.1
ATTENUATED BEAM QUALITY
RADIATION QUALITY of the X-ray beam exiting the PATIENT or PHANTOM
3.20
RATED LENGTH
length along the axis of the CT DETECTOR within which the DETECTOR performs to its specification
3.20.1
EFFECTIVE LENGTH
length along the axis of the CT DETECTOR between the two points at which the RESPONSE has
fallen to 50 % of its value at its geometrical centre
3.21
AIR KERMA
K
quotient of dE by dm where dE is the sum of the initial kinetic energies of all the charged
tr tr
ionizing particles liberated by uncharged ionizing particles in air of mass dm
–1
Note 1 to entry: The unit of AIR KERMA is Gy (where 1 Gy = 1 J·kg ).
[SOURCE: IEC 60731:2011, 3.31, modified – The second note has been deleted.]
3.21.1
AIR KERMA RATE
K
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt
–1 –1 –1
Note 1 to entry: The unit of AIR KERMA RATE is Gy·s (Gy·min ; Gy·h ).
[SOURCE: IEC 60731:2011, 3.31.1, modified – The second note has been deleted.]
3.21.2
AIR KERMA LENGTH PRODUCT
P
KL
line integral of the AIR KERMA K over a length L
P = K(z)dz
KL
∫
(1)
L
Note 1 to entry: The unit of AIR KERMA LENGTH PRODUCT is Gy·m (mGy·m).
3.22
X-RAY TUBE VOLTAGE
potential difference applied to an X-RAY TUBE between the ANODE and the CATHODE. Usually, X-
RAY TUBE VOLTAGE is expressed by its peak value in kilovolt (kV) 4
Note 1 to entry: The unit of this quantity is the volt (V).
Note 2 to entry: The X-RAY TUBE VOLTAGE may vary as a function of time. The PRACTICAL PEAK VOLTAGE is a weighted
value of the X-RAY TUBE VOLTAGE over a time period.
[SOURCE: IEC 60601-1-3:2008, 3.88 IEC 61676:2023, 3.25, modified – The information about
the unit has been moved from the definition to a note to entry, and a second note to entry has
been added.]
3.23
COEFFICIENT OF VARIATION
CV
STANDARD DEVIATION divided by the MEAN
[SOURCE: ISO 3534-1:2006, 2.38, modified – The example and the notes have not been
retained.]
3.24
INSTRUCTIONS FOR USE
those parts of the ACCOMPANYING DOCUMENTS giving the necessary information for safe and
proper use and operation of the equipment
[SOURCE: IEC TR 60788:2004, rm-82-02]
4 General requirements
4.1 Performance requirements
In Clause 5 and Clause 6, the performance requirements are stated for a complete DIAGNOSTIC
DOSIMETER including both the DETECTOR ASSEMBLY and MEASURING ASSEMBLY. For a DOSIMETER
designed to operate with one or more DETECTOR ASSEMBLIES, each combination of the
MEASURING ASSEMBLY and DETECTOR ASSEMBLY shall comply with the requirements in 4.4, and in
Clause 5 and Clause 6 relevant to this combination.
4.2 REFERENCE VALUES and STANDARD TEST VALUES
These values are as given in Table 1.
Table 1 – REFERENCE and STANDARD TEST CONDITIONS
INFLUENCE QUANTITY REFERENCE VALUES STANDARD TEST VALUES
Temperature +20 °C +15 °C to +25 °C
Relative humidity 50 % 30 % to 75 %
Air pressure 101,3 kPa Atmospheric pressure
a
As at calibration REFERENCE VALUE ±10 %
AIR KERMA RATE
– 18 – IEC 61674:2024 CMV © IEC 2024
INFLUENCE QUANTITY REFERENCE VALUES STANDARD TEST VALUES
RADIATION QUALITY:
b
Mammography As stated by the manufacturer REFERENCE VALUE
–UNATTENUATED BEAM 28 kV REFERENCE VALUE
all qualities, defined by a special
combination of x-ray tube anode
b
and filtration , as stated by the
manufacturer
–ATTENUATED BEAM 28 Kv REFERENCE VALUE
all qualities, defined by a special
combination of x-ray tube anode
b,
and filtration as stated by the
manufacturer, and an additional
filtration of 2 mm Al
Conventional diagnostic:
– UNATTENUATED BEAM 70 kV (RQR 5 x IEC 61267) REFERENCE VALUE
– ATTENUATED BEAM 70 kV (RQA 5 x IEC 61267) REFERENCE VALUE
c
120 kV (RQT 9 x IEC 61267) REFERENCE VALUE
COMPUTED TOMOGRAPHY :
Copper filtered beam 70 kV (RQC 5 x IEC 61267) REFERENCE VALUE
d
Electromagnetic fields Zero
Insignificant
a
AIR KERMA RATE is only an INFLUENCE QUANTITY for AIR KERMA and AIR KERMA LENGTH PRODUCT measurements.
b
RADIATION QUALITIES used in mammography can shall be based on different stated as combinations of X-RAY
TUBE anode materials (e.g., W,
...
IEC 61674 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
Appareils électromédicaux – Dosimètres à chambres d'ionisation et/ou à
détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
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IEC 61674 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
Appareils électromédicaux – Dosimètres à chambres d'ionisation et/ou à
détecteurs semiconducteurs utilisés en imagerie de diagnostic à rayonnement X
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-8971-6
– 2 – IEC 61674:2024 © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General requirements . 16
4.1 Performance requirements . 16
4.2 REFERENCE VALUES and STANDARD TEST VALUES . 16
4.3 General test conditions . 17
4.3.1 STANDARD TEST CONDITIONS . 17
4.3.2 Statistical fluctuations . 17
4.3.3 STABILIZATION TIME . 17
4.3.4 Adjustments during test . 18
4.3.5 Batteries . 18
4.4 Constructional requirements as related to performance . 18
4.4.1 Components . 18
4.4.2 Display . 18
4.4.3 Indication of battery condition . 18
4.4.4 Indication of polarizing voltage failure . 18
4.4.5 Over-ranging . 19
4.4.6 MEASURING ASSEMBLIES with multiple DETECTOR ASSEMBLIES . 19
4.4.7 Radioactive STABILITY CHECK DEVICE . 20
4.5 UNCERTAINTY of measurement . 20
5 Limits of PERFORMANCE CHARACTERISTICS . 20
5.1 Linearity . 20
5.2 Repeatability . 20
5.2.1 General . 20
5.2.2 Repeatability in the ATTENUATED BEAM . 21
5.2.3 Repeatability in the UNATTENUATED BEAM . 21
5.3 RESOLUTION of reading . 22
5.4 STABILIZATION TIME . 22
5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 22
5.6 Stability. 22
5.6.1 Long term stability . 22
5.6.2 Accumulated dose stability . 23
5.7 Measurements with a radioactive STABILITY CHECK DEVICE . 23
6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 23
6.1 General . 23
6.2 Energy dependence of RESPONSE . 23
6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT
measurements . 25
6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 25
6.4.1 Non-CT detectors . 25
6.4.2 CT DETECTORS . 26
6.5 Operating voltage . 26
6.5.1 Mains-operated DOSIMETERS . 26
6.5.2 Battery-operated DOSIMETERS . 26
6.5.3 Mains rechargeable, battery-operated DOSIMETERS . 26
6.6 Air pressure . 27
6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR . 27
6.8 Temperature and humidity . 27
6.9 Electromagnetic compatibility . 28
6.9.1 ELECTROSTATIC DISCHARGE . 28
6.9.2 Radiated electromagnetic fields . 28
6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies . 29
6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 29
6.10 Field size . 29
6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 29
7 Marking . 30
7.1 DETECTOR ASSEMBLY . 30
7.2 MEASURING ASSEMBLY . 30
7.3 Radioactive STABILITY CHECK DEVICE . 30
8 ACCOMPANYING DOCUMENTS . 30
Annex A (informative) COMBINED STANDARD UNCERTAINTY for dosimeter performance . 32
Bibliography . 33
Index of defined terms . 34
Table 1 – REFERENCE and STANDARD TEST CONDITIONS . 16
Table 2 – Number of readings required to detect true differences ∆ (95 % confidence
level) between two sets of instrument readings . 17
Table 3 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the attenuated beam . 21
Table 4 – Maximum values for the COEFFICIENT OF VARIATION, v , for measurements
max
in the unattenuated beam and mammography . 21
Table 5 – LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 24
Table 6 – Climatic conditions . 27
Table A.1 – Estimation of COMBINED STANDARD UNCERTAINTY for dosimeter performance . 32
– 4 – IEC 61674:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR
DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
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
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9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
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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 61674 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.
This third edition cancels and replaces the second edition published in 2012. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION
QUALITY;
b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION
QUALITIES for the compliance test on energy dependence of response;
c) the compliance test for analogue displays was removed;
d) the compliance tests for range reset, the effect of leakage and recombination losses were
removed. These tests are already covered by the test on linearity and cannot be conducted
for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed
accordingly;
e) the compliance test for mains rechargeable and battery-operated dosimeters were updated
for modern devices.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/909/FDIS 62C/913/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.
In this document, the following print types are used.
– requirements and definitions: roman type.
– test specifications: italic type.
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2:2021. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
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.
– 6 – IEC 61674:2024 © IEC 2024
INTRODUCTION
Diagnostic radiology is the largest contributor to man-made IONIZING RADIATION to which the
public is exposed. The reduction in the exposure received by PATIENTS undergoing medical
radiological examinations or procedures has therefore become a central issue in recent years.
The PATIENT dose will be minimized when the X-ray producing equipment is correctly adjusted
for image quality and radiation output. These adjustments require that the routine measurement
of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE be made accurately. The
equipment covered by this document plays an essential part in achieving the required accuracy.
It is important that the DOSIMETERS used for adjustment and control measurements are of
satisfactory quality and therefore fulfil the special requirements laid down in this document.
MEDICAL ELECTRICAL EQUIPMENT –
DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR
DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
1 Scope and object
1.1 Scope
This document specifies the performance and some related constructional requirements of
DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT
or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as
RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating
potentials in the range of 20 kV to 150 kV.
This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION
CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.
1.2 Object
The object of this document is
a) to establish requirements for a satisfactory level of performance for DIAGNOSTIC DOSIMETERS,
and
b) to standardize the methods for the determination of compliance with this level of
performance.
DOSIMETERS. The DIAGNOSTIC
This document is not concerned with the safety aspects of
DOSIMETERS covered by this document are not intended for use in the PATIENT ENVIRONMENT
and, therefore, the requirements for electrical safety applying to them are contained in
IEC 61010-1.
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 60417, Graphical symbols for use on equipment, available at http://www.graphical-
symbols.info/equipment
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61000-4 (all parts), Electromagnetic compatibility (EMC) – Part 4: Testing and measuring
techniques
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) – Part 4-2: Testing and
measurement techniques – Electrostatic discharge immunity test
IEC 61000-4-3:2020, Electromagnetic compatibility (EMC) – Part 4-3: Testing and
measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement
techniques – Electrical fast transient/burst immunity test
– 8 – IEC 61674:2024 © IEC 2024
IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement
techniques – Immunity to conducted disturbances, induced by radio-frequency fields
IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement
techniques – Voltage dips, short interruptions and voltage variations immunity tests for
equipment with input current up to 16 A per phase
IEC 61187, Electrical and electronic measuring equipment – Documentation
IEC 61267:2005, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC TR 60788:2004 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
DIAGNOSTIC DOSIMETER
DOSIMETER
equipment which uses IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS for the
measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE in the beam of
an X-RAY EQUIPMENT used for diagnostic medical radiological examinations
Note 1 to entry: A DIAGNOSTIC DOSIMETER contains the following components:
– one or more DETECTOR ASSEMBLIES which may or may not be an integral part of the MEASURING ASSEMBLY;
– a MEASURING ASSEMBLY;
– one or more STABILITY CHECK DEVICES (optional).
3.1.1
DETECTOR ASSEMBLY
RADIATION DETECTOR and all other parts to which the RADIATION DETECTOR is permanently
attached, except the MEASURING ASSEMBLY
Note 1 to entry: The DETECTOR ASSEMBLY normally includes:
– the RADIATION DETECTOR and the stem (or body) on which the RADIATION DETECTOR is permanently mounted (or
embedded);
– the electrical fitting and any permanently attached cable or pre-amplifier.
3.1.1.1
RADIATION DETECTOR
element which transduces AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE into a
measurable electrical signal
Note 1 to entry: A radiation detector may be either an ionization chamber or a semiconductor detector.
3.1.1.1.1
IONIZATION CHAMBER
CHAMBER
RADIATION DETECTOR filled with air, a suitable gas, or a gaseous mixture, in which an electric
field is provided for the total collection, at the electrodes, of charges associated with the ions
and the electrons produced in the sensitive volume of the detector by the ionizing radiation
Note 1 to entry: An ionization chamber can be sealed or vented.
Note 2 to entry: Vented ionization chambers are constructed in such a way as to allow the air inside the measuring
volume to communicate freely with the atmosphere, so that corrections to the response for changes in air density
need to be made.
Note 3 to entry: Sealed ionization chambers are not suitable, because the necessary wall thickness of a sealed
chamber may cause an unacceptable energy dependence of the response and because the long-term stability of
sealed chambers is not guaranteed.
[SOURCE: IEC 60050-395:2014, 395-03-07, modified – Two new notes to entry were added.]
3.1.1.1.2
VENTED IONIZATION CHAMBER
IONIZATION CHAMBER constructed in such a way as to allow the air inside the measuring volume
to communicate freely with the atmosphere such that corrections to the RESPONSE for changes
in air density need to be made
[SOURCE: IEC 60731:2011, 3.1.1.1.3, modified – The term has been changed from "vented
chamber" to "VENTED IONIZATION CHAMBER".]
3.1.1.1.3
SEMICONDUCTOR DETECTOR
semiconductor device that utilises the production and motion of electron-hole pairs in a charge
carrier depleted region of the semiconductor for the detection and measurement of IONIZING
RADIATION
Note 1 to entry: The production of electron-hole pairs is caused by interaction of the IONIZING RADIATION with the
semiconductor material. In the purview of this document, detectors qualify as semiconductor detectors, even when
the production of electron-hole pairs is caused indirectly by first converting the incident radiation energy to light in a
scintillator material directly in front of and optically coupled to a semiconductor photodiode, which then produces the
electrical signal.
3.1.2
MEASURING ASSEMBLY
device to measure the electrical signal from the RADIATION DETECTOR and convert it into a form
suitable for displaying the values of DOSE or KERMA or their corresponding rates
[SOURCE: IEC 60731:2011, 3.1.2, modified – The words "measure the charge (or current) from
the IONIZATION CHAMBER" have been replaced with "measure the electrical signal from the
RADIATION DETECTOR".]
3.1.3
STABILITY CHECK DEVICE
device which enables the stability of RESPONSE of the MEASURING ASSEMBLY and/or CHAMBER
ASSEMBLY to be checked
Note 1 to entry: The STABILITY CHECK DEVICE may be a purely electrical device, or a radiation source, or it may
include both.
[SOURCE: IEC 60731:2011, 3.1.3]
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3.1.4
CT DOSIMETER
DIAGNOSTIC DOSIMETER which uses long narrow IONIZATION CHAMBERS and/or SEMICONDUCTOR
DETECTORS for the measurement of AIR KERMA integrated along the length of the DETECTOR when
the DETECTOR is exposed to a cross-sectional X-ray scan of a computed tomograph
Note 1 to entry: A CT DOSIMETER contains the following components:
– one or more DETECTOR ASSEMBLIES;
– a MEASURING ASSEMBLY.
3.1.5
CT DETECTOR
RADIATION DETECTOR which is used for CT dosimetry
3.2
INDICATED VALUE
value of a quantity derived from the reading of an instrument together with any scale factors
indicated on the control panel of the instrument
[SOURCE: IEC 60731:2011, 3.2, modified – The note has been deleted.]
3.3
TRUE VALUE
value of the physical quantity to be measured by an instrument
[SOURCE: IEC 60731:2011, 3.3, modified – The note has been deleted.]
3.4
CONVENTIONAL TRUE VALUE
value used instead of the TRUE VALUE when calibrating or determining the performance of an
instrument, since in practice the TRUE VALUE is unknown and unknowable
Note 1 to entry: The CONVENTIONAL TRUE VALUE will usually be the value determined by the WORKING STANDARD with
which the instrument under test is being compared.
[SOURCE: IEC 60731:2011, 3.4, modified – The second note has been deleted.]
3.5
MEASURED VALUE
best estimate of the TRUE VALUE of a quantity, being derived from the INDICATED VALUE of an
CORRECTION FACTORS and the
instrument together with the application of all relevant
CALIBRATION FACTOR
Note 1 to entry: The MEASURED VALUE is sometimes also referred to as "result of a measurement".
[SOURCE: IEC 60731:2011, 3.5, modified – The existing note has been replaced with a new
note to entry.]
3.5.1
ERROR OF MEASUREMENT
difference remaining between the MEASURED VALUE of a quantity and the TRUE VALUE of that
quantity
[SOURCE: IEC 60731:2011, 3.5.1]
3.5.2
OVERALL UNCERTAINTY
UNCERTAINTY associated with the MEASURED VALUE
Note 1 to entry: I.e. it represents the bounds within which the ERROR OF MEASUREMENT is estimated to lie (see also
4.5).
[SOURCE: IEC 60731:2011, 3.5.2, modified – The parenthesis has been added to the note to
entry, and the second note has been deleted.]
3.5.3
EXPANDED UNCERTAINTY
quantity defining an interval about the result of a measurement that may be expected to
encompass a large fraction of the distribution of values that could reasonably be attributed to
the measurand
[SOURCE: ISO/IEC GUIDE 98-3:2008, 2.3.5, modified – The three notes have been deleted.]
3.6
CORRECTION FACTOR
dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value
when operated under particular conditions to its value when operated under stated REFERENCE
CONDITIONS
[SOURCE: IEC 60731:2011, 3.6]
3.7
INFLUENCE QUANTITY
external quantity that may affect the performance of an instrument
[SOURCE: IEC 60731:2011, 3.7]
3.8
INSTRUMENT PARAMETER
internal property of an instrument that may affect the performance of this instrument
[SOURCE: IEC 60731:2011, 3.8]
3.9
REFERENCE VALUE
particular value of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER chosen for the purposes
of reference
Note 1 to entry: i.e., the value of an influence quantity (or INSTRUMENT PARAMETER) at which the CORRECTION FACTOR
for dependence on that INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) is unity.
[SOURCE: IEC 60731:2011, 3.9]
3.9.1
REFERENCE CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
REFERENCE VALUES
[SOURCE: IEC 60731:2011, 3.9.1]
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3.10
STANDARD TEST VALUES
value, values, or range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER, which
are permitted when carrying out calibrations or tests on another INFLUENCE QUANTITY or
INSTRUMENT PARAMETER
[SOURCE: IEC 60731:2011, 3.10]
3.10.1
STANDARD TEST CONDITIONS
conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
STANDARD TEST VALUES
[SOURCE: IEC 60731:2011, 3.10.1]
3.11
PERFORMANCE CHARACTERISTIC
one of the quantities used to define the performance of an instrument
[SOURCE: IEC 60731:2011, 3.11, modified – The note has been deleted.]
3.11.1
RESPONSE
quotient of the INDICATED VALUE divided by the
CONVENTIONAL TRUE VALUE at the position of the REFERENCE POINT of the RADIATION DETECTOR
[SOURCE: IEC 60731:2011, 3.11.1, modified – Only the first paragraph has been retained.]
3.11.2
RESOLUTION
smallest change of reading to which a numerical value can be assigned without
further interpolation
[SOURCE: IEC 60731:2011, 3.11.2, modified – Only the first paragraph has been retained.]
3.11.2.1
RESOLUTION
smallest significant increment of the reading
[SOURCE: IEC 60731:2011, 3.11.2, modified – Only the third paragraph has been retained.]
3.11.3
EQUILIBRATION TIME
time taken for a reading to reach and remain within a specified deviation from its final steady
value after a sudden change in an INFLUENCE QUANTITY has been applied to the instrument
[SOURCE: IEC 60731:2011, 3.11.3]
3.11.4
RESPONSE TIME
time taken for a reading to reach and remain within a specified deviation from its final steady
value after a sudden change in the quantity being measured
[SOURCE: IEC 60731:2011, 3.11.4]
3.11.5
STABILIZATION TIME
time taken for a stated PERFORMANCE CHARACTERISTIC to reach and remain within a specified
deviation from its final steady value after the MEASURING ASSEMBLY has been switched on and
the polarizing voltage has been applied to the IONIZATION CHAMBER
[SOURCE: IEC 60731:2011, 3.11.5]
3.11.6
CHAMBER ASSEMBLY LEAKAGE CURRENT
LEAKAGE CURRENT
current in the signal path arising in the CHAMBER ASSEMBLY which is not produced by ionization
in the measuring volume
[SOURCE: IEC 60731:2011, 3.11.6, modified – The note has been deleted.]
3.12
VARIATION
relative difference, ∆y/y, between the values of a PERFORMANCE CHARACTERISTIC y, when one
INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) assumes successively two specified values,
the other INFLUENCE QUANTITIES (and INSTRUMENT PARAMETERS) being kept constant at the
STANDARD TEST VALUES (unless other values are specified)
[SOURCE: IEC 60731:2011, 3.12]
3.13
LIMITS OF VARIATION
maximum permitted VARIATION of a PERFORMANCE CHARACTERISTIC
Note 1 to entry: If LIMITS OF VARIATION are stated as ±L %, the VARIATION ∆y/y, expressed as a percentage, shall
remain in the range from – L % to + L %.
[SOURCE: IEC 60731:2011, 3.13]
3.14
EFFECTIVE RANGE OF INDICATED VALUES
EFFECTIVE RANGE
range of INDICATED VALUES for which an instrument complies with a stated performance
Note 1 to entry: The maximum (minimum) effective INDICATED VALUE is the highest (lowest) in this range.
Note 2 to entry: The concept of EFFECTIVE RANGE may, for example, also be applied to readings and to related
quantities not directly indicated by the instrument e.g., input current.
[SOURCE: IEC 60731:2011, 3.14]
3.15
RATED RANGE OF USE
RATED RANGE
range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the instrument
will operate within the LIMITS OF VARIATION
Note 1 to entry: Its limits are the maximum and minimum RATED VALUES.
[SOURCE: IEC 60731:2011, 3.15]
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3.15.1
MINIMUM RATED RANGE
least range of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER over which the instrument shall
operate within the specified LIMITS OF VARIATION
[SOURCE: IEC 60731:2011, 3.15.1]
3.16
REFERENCE POINT OF A RADIATION DETECTOR
REFERENCE POINT
point of a RADIATION DETECTOR which, during the calibration of the detector, is brought to
coincidence with the point at which the CONVENTIONAL TRUE VALUE is specified
[SOURCE: IEC 60731:2011, 3.16, modified – The term "IONIZATION CHAMBER" has been replaced
RADIATION DETECTOR" in both the term and the definition.]
with "
3.17
MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its manufacturer to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
[SOURCE: IEC 60601-1:2005, 3.63, modified – The five notes have not been retained.]
3.18
UNATTENUATED BEAM
X-ray beam incident on the PATIENT or PHANTOM
3.18.1
UNATTENUATED BEAM QUALITY
RADIATION QUALITY of the X-ray beam at the location of the entrance surface of the PATIENT or
the PHANTOM, determined when the latter are absent
3.19
ATTENUATED BEAM
X-ray beam exiting the PATIENT or PHANTOM
3.19.1
ATTENUATED BEAM QUALITY
RADIATION QUALITY of the X-ray beam exiting the PATIENT or PHANTOM
3.20
RATED LENGTH
length along the axis of the CT DETECTOR within which the DETECTOR performs to its specification
3.20.1
EFFECTIVE LENGTH
length along the axis of the CT DETECTOR between the two points at which the RESPONSE has
fallen to 50 % of its value at its geometrical centre
3.21
AIR KERMA
K
quotient of dE by dm where dE is the sum of the initial kinetic energies of all the charged
tr tr
ionizing particles liberated by uncharged ionizing particles in air of mass dm
–1
Note 1 to entry: The unit of AIR KERMA is Gy (where 1 Gy = 1 J·kg ).
[SOURCE: IEC 60731:2011, 3.31, modified – The second note has been deleted.]
3.21.1
AIR KERMA RATE
K
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt
–1 –1 –1
Note 1 to entry: The unit of AIR KERMA RATE is Gy·s (Gy·min ; Gy·h ).
[SOURCE: IEC 60731:2011, 3.31.1, modified – The second note has been deleted.]
3.21.2
AIR KERMA LENGTH PRODUCT
P
KL
line integral of the AIR KERMA K over a length L
P = K(z)dz
KL
∫
(1)
L
Note 1 to entry: The unit of AIR KERMA LENGTH PRODUCT is Gy·m (mGy·m).
3.22
X-RAY TUBE VOLTAGE
potential difference applied to an X-RAY TUBE between the ANODE and the CATHODE
Note 1 to entry: The unit of this quantity is the volt (V).
Note 2 to entry: The X-RAY TUBE VOLTAGE may vary as a function of time. The PRACTICAL PEAK VOLTAGE is a weighted
value of the X-RAY TUBE VOLTAGE over a time period.
[SOURCE: IEC 61676:2023, 3.25, modified – The information about the unit has been moved
from the definition to a note to entry, and a second note to entry has been added.]
3.23
COEFFICIENT OF VARIATION
CV
STANDARD DEVIATION divided by the MEAN
[SOURCE: ISO 3534-1:2006, 2.38, modified – The example and the notes have not been
retained.]
3.24
INSTRUCTIONS FOR USE
those parts of the ACCOMPANYING DOCUMENTS giving the necessary information for safe and
proper use and operation of the equipment
[SOURCE: IEC TR 60788:2004, rm-82-02]
– 16 – IEC 61674:2024 © IEC 2024
4 General requirements
4.1 Performance requirements
In Clause 5 and Clause 6, the performance requirements are stated for a complete DIAGNOSTIC
DOSIMETER including both the DETECTOR ASSEMBLY and MEASURING ASSEMBLY. For a DOSIMETER
designed to operate with one or more DETECTOR ASSEMBLIES, each combination of the
MEASURING ASSEMBLY and DETECTOR ASSEMBLY shall comply with the requirements in 4.4, and in
Clause 5 and Clause 6 relevant to this combination.
4.2 REFERENCE VALUES and STANDARD TEST VALUES
These values are as given in Table 1.
Table 1 – REFERENCE and STANDARD TEST CONDITIONS
INFLUENCE QUANTITY REFERENCE VALUES STANDARD TEST VALUES
Temperature +20 °C +15 °C to +25 °C
Relative humidity 50 % 30 % to 75 %
Air pressure 101,3 kPa Atmospheric pressure
a
As at calibration REFERENCE VALUE ±10 %
AIR KERMA RATE
RADIATION QUALITY:
b
Mammography REFERENCE VALUE
As stated by the manufacturer
Conventional diagnostic:
– UNATTENUATED BEAM 70 kV (RQR 5 x IEC 61267) REFERENCE VALUE
– ATTENUATED BEAM 70 kV (RQA 5 x IEC 61267) REFERENCE VALUE
c
120 kV (RQT 9 x IEC 61267) REFERENCE VALUE
COMPUTED TOMOGRAPHY :
Copper filtered beam 70 kV (RQC 5 x IEC 61267) REFERENCE VALUE
d
Electromagnetic fields Zero
Insignificant
a
AIR KERMA RATE is only an INFLUENCE QUANTITY for AIR KERMA and AIR KERMA LENGTH PRODUCT measurements.
b
RADIATION QUALITIES used in mammography shall be stated as combinations of X-RAY TUBE anode materials
(e.g., W, Mo, Rh) and filtrations (e.g., Al, Mo, Rh, Pd, Ag). Each such combination may have its own RATED
RANGE. If applicable, established radiation qualities should be used as defined in IEC 61267.
c
The RADIATION DETECTOR shall be irradiated by a radiation field with a diameter not smaller than twice the
diameter of the RADIATION DETECTOR. The RADIATION DETECTOR shall be exposed with the beam aligned across
the centre of the active length of the RADIATION DETECTOR.
d
"Insignificant" means that the field is sufficiently small not to have any determinable effect on the RESPONSE of
the DOSIMETER, for example as exists in a normal laboratory environment without special shielding.
4.3 General test conditions
4.3.1 STANDARD TEST CONDITIONS
The STANDARD
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