EN IEC 61676:2023
(Main)Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der Röntgenröhrenspannung in der diagnostischen Radiologie
Appareils électromédicaux - Appareils de dosimétrie pour le mesurage non invasif de la tension du tube radiogène dans la radiologie de diagnostic
IEC 61676:2023 est disponible sous forme de IEC 61676:2023 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61676:2023 spécifie les exigences de performance des appareils utilisés dans le mesurage non invasif de la tension du tube radiogène jusqu’à 150 kV et les essais de conformité applicables. Le présent document décrit également la méthode d’étalonnage et donne des recommandations pour l’estimation de l’incertitude des mesurages réalisés dans des conditions différentes de celles rencontrées au cours de l’étalonnage. Les applications pour un tel mesurage se rencontrent dans la radiologie de diagnostic y compris la mammographie, la tomodensitométrie, la radiologie dentaire et la radioscopie. Le présent document ne traite pas des aspects sécurité de tels appareils. Les exigences pour la sécurité électrique s’appliquant à ceux-ci figurent dans l’IEC 61010-1. L'IEC 61676:2023 annule et remplace la première édition parue en 2002 et l'Amendement 1:2008. Cette édition constitue une révision technique. Elle comprend une évaluation de l’incertitude type composée pour les performances d’un appareil hypothétique pour le mesurage non invasif de la haute tension du tube (à l’Annexe A) qui remplace l’Annexe A de l’édition 1.1 intitulée "Critères de performances recommandés pour le diviseur invasif".
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje napetosti rentgenske elektronke v diagnostični radiologiji (IEC 61676:2023)
Ta dokument določa zahteve glede zmogljivosti opreme, ki se uporablja pri POSREDNEM MERJENJU NAPETOSTI RENTGENSKE ELEKTRONKE do 150 kV, in ustrezne preskuse skladnosti.
Opisuje tudi metodo za UMERJANJE in podaja smernice za ocenjevanje negotovosti pri merjenju, opravljenem pod pogoji, ki niso enaki tistim med UMERJANJEM.
Tovrstno merjenje se uporablja v diagnostični RADIOLOGIJI, vključno z mamografijo, RAČUNALNIŠKI PODPRTI TOMOGRAFIJI (CT), radiologiji v dentalni medicini in RADIOSKOPIJI. Varnostni vidik takšne opreme ni obravnavan v tem dokumentu. Zahteve za predpisano električno varnost opreme so navedene v standardu IEC 61010-1.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2023
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje
napetosti rentgenske elektronke v diagnostični radiologiji (IEC 61676:2023)
Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2023)
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der
Röntgenröhrenspannung in der diagnostischen Radiologie (IEC 61676:2023)
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la
tension du tube radiogène dans la radiologie de diagnostic (IEC 61676:2023)
Ta slovenski standard je istoveten z: EN IEC 61676:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61676
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2023
ICS 11.040.50; 11.040.55 Supersedes EN 61676:2002; EN 61676:2002/A1:2009
English Version
Medical electrical equipment - Dosimetric instruments used for
non-invasive measurement of X-ray tube voltage in diagnostic
radiology
(IEC 61676:2023)
Appareils électromédicaux - Appareils de dosimétrie pour le Medizinische elektrische Geräte - Geräte für die nicht-
mesurage non invasif de la tension du tube radiogène dans invasive Messung der Röntgenröhrenspannung in der
la radiologie de diagnostic diagnostischen Radiologie
(IEC 61676:2023) (IEC 61676:2023)
This European Standard was approved by CENELEC on 2023-04-25. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61676:2023 E
European foreword
The text of document 62C/830/CDV, future edition 2 of IEC 61676, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-01-25
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-04-25
document have to be withdrawn
This document supersedes EN 61676:2002 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61676:2023 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60580:2019 NOTE Approved as EN IEC 60580:2020 (not modified)
IEC 60731:2011 NOTE Approved as EN 60731:2012 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60417 - Graphical symbols for use on equipment. - -
Index, survey and compilation of the single
sheets.
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61000-4-2 - Electromagnetic compatibility (EMC) - EN 61000-4-2 -
Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity
test
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - EN IEC 61000-4-3 -
Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61000-4-4 - Electromagnetic compatibility (EMC) - EN 61000-4-4 -
Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst
immunity test
IEC 61000-4-5 - Electromagnetic compatibility (EMC) - EN 61000-4-5 -
Part 4-5: Testing and measurement
techniques - Surge immunity test
IEC 61000-4-6 - Electromagnetic compatibility (EMC) - EN 61000-4-6 -
Part 4-6: Testing and measurement
techniques - Immunity to conducted
disturbances, induced by radio-frequency
fields
Publication Year Title EN/HD Year
IEC 61000-4-11 - Electromagnetic compatibility (EMC) - EN IEC 61000-4-11 -
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 61010-1 - Safety requirements for electrical equipment - -
for measurement, control and laboratory use -
- Part 1: General requirements
IEC 61187 - Electrical and electronic measuring EN 61187 -
equipment - Documentation
ISO 7000 2019 Graphical symbols for use on equipment_- - -
Registered symbols
IEC 61676 ®
Edition 2.0 2023-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
Appareils électromédicaux – Appareils de dosimétrie pour le mesurage non
invasif de la tension du tube radiogène dans la radiologie de diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50; 11.040.55 ISBN 978-2-8322-6698-4
– 2 – IEC 61676:2023 © IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE
measurements . 11
4.1 Quantity to be measured . 11
4.2 Limits of PERFORMANCE CHARACTERISTICS . 11
4.2.1 Limits . 11
4.2.2 Maximum error . 11
4.2.3 Over and under range indications . 12
4.2.4 Repeatability . 13
4.2.5 Long term stability . 13
4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 13
4.3.1 INFLUENCE QUANTITIES . 13
4.3.2 MINIMUM RATED RANGE of use . 13
4.3.3 REFERENCE CONDITIONS . 14
4.3.4 STANDARD TEST CONDITIONS . 14
4.3.5 LIMITS OF VARIATION . 14
4.4 Performance test procedures . 15
4.4.1 General remarks . 15
4.4.2 Dependence of instrument RESPONSE on voltage waveform and
frequency . 16
4.4.3 Dependence of instrument RESPONSE on ANODE ANGLE . 17
4.4.4 Dependence of instrument RESPONSE on FILTRATION . 17
4.4.5 Dependence of instrument RESPONSE on dose rate . 17
4.4.6 Dependence of instrument RESPONSE on IRRADIATION TIME . 18
4.4.7 Dependence of instrument RESPONSE on field size . 18
4.4.8 Dependence of instrument RESPONSE on focus-to-detector distance . 18
4.4.9 Dependence of instrument RESPONSE on angle of incidence of RADIATION . 19
4.4.10 Dependence of instrument RESPONSE on angle of detector rotation with
respect to the X-RAY TUBE axis . 19
4.4.11 Dependence of instrument RESPONSE on temperature and humidity . 19
4.4.12 Dependence of instrument RESPONSE on operating voltage . 20
4.4.13 Dependence of instrument RESPONSE on electromagnetic compatibility . 21
4.4.14 Additional tungsten filtration (tube aging) . 22
5 Special instrumental requirements and marking . 23
5.1 Requirements for the complete instruments . 23
5.2 General . 23
5.3 Display . 23
5.4 Range of measurement . 23
5.5 Connectors and cables . 23
6 ACCOMPANYING DOCUMENTS . 24
6.1 General . 24
6.2 Information provided . 24
6.3 Instrument description . 24
IEC 61676:2023 © IEC 2023 – 3 –
6.4 Detector . 24
6.5 Delay time . 24
6.6 Measurement window . 24
6.7 Data outlet . 24
6.8 Transport and storage . 24
Annex A (informative) COMBINED STANDARD UNCERTAINTY . 25
Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE . 26
B.1 Overview. 26
B.2 Simplified formalism for the determination of the PRACTICAL PEAK VOLTAGE Û . 26
Bibliography . 32
Index of defined terms . 33
Figure B.1 – Example of a waveform of a two-pulse generator . 28
Figure B.2 – Example of a waveform of a constant-voltage generator . 28
Figure B.3 – Example of falling load waveform . 29
Table 1 – Minimum effective ranges . 11
Table 2 – Minimum RATED RANGE OF USE, REFERENCE CONDITIONS, STANDARD TEST
CONDITIONS, LIMITS OF VARIATION (± L) and INTRINSIC ERROR (E) over the EFFECTIVE
RANGE of use, for the pertaining INFLUENCE QUANTITY . 14
Table 3 – Minimum test points and test values of PRACTICAL PEAK VOLTAGE for
INFLUENCE QUANTITIES . 16
Table 4 – Maximum HALF-VALUE LAYER (HVL) depending on anode angle . 23
Table A.1 – Example for assessment of the COMBINED STANDARD UNCERTAINTY –
Instruments used for NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE . 25
Table B.1 – Values of 20 samples of the falling load waveform in Figure B.3 . 29
Table B.2 – Voltage bins, probability and weighting factors for the 20 samples
of the falling load waveform in Figure B.3 . 30
Table B.3 – Weighting factors for the 20 equally spaced samples of the falling load
waveform in Figure B.3 . 31
– 4 – IEC 61676:2023 © IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT – DOSIMETRIC INSTRUMENTS
USED FOR NON-INVASIVE MEASUREMENT OF X-RAY TUBE VOLTAGE
IN DIAGNOSTIC RADIOLOGY
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,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
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
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 61676 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 second edition of IEC 61676 cancels and replaces first edition published in 2002,
Amendment 1:2008. This edition constitutes a technical revision.
It includes an assessment of the COMBINED STANDARD UNCERTAINTY for the performance of a
hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A)
which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the
invasive divider".
IEC 61676:2023 © IEC 2023 – 5 –
The text of this document is based on the following documents:
Draft Report on voting
62C/830/CDV 62C/866/RVC
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/standardsdev/publications.
In this document the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, general statements and exceptions: in small roman type;
– test specifications: in italic type;
– TERMS USED THROUGHOUT THIS DOCUMENT THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN
IEC 60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.
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,
• replaced by a revised edition, or
• amended.
NOTE The committee knows this second edition of the document does still not address all problems associated
with non-invasive high voltage measurements. For mammography only molybdenum filtration is considered in
conjunction with a molybdenum anode although in addition tungsten and rhodium anodes with other filtrations are in
use like rhodium, aluminium, copper, silver or titanium. At the time when this document was drafted there were not
enough data available in the literature to define realistic limits of variation for these types of INFLUENCE QUANTITIES.
On the other hand, the committee was informed that several international projects were started to examine the
general behaviour of non-invasive X-ray multimeters of the main MANUFACTURERS. Results from these studies were
to be expected within about 5 years. Therefore, the committee decided to set a short stability time for the second
edition and update the document as soon as the results from these new examinations will be available.
– 6 – IEC 61676:2023 © IEC 2023
INTRODUCTION
The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive
instruments is normally expressed in the form of one single number for the value of the tube
voltage, irrespective of whether the tube voltage is constant potential or shows a time
dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE
VOLTAGE on the market usually indicate the "MEAN PEAK VOLTAGE". But the quantity "MEAN PEAK
VOLTAGE" is not unambiguously defined and can be any mean of all voltage peaks. It is
impossible to establish test procedures for the performance requirements of non-invasive
instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the
quantity under consideration. Therefore, this document is based on a quantity called "PRACTICAL
PEAK VOLTAGE". The PRACTICAL PEAK VOLTAGE is unambiguously defined and applicable to any
waveform. This quantity is related to the spectral distribution of the emitted X-RADIATION and
the image properties. X-RAY GENERATORS operating at the same value of the PRACTICAL PEAK
VOLTAGE produce the same low-level contrast in the RADIOGRAMS, even when the waveforms of
the tube voltages are different. Detailed information on this concept is provided in Annex B. An
example for the calculation of the PRACTICAL PEAK VOLTAGE in the case of a "falling load"
waveform is also given in Annex B.
The CALIBRATION and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generally
performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments utilising
NON-INVASIVE MEASUREMENTS can also be used to check the CALIBRATION or to adjust the X-RAY
TUBE VOLTAGE. These instruments are used to have uncertainties of the voltage measurement
comparable with the INVASIVE MEASUREMENT. One of the most important parameters of
diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because both the image
quality in diagnostic radiology and the DOSE received by the PATIENT undergoing radiological
examinations are dependent on the X-RAY TUBE VOLTAGE. An overall uncertainty below ±5 % is
applicable, and this value serves as a guide for the LIMITS OF VARIATION for the effects of
INFLUENCE QUANTITIES.
IEC 61676:2023 © IEC 2023 – 7 –
MEDICAL ELECTRICAL EQUIPMENT – DOSIMETRIC INSTRUMENTS
USED FOR NON-INVASIVE MEASUREMENT OF X-RAY TUBE VOLTAGE
IN DIAGNOSTIC RADIOLOGY
1 Scope
This document specifies the performance requirements of instruments as used in the NON-
INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE up to 150 kV and the relevant compliance tests.
CALIBRATION and gives guidance for estimating
This document also describes the method for
the uncertainty in measurements performed under conditions different from those during
CALIBRATION.
Applications for such measurement are found in diagnostic RADIOLOGY including mammography,
COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY. This document is not
concerned with the safety aspect of such instruments. 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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
techniques – Electrostatic discharge immunity test
IEC 61000-4-3, 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 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement
techniques – Surge 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
– 8 – IEC 61676:2023 © IEC 2023
IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and
laboratory use – Part 1: General requirements
IEC 61187, Electrical and electronic measuring equipment – Documentation
ISO 7000:2019, Graphical symbols for use on equipment – Registered symbol
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC TR 60788:2004 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE 1 An Index of defined terms is to be found at the end of the document.
NOTE 2 A searchable IEC Glossary can be found at std.iec.ch.
3.1
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
3.2
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.
3.3
INDICATED VALUE
value of quantity derived from the scale reading of an instrument together with any scale factors
indicated on the control panel of the instrument
3.4
INFLUENCE QUANTITY
any external quantity that can affect the performance of an instrument (e.g., ambient
temperature etc.) and any property of the X-RAY EQUIPMENT under test that shall be taken into
account in using the instrument for NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE (e.g.,
range of X-RAY TUBE VOLTAGE, ANODE ANGLE, anode material, TOTAL FILTRATION, etc.)
3.5
INSTRUMENT PARAMETER
any internal property of an instrument that can affect the performance of the instrument
3.6
INTRINSIC ERROR
deviation of the MEASURED VALUE (i.e., the INDICATED VALUE, corrected to REFERENCE CONDITIONS)
from the CONVENTIONAL TRUE VALUE under STANDARD TEST CONDITIONS
IEC 61676:2023 © IEC 2023 – 9 –
3.7
INVASIVE MEASUREMENT
measurement of the X-RAY TUBE VOLTAGE by external connection of a suitable meter or a high
resistance divider
3.8
LIMITS OF VARIATION
maximum VARIATION of a PERFORMANCE CHARACTERISTIC y, permitted by this document
Note 1 to entry: If the LIMITS OF VARIATION are stated as ±L % the VARIATION Δy / y, expressed as a percentage, shall
remain in the range from −L % to +L %.
3.9
MAXIMUM PEAK VOLTAGE
maximum value of the X-RAY TUBE VOLTAGE in a specified time interval
Note 1 to entry: The unit of this quantity is the volt (V).
3.10
MEAN PEAK VOLTAGE
mean value of all X-RAY TUBE VOLTAGE peaks during a specified time interval
Note 1 to entry: The unit of this quantity is the volt (V).
3.11
MEASURED VALUE
best estimate of the CONVENTIONAL TRUE VALUE of a quantity, being derived from the INDICATED
VALUE of an instrument together with the application of all relevant CORRECTION FACTORS
Note 1 to entry: The CONVENTIONAL TRUE VALUE is usually the value determined by the working standard with which
the instrument under test is being compared.
3.12
MINIMUM EFFECTIVE RANGE
smallest permitted range of INDICATED VALUES for which an instrument complies with a stated
performance
3.13
NON-INVASIVE MEASUREMENT
measurement of X-RAY TUBE VOLTAGE by analysis of the emitted RADIATION
3.14
PERFORMANCE CHARACTERISTIC
one of the quantities used to define the performance of an instrument (e.g., RESPONSE)
3.15
VOLTAGE RIPPLE
VOLTAGE at the X-RAY TUBE, r, expressed as a percentage of the peak voltage, U , over a
max
specified time interval
Note 1 to entry: The VOLTAGE RIPPLE is expressed by the formula:
U −U
max min
r ×100 %
U
max
where U is the highest voltage in the interval, and U is the lowest voltage in the interval.
max min
=
– 10 – IEC 61676:2023 © IEC 2023
3.16
PRACTICAL PEAK VOLTAGE
PPV
U
max
p()U × w()U ×UdU
∫
U U
max
min
with p()U dU= 1
∫
U
U
max
min
p()U × w()U × dU
∫
U
min
where p(U) is the distribution function for the voltage U and w(U) is a weighting function, U
max
is the highest voltage in the interval, and U is the lowest voltage in the interval
min
Note 1 to entry: The unit of the quantity PRACTICAL PEAK VOLTAGE is the volt (V).
Note 2 to entry: Additional information on the PRACTICAL PEAK VOLTAGE, the weighting function w(U) and the
distribution function p(U) is provided in Annex B. Using this weighting function w(U) the PRACTICAL PEAK VOLTAGE is
defined as the constant potential which produces the same AIR KERMA contrast behind a specified PHANTOM as the
non-DC voltage under test.
3.17
RATED RANGE
RATED RANGE OF USE
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: The limits of rated range are the maximum and minimum RATED values.
Note 2 to entry: The MINIMUM RATED RANGE is the least range of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER
within which the instrument shall operate within the specified LIMITS OF VARIATION in order to comply with this
document.
3.18
REFERENCE CONDITION
condition under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
REFERENCE VALUES
3.19
REFERENCE VALUE
particular value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) chosen for the purposes
of reference 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
3.20
RELATIVE INTRINSIC ERROR
ratio of the INTRINSIC ERROR to the CONVENTIONAL TRUE VALUE
3.21
RESPONSE
quotient of the INDICATED VALUE divided by the CONVENTIONAL TRUE VALUE
3.22
STANDARD TEST CONDITION
condition under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
STANDARD TEST VALUES
3.23
STANDARD TEST VALUE
value or a range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER, which is
permitted when carrying out CALIBRATIONS or tests on another INFLUENCE QUANTITY or
INSTRUMENT PARAMETER
IEC 61676:2023 © IEC 2023 – 11 –
3.24
VARIATION
relative difference Δy / 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
3.25
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).
4 General performance requirements for measurement of PRACTICAL PEAK
VOLTAGE measurements
4.1 Quantity to be measured
PRACTICAL PEAK VOLTAGE.
The quantity to be measured is the
NOTE Additional quantities can be displayed.
The MINIMUM EFFECTIVE RANGES of PRACTICAL PEAK VOLTAGE shall be as listed in Table 1 for the
relevant X-RAY applications.
Table 1 – Minimum effective ranges
Application Nominal anode material MINIMUM EFFECTIVE RANGE
Mammography
a)
Mo 24 kV to 35 kV
20 kV to 50 kV
Diagnostic
W 60 kV to 120 kV
40 kV to 150 kV
CT
W 80 kV to 140 kV
70 kV to 150 kV
Dental
W 60 kV to 90 kV
40 kV to 110 kV
Fluoroscopic
W 60 kV to 120 kV
40 kV to 130 kV
a)
For mammography anode materials other than Mo, the MINIMUM EFFECTIVE RANGE
of PPV shall be at least 10 kV.
4.2 Limits of PERFORMANCE CHARACTERISTICS
4.2.1 Limits
All values of the limits of PERFORMANCE CHARACTERISTICS stated in this subclause do not contain
the uncertainty of the test equipment.
4.2.2 Maximum error
4.2.2.1 Maximum RELATIVE INTRINSIC ERROR for voltages above 50 kV
RELATIVE INTRINSIC ERROR, l, of PRACTICAL PEAK VOLTAGE, Û, measurements made under
The
STANDARD TEST CONDITIONS, shall not be greater than ±2 % over the EFFECTIVE RANGE of
voltages. This is expressed by the formula:
– 12 – IEC 61676:2023 © IEC 2023
ˆˆ
UU−
meas true
I ≤ 0,02
ˆ
U
true
where Û is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and Û is the TRUE VALUE of
meas true
the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are listed in
Table 1.
The compliance test for performance requirement for this subclause is listed under 4.2.2.2.
INTRINSIC ERROR for voltages below 50 kV
4.2.2.2 Maximum
The maximum INTRINSIC ERROR, E, of PRACTICAL PEAK VOLTAGE, Û, measurements made under
STANDARD TEST CONDITIONS shall not be greater than ±1 kV over the EFFECTIVE RANGE of
voltages. This is expressed by the formula:
ˆˆ
EU −≤U 1,0 kV
meas true
where Û is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and Û is the CONVENTIONAL
meas true
TRUE VALUE of the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are
listed in Table 1.
Compliance with performance requirements 4.2.2.1 and 4.2.2.2 shall be checked by measuring
the RELATIVE INTRINSIC ERROR above 50 kV or the INTRINSIC ERROR below 50 kV over the
EFFECTIVE RANGE of voltages for each application claimed. STANDARD TEST CONDITIONS are listed
in Table 2 for each application. The end points of the EFFECTIVE RANGE shall be checked. For
mammography, the nominal step between measurements shall be no greater than 2 kV. For all
other applications the nominal step between measurements shall be no greater than 5 kV for
voltages below 100 kV, and no greater than 10 kV for voltages above 100 kV.
If more than one instrument configuration can be utilised to measure a span of voltages, then
that span of voltages shall be measured utilising all relevant instrument configurations. As a
minimum the end points and enough interim points shall be measured to meet the minimum
step requirements given above. An example could be the use of different absorber pairs to
provide overlapping voltage spans. In the case of different absorber pairs, if the first measured
from 40 kV to 80 kV, and the second from 60 kV to 120 kV, then the overlapping span would be
from 60 kV to 80 kV. At a minimum, measurements would be made utilising each absorber pair
at 60 kV, 65 kV, 70 kV, 75 kV, and 80 kV.
4.2.3 Over and under range indications
The instrument shall clearly indicate when it is displaying a reading outside its EFFECTIVE RANGE
of PRACTICAL PEAK VOLTAGE.
Conditions above and below the EFFECTIVE RANGE of PRACTICAL PEAK VOLTAGE shall be tested
and it shall be demonstrated that if the instrument displays a reading it will be clearly indicated
to the user that the reading might not meet the accuracy of the instrument.
If more than one instrument configuration can be utilised to measure a span of voltages, then
over and under range conditions shall be checked for all relevant instrument configurations. An
example could be the use of different absorber pairs to provide overlapping voltage spans. In
the case of different absorber pairs, if the first measured from 40 kV to 80 kV, and the second
from 60 kV to 120 kV, then over and under range indications would be checked below 40 kV
and above 80 kV for the first absorber pair, and below 60 kV and above 120 kV for the second
absorber pair. (The instrument’s refusal to make a reading under these conditions is an
acceptable result.)
=
=
IEC 61676:2023 © IEC 2023 – 13 –
Compliance with performance requirement of this subclause shall be verified at the lowest limit
of the RATED RANGE of dose rates. All other INFLUENCE QUANTITIES shall be at STANDARD TEST
CONDITIONS as listed in Table 2.
4.2.4 Repeatability
When a measurement is repeated with the same instrument under unaltered conditions, the
COEFFICIENT OF VARIATION shall not exceed ±0,5 % or the standard deviation shall not exceed
0,5 kV, whichever is greater.
Compliance with performance requirement of this subclause shall be checked by determining
the COEFFICIENT OF VARIATION of ten consecutive measurements taken at the lowest limit of the
RATED RANGE of dose rates. All other INFLUENCE QUANTITIES shall be at STANDARD TEST
CONDITIONS as listed in Table 2 for each application. The end points of the EFFECTIVE RANGE and
one point near the middle of the EFFECTIVE RANGE shall be checked. The test shall be conducted
a second time with the dose rate also within STANDARD TEST CONDITIONS.
If more than one instrument configuration can be utilised to measure a span of voltages, then
the end points of that span of voltages shall be measured utilising all relevant instrument
configurations. An example could be the use of different absorber pairs to provide overlapping
voltage spans. In the case of different absorber pairs, if the first measured from 40 kV to 80 kV,
and the second from 60 kV to 120 kV, then the overlapping span would be from 60 kV to 80 kV.
At a minimum, measurements would be made utilising each absorber pair at 60 kV and 80 kV.
4.2.5 Long term stability
The design and construction shall be such that the instrument RESPONSE does not change by
more than ±2,0 % for voltages above 50 kV over a period of one year. For voltages below 50 kV,
the difference between the INDICATED VALUE and CONVENTIONAL TRUE VALUE shall not change by
more than ±1,0 kV over a period of one year.
Compliance with this performance requirement shall be checked by retaining a representative
instrument, stored under STANDARD TEST CONDITIONS of temperature and relative humidity and
by measuring the RELATIVE INTRINSIC ERROR above 50 kV or the INTRINSIC ERROR below 50 kV at
a minimum of two voltages, one near the top and one near the bottom of the EFFECTIVE RANGE.
If more than one instrument configuration can be utilised to measure a span of voltages, then
the end points of that span of voltages shall be measured utilising all relevant instrument
configurations. An example could be the use of different absorber pairs to provide overlapping
voltage spans. In the case of different absorber pairs, if the first measured from 40 kV to 80 kV,
and the second from 60 kV to 120 kV, then the overlapping span would be from 60 kV to 80 kV.
At a minimum, measurements would be made utilising each absorber pair at 60 kV and 80 kV.
These measurements shall be made at a minimum of one-month intervals over a period of not
less than six months. Linear regression analysis shall be used to extrapolate these readings to
obtain the change in RESPONSE over one full year.
4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES
4.3.1 INFLUENCE QUANTITIES
Quantities which can influence the performance of the instrument are given in Table 2.
4.3.2 MINIMUM RATED RANGE of use
The MINIMUM RATED RANGE of use for each of the INFLUENCE QUANTITIES involved is given in
Table 2.
– 14 – IEC 61676:2023 © IEC 2023
4.3.3 REFERENCE CONDITIONS
The REFERENCE CONDITIONS for each particular INFLUENCE QUANTITY are given in Table 2. For
those INFLUENCE QUANTITIES that can be controlled, the REFERENCE VALUE should be the value
used during the CALIBRATION of the equipment.
4.3.4 STANDARD TEST CONDITIONS
The STANDARD TEST CONDITIONS stated in Table 2 shall be met dur
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