SIST EN IEC 61676:2023
(Main)Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2023)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2023)
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.
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.
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)
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
SIST EN IEC 61676:2023
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
SIST EN IEC 61676:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 61676:2023
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SIST EN IEC 61676:2023
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
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SIST EN IEC 61676:2023
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
EN IEC 61676:2023.
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)
2
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SIST EN IEC 61676:2023
EN IEC 61676:2023 (E)
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
3
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SIST EN IEC 61676:2023
EN IEC 61676:2023 (E)
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
4
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SIST EN IEC 61676:2023
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 61676:2023
– 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
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SIST EN IEC 61676:2023
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
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SIST EN IEC 61676:2023
– 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".
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SIST EN IEC 61676:2023
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.
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SIST EN IEC 61676:2023
– 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.
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SIST EN IEC 61676:2023
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
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SIST EN IEC 61676:2023
– 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 def
...
SLOVENSKI STANDARD
oSIST prEN IEC 61676:2022
01-marec-2022
Medicinska električna oprema - Dozimetrijska oprema za posredno merjenje
napetosti rentgenske elektronke v diagnostični radiologiji
Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
Medizinische elektrische Geräte - Geräte für die nicht-invasive Messung der
Röntgenröhrenspannung in der diagnostischen Radiologie
Appareils électromédicaux - Instruments de dosimétrie pour la mesure non invasive de la
tension du tube radiogène dans la radiologie de diagnostic
Ta slovenski standard je istoveten z: prEN IEC 61676:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
17.240 Merjenje sevanja Radiation measurements
oSIST prEN IEC 61676:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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62C/830/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61676 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-01-21 2022-04-15
SUPERSEDES DOCUMENTS:
62C/796A/CD, 62C/808A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62B
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
TITLE:
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray
tube voltage in diagnostic radiology
PROPOSED STABILITY DATE: 2026
NOTE FROM TC/SC OFFICERS:
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download
this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee
positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other
purpose without permission in writing from IEC.
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1 CONTENTS
2 FOREWORD . 4
3 INTRODUCTION . 6
4 1 Scope and object . 7
5 2 Normative references . 7
6 3 Terminology and definitions . 8
7 4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE
8 measurements . 10
9 4.1 Quantity to be measured . 10
10 4.2 Limits of PERFORMANCE CHARACTERISTICs . 11
11 4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES . 13
12 4.4 Performance test procedures . 15
13 5 Special instrumental requirements and marking . 22
14 5.1 Requirements for the complete instruments . 22
15 5.2 General . 22
16 5.3 Display . 22
17 5.4 Range of measurement . 22
18 5.5 Connectors and cables . 22
19 6 ACCOMPANYING DOCUMENTS . 22
20 6.1 General . 22
21 6.2 Information provided . 22
22 6.3 Instrument description . 22
23 6.4 Detector . 23
24 6.5 Delay time . 23
25 6.6 Measurement window . 23
26 6.7 Data outlet . 23
27 6.8 Transport and storage . 23
28 Annex A (informative) COMBINED STANDARD UNCERTAINTY . 24
29 Annex B (informative) Additional information on PRACTICAL PEAK VOLTAGE . 25
30 INDEX OF DEFINED TERMS . 31
31
32 Figure B.1 – Example of a waveform of a two-pulse generator . 27
33 Figure B.2 – Example of a waveform of a constant-voltage generator . 27
34 Figure B.3 – Example of falling load waveform . 28
35
36 Table 1 – MINIMUM EFFECTIVE RANGES . 11
37 Table 2 – Minimum RATED RANGE OF USE, REFERENCE CONDITIONS, STANDARD TEST
38 CONDITIONS, LIMITS OF VARIATION ( L) and INTRINSIC ERROR (E) over the EFFECTIVE
39 RANGE of use, for the pertaining INFLUENCE QUANTITY . 14
40 Table 3 – Minimum test points and test values of PRACTICAL PEAK VOLTAGE for
41 INFLUENCE QUANTITIES . 15
42 Table 4 – Maximum HALF-VALUE LAYER (HVL) depending on anode angle . 21
43 Table B.1 – Values of 20 samples of the falling load waveform in figure B.3 . 28
44 Table B.2 – Voltage bins, probability and weighting factors for the 20 samples of the
45 falling load waveform in figure B.3 . 29
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46 Table B.3 – Weighting factors for the 20 equally spaced samples of the falling load
47 waveform in figure B.3 . 30
48
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49 INTERNATIONAL ELECTROTECHNICAL COMMISSION
50 ⎯⎯⎯⎯⎯
51 MEDICAL ELECTRICAL EQUIPMENT –
52
53 Dosimetric instruments used for non-invasive measurement
54 of X-ray tube voltage in diagnostic radiology
55
56
57 FOREWORD
58 1) The International Electrotechnical Commission (IEC) is a worldwide organization for st andardization comprising
59 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
60 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
61 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
62 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
63 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
64 in the subject dealt with may participate in this preparatory work. International, governmental and non-
65 governmental organizations liaising with the IEC also participate in this preparation. IEC collabora tes closely
66 with the International Organization for Standardization (ISO) in accordance with conditions determined by
67 agreement between the two organizations.
68 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
69 consensus of opinion on the relevant subjects since each technical committee has re presentation from all
70 interested IEC National Committees.
71 3) IEC Publications have the form of recommendations for international use and are accepted by I EC National
72 Committees in that sense. While all reasonable efforts are made to ensure that the techni cal content of IEC
73 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
74 misinterpretation by any end user.
75 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Pub lications
76 transparently to the maximum extent possible in their national and regional publications. Any divergence
77 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
78 the latter.
79 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
80 equipment declared to be in conformity with an IEC Publication.
81 6) All users should ensure that they have the latest edition of this publication.
82 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
83 members of its technical committees and IEC National Committees for any personal injury, property damage or
84 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
85 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
86 Publications.
87 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
88 indispensable for the correct application of this publication.
89 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
90 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
91 International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment
92 for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62:
93 Electrical equipment in medical practice.
94 This second edition of IEC 61676 cancels and replaces the edition 1.1, published in 2009. It
95 includes an assessment of the COMBINED STANDARD UNCERTAINTY for the performance of a
96 hypothetical instrument for the non-invasive measurement of the tube high voltage (in
97 Annex A) which replaces Annex A of the edition 1.1 titled “Recommended performance criteria
98 for the invasive divider”.
99
100
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101 In this standard the following print types are used:
102 − requirements, compliance with which can be tested, and definitions: in roman type;
103 − notes, explanations, advice, general statements and exceptions: in small roman type;
104 − test specifications: in italic type;
105 − TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC
106 60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS.
107 The committee has decided that the contents of the base publication and its amendments will
108 remain unchanged until the maintenance result date indicated on the IEC web site under
109 "http://webstore.iec.ch" in the data related to the specific publication. At this date,
110 the publication will be
111 • reconfirmed,
112 • withdrawn,
113 • replaced by a revised edition, or
114 • amended.
115 A bilingual version of this publication may be issued at a later date.
116 NOTE The committee knows this second edition of the standard does still not address all problems associated
117 with non-invasive high voltage measurements. For mammography only molybdenum filtration is considered in
118 conjunction with a molybdenum anode although in addition tungsten and rhodium anodes with other filtrations are
119 in use like rhodium, aluminium, copper, silver or titanium. At the time when this document was drafted there were
120 not enough data available in the literature to define realistic limits of variation for these types of INFLUENCE
121 QUANTITIES. On the other hand, the committee was informed that several international projects were started to
122 examine the general behaviour of non-invasive X-ray multimeters of the main manufacturers. Results from these
123 studies were to be expected within about 5 years. Therefore, the committee decided to set a short stability time for
124 the second edition and update the standard as soon as the results from these new examinations will be available.
125
126
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127 INTRODUCTION
128 The result of a measurement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive
129 instruments is normally expressed in the form of one single number for the value of the tube
130 voltage, irrespective of whether the tube voltage is constant potential or shows a time
131 dependent waveform. Non-invasive instruments for the measurement of the X-RAY TUBE
132 VOLTAGE on the market usually indicate the “mean peak voltage”. But the quantity “mean peak
133 voltage” is not unambiguously defined and may be any mean of all voltage peaks. It is
134 impossible to establish test procedures for the performance requirements of non-invasive
135 instruments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the
136 quantity under consideration. Therefore, this standard is based on a quantity called
137 "PRACTICAL PEAK VOLTAGE". The PRACTICAL PEAK VOLTAGE is unambiguously defined and
138 applicable to any waveform. This quantity is related to the spectral distribution of the emitted
139 X-RADIATION and the image properties. X-RAY GENERATORS operating at the same value of the
140 PRACTICAL PEAK VOLTAGE will produce the same low-level contrast in the RADIOGRAMS, even
141 when the waveforms of the tube voltages are different. Detailed information on this concept is
142 provided in Annex B. An example for the calculation of the PRACTICAL PEAK VOLTAGE in the
143 case of a “falling load” waveform is also given in Annex B.
144 The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is
145 generally performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments
146 utilising NON-INVASIVE MEASUREMENTS can also be used to check the calibration or to adjust
147 the X-RAY TUBE VOLTAGE. These instruments are required to have uncertainties of the voltage
148 measurement comparable with the INVASIVE MEASUREMENT. One of the most important
149 parameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because
150 both the image quality in diagnostic radiology and the DOSE received by the PATIENT
151 undergoing radiological examinations are dependent on the X-RAY TUBE VOLTAGE. An overall
152 uncertainty below ±5 % is required, and this value serves as a guide for the LIMITS OF
153 VARIATION for the effects of INFLUENCE QUANTITIES.
154
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155 MEDICAL ELECTRICAL EQUIPMENT –
156
157 Dosimetric instruments used for non-invasive measurement
158 of X-ray tube voltage in diagnostic radiology
159
160
161
162 1 Scope and object
163 This International Standard specifies the performance requirements of instruments as used in
164 the NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE up to 150 kV and the relevant
165 compliance tests. This standard also describes the method for calibration and gives guidance
166 for estimating the uncertainty in measurements performed under conditions different from
167 those during calibration.
168 Applications for such measurement are found in diagnostic RADIOLOGY including
169 mammography, COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY. This standard
170 is not concerned with the safety aspect of such instruments. The requirements for electrical
171 safety applying to them are contained in IEC 61010-1.
172 2 Normative references
173 The following documents are referred to in the text in such a way that some or all of their
174 content constitutes requirements of this document. For dated references, only the edition
175 cited applies. For undated references, the latest edition of the referenced document (including
176 any amendments) applies.
177 IEC 60417, Graphical symbols for use on equipment (available at http://www.graphical-
178 symbols.info/equipment)
179 IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
180 IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement
181 techniques – Electrostatic discharge immunity test
182 IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
183 techniques – Radiated, radio-frequency, electromagnetic field immunity test
184 IEC 61000-4-4, Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement
185 techniques – Electrical fast transient/burst immunity test
186 IEC 61000-4-5, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement
187 techniques – Surge immunity test
188 IEC 61000-4-6, Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement
189 techniques – Immunity to conducted disturbances induced by radio-frequency fields
190 IEC 61000-4-11, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement
191 techniques – Voltage dips, short interruptions and voltage variations immunity tests
192 IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and
193 laboratory use – Part 1: General requirements
194 IEC 61187, Electrical and electronic measuring equipment – Documentation
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195 ISO 7000:1989, Graphical symbols for use on equipment – Index and synopsis
196 3 Terminology and definitions
197 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
198 IEC TR 60788:2004 and the following apply.
199 ISO and IEC maintain terminological databases for use in standardization at the following
200 addresses:
201 • IEC Electropedia: available at http://www.electropedia.org/
202 • ISO Online browsing platform: available at http://www.iso.org/obp
203 NOTE 1 An index of defined terms is to be found at the end of the document.
204 NOTE 2 A searchable IEC Glossary can be found at std.iec.ch
205 3.1
206 CORRECTION FACTOR
207 dimensionless multiplier which corrects the INDICATED VALUE of an instrument from its value
208 when operated under particular conditions to its value when operated under stated REFERENCE
209 CONDITIONS
210 3.2
211 EFFECTIVE RANGE
212 range of INDICATED VALUES for which an instrument complies with a stated performance. The
213 maximum (minimum) effective INDICATED VALUE is the highest (lowest) in this range
214 3.3
215 INDICATED VALUE
216 value of quantity derived from the scale reading of an instrument together with any scale
217 factors indicated on the control panel of the instrument
218 3.4
219 INFLUENCE QUANTITY
220 any external quantity that may affect the performance of an instrument (e.g., ambient
221 temperature etc.) and any property of the X-RAY EQUIPMENT under test that needs to be taken
222 into account in using the instrument for NON-INVASIVE MEASUREMENT of X-RAY TUBE VOLTAGE
223 (e.g., range of X-RAY TUBE VOLTAGE, ANODE ANGLE, anode material, TOTAL FILTRATION etc.)
224 3.5
225 INSTRUMENT PARAMETER
226 any internal property of an instrument that may affect the performance of the instrument
227 3.6
228 INTRINSIC ERROR
229 deviation of the MEASURED VALUE (i.e., the INDICATED VALUE, corrected to REFERENCE
230 CONDITIONS) from the CONVENTIONAL TRUE VALUE under STANDARD TEST CONDITIONS
231 3.7
232 INVASIVE MEASUREMENT
233 measurement of the X-RAY TUBE VOLTAGE by external connection of a suitable meter or a high
234 resistance divider
235 3.8
236 LIMITS OF VARIATION
237 maximum VARIATION of a PERFORMANCE CHARACTERISTIC y, permitted by this standard. If the
238 LIMITS OF VARIATION are stated as ±L % the VARIATION y / y, expressed as a percentage, shall
239 remain in the range from −L % to +L %
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240 3.9
241 MAXIMUM PEAK VOLTAGE
242 maximum value of the X-RAY TUBE VOLTAGE in a specified time interval. The unit of this
243 quantity is the volt (V)
244 3.10
245 MEAN PEAK VOLTAGE
246 mean value of all X-RAY TUBE VOLTAGE peaks during a specified time interval. The unit of this
247 quantity is the volt (V)
248 3.11
249 MEASURED VALUE
250 best estimate of the CONVENTIONAL TRUE VALUE of a quantity, being derived from the INDICATED
251 VALUE of an instrument together with the application of all relevant CORRECTION FACTORS
252 NOTE The CONVENTIONAL TRUE VALUE will usually be the value determined by the working standard with which the
253 instrument under test is being compared.
254 3.12
255 MINIMUM EFFECTIVE RANGE
256 smallest permitted range of INDICATED VALUES for which an instrument complies with a stated
257 performance
258 3.13
259 NON-INVASIVE MEASUREMENT
260 measurement of X-RAY TUBE VOLTAGE by analysis of the emitted RADIATION
261 3.14
262 PERFORMANCE CHARACTERISTIC
263 one of the quantities used to define the performance of an instrument (e.g., RESPONSE)
264 3.15
265 VOLTAGE RIPPLE
266 VOLTAGE RIPPLE at the X-RAY TUBE, r, is expressed as a percentage of the peak voltage, U ,
max
267 over a specified time interval. This is expressed by the formula:
U − U
max min
268 r = 100%
U
max
269 where U is the highest voltage in the interval, and U is the lowest voltage in the interval
max min
270 3.16
271 PRACTICAL PEAK VOLTAGE (PPV)
ˆ
U
272 PRACTICAL PEAK VOLTAGE is defined as:
U
max
p(U) w(U) U dU
U
max
U
ˆ min
273 U = with p(U) dU = 1
U
max
U
min
p(U) w(U) dU
U
min
274 where p(U) is the distribution function for the voltage U and w(U) is a weighting function. Umax
275 is the highest voltage in the interval, and U is the lowest voltage in the interval. The unit of
min
276 the quantity PRACTICAL PEAK VOLTAGE is the volt (V)
277 NOTE Additional information on the PRACTICAL PEAK VOLTAGE, the weighting function w(U) and the distribution
278 function p(U) is provided in Annex C. Using this weighting function w(U) the PRACTICAL PEAK VOLTAGE will be
279 defined as the constant potential which produces the same AIR KERMA contrast behind a specified PHANTOM as the
280 non-dc voltage under test.
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281 3.17
282 RATED RANGE (of use)
283 range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER within which the
284 instrument will operate within the LIMITS OF VARIATION. Its limits are the maximum and
285 minimum RATED values.
286 The MINIMUM RATED RANGE is the least range of an INFLUENCE QUANTITY or INSTRUMENT
287 PARAMETER within which the instrument shall operate within the specified LIMITS OF VARIATION
288 in order to comply with this standard
289 3.18
290 REFERENCE CONDITIONS
291 conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
292 REFERENCE VALUES
293 3.19
294 REFERENCE VALUE
295 particular value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) chosen for the
296 purposes of reference i.e., the value of an INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) at
297 which the CORRECTION FACTOR for dependence on that INFLUENCE QUANTITY (or INSTRUMENT
298 PARAMETER) is unity
299 3.20
300 RELATIVE INTRINSIC ERROR
301 ratio of the INTRINSIC ERROR to the CONVENTIONAL TRUE VALUE
302 3.21
303 RESPONSE
304 quotient of the INDICATED VALUE divided by the CONVENTIONAL TRUE VALUE
305 3.22
306 STANDARD TEST CONDITIONS
307 conditions under which all INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS have their
308 STANDARD TEST VALUES
309 3.23
310 STANDARD TEST VALUES
311 value, values, or a range of values of an INFLUENCE QUANTITY or INSTRUMENT PARAMETER,
312 which is/are permitted when carrying out calibrations or tests on another INFLUENCE QUANTITY
313 or INSTRUMENT PARAMETER
314 3.24
315 VARIATION
316 relative difference y / y, between the values of a PERFORMANCE CHARACTERISTIC y, when one
317 INFLUENCE QUANTITY (or INSTRUMENT PARAMETER) assumes successively two specified values,
318 the other INFLUENCE QUANTITIES (and INSTRUMENT PARAMETERS) being kept constant at the
319 STANDARD TEST VALUES (unless other values are specified)
320 3.25
321 X-RAY TUBE VOLTAGE
322 potential difference applied to an X-RAY TUBE between the anode and the cathode. The unit of
323 this quantity is the volt (V)
324 4 General performance requirements for measurement of PRACTICAL PEAK
325 VOLTAGE measurements
326 4.1 Quantity to be measured
327 The quantity to be measured is the PRACTICAL PEAK VOLTAGE.
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328 NOTE Additional quantities may be displayed.
329 The MINIMUM EFFECTIVE RANGES of PRACTICAL PEAK VOLTAGE shall be as listed in table 1 for the
330 relevant X-RAY applications.
331 Table 1 – MINIMUM EFFECTIVE RANGES
Application Nominal anode material MINIMUM EFFECTIVE RANGE
Mammography
a)
24 kV to 35 kV
Mo
(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.
332
333 4.2 Limits of PERFORMANCE CHARACTERISTICs
334 4.2.1 Limits
335 All values of the limits of PERFORMANCE CHARACTERISTICS stated in this subclause do not
336 contain the uncertainty of the test equipment.
337 4.2.2 Maximum error
338 4.2.2.1 Maximum RELATIVE INTRINSIC ERROR for voltages above 50 kV
ˆ
339 The RELATIVE INTRINSIC ERROR, l, of PRACTICAL PEAK VOLTAGE, , measurements made under
U
340 STANDARD TEST CONDITIONS, shall not be greater than ±2 % over the EFFECTIVE RANGE of
341 voltages. This is expressed by the formula:
ˆ ˆ
U − U
meas true
342 I = 0,02
ˆ
U
true
ˆ ˆ
343 where U is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and U is the true value of
meas true
344 the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are listed in
345 table 1.
346 The compliance test for performance requirement 4.2.2.1 is listed under 4.2.2.2.
347 4.2.2.2 Maximum INTRINSIC ERROR for voltages below 50 kV
ˆ
348 The maximum INTRINSIC ERROR, E, of PRACTICAL PEAK VOLTAGE, , measurements made under
U
349 STANDARD TEST CONDITIONS shall not be greater than ±1 kV over the EFFECTIVE RANGE of
350 voltages. This is expressed by the formula:
ˆ ˆ
351
E = U − U 1,0 kV
meas true
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ˆ ˆ
352 where is the MEASURED VALUE of PRACTICAL PEAK VOLTAGE and is the conventional
U U
meas true
353 true value of the PRACTICAL PEAK VOLTAGE. The voltages for the MINIMUM EFFECTIVE RANGE are
354 listed in table 1.
355 C
...
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