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 (informati
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.