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

Status
Published
Publication Date
11-May-2023
Current Stage
6060 - Document made available - Publishing
Start Date
12-May-2023
Completion Date
12-May-2023

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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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...

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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oSIST prEN IEC 61676:2022

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oSIST prEN IEC 61676:2022
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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oSIST prEN IEC 61676:2022

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oSIST prEN IEC 61676:2022
62C/830/CDV – 2 – IEC CDV 61676 © IEC 2021

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 .
...

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