EN IEC 61223-3-8:2024
(Main)Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X‑ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022. This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display. This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions. IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X‑ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-8: Abnahme- und Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen für Radiographie und Radioskopie
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-8: Essais d'acceptation et de constance - Performance d'imagerie des appareils à rayonnement X pour la radiographie et la radioscopie
L'IEC 61223-3-8:2024 s’applique à l’évaluation des performances et des paramètres de contrôle de la qualité associés d’imagerie des appareils à rayonnement X pour la radiographie et la radioscopie conformes à l’IEC 60601‑2‑54:2022 ou l’IEC 60601-2-43:2022. Le présent document s’applique à l’évaluation des performances d’imagerie de l’ensemble de la chaîne d’imagerie qui va de l’acquisition de l’image à son affichage, en passant par son traitement. Le présent document s’applique aux essais d’acceptation et aux essais de constance, qui font partie du programme d’assurance de la qualité dans les services d’imagerie médicale et qui sont destinés à être réalisés par ou sous la responsabilité de l’organisme responsable. L’Article A.2 de l’Annexe A présente une discussion détaillée de la place de ces essais dans le cycle de vie des appareils radiologiques médicaux. Les méthodes incluses reposent principalement sur des mesurages non invasifs, exécutés à l’issue de l’installation, en utilisant des équipements d’essai appropriés conformément aux instructions d’installation du fabricant. L’IEC 60601-2-54:2022 et l’IEC 60601-2-43:2022 exigent que des informations soient fournies à l’organisme responsable en ce qui concerne le contrôle de la qualité. Le présent document fournit des recommandations aux fabricants en ce qui concerne les essais d’acceptation et de constance pour les appareils à rayonnement X pris en considération dans le manuel de contrôle de la qualité d’un fabricant. L’Annexe G fournit des recommandations pour un tel manuel.
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del: Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za radiografijo in radioskopijo (IEC 61223-3-8:2024)
Standard IEC 61223-3-8:2024 se uporablja za vrednotenje slikovnega učinka in povezanih parametrov nadzora kakovosti rentgenske opreme za radiografijo in radioskopijo v skladu s standardom IEC 60601-2-54:2022 ali IEC 60601-2-43:2022.
Ta dokument se uporablja za vrednotenje slikovnega učinka v celotni verigi slikanja, od zajema slike, do njene obdelave in prikaza.
Ta dokument se uporablja za preskuse sprejemljivosti in konstantnosti, ki so del programa zagotavljanja kakovosti v medicinskih oddelkih za slikanje ter naj bi jih izvajala odgovorna organizacija oziroma naj bi se izvajali v okviru njene odgovornosti. Podrobna razprava o položaju teh preskusov v življenjskem ciklu medicinske radiološke opreme je podana v točki A.2. Vključene metode temeljijo predvsem na neinvazivnih meritvah z ustrezno preskusno opremo, ki se izvedejo po dokončani namestitvi v skladu z navodili proizvajalca.
Standarda IEC 60601-2-54:2022 in IEC 60601-2-43:2022 določata posredovanje informacij odgovorni organizaciji v zvezi z nadzorom kakovosti. Ta dokument podaja navodila za proizvajalce v zvezi s preskusi sprejemljivosti in konstantnosti za rentgensko opremo v priročniku za nadzor kakovosti, ki ga zagotovi proizvajalec. Dodatek G vsebuje smernice za tak priročnik.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
radiografijo in radioskopijo (IEC 61223-3-8:2024)
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance
and constancy tests - Imaging performance of X-ray equipment for radiography and
radioscopy (IEC 61223-3-8:2024)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-8: Abnahme- und Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von
Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 61223-3-8:2024)
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-8:
Essais d'acceptation et de constance - Performance d'imagerie des appareils à
rayonnement X pour la radiographie et la radioscopie (IEC 61223-3-8:2024)
Ta slovenski standard je istoveten z: EN IEC 61223-3-8:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61223-3-8
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2024
ICS 11.040.50
English Version
Evaluation and routine testing in medical imaging departments -
Part 3-8: Acceptance and constancy tests - Imaging
performance of X-ray equipment for radiography and radioscopy
(IEC 61223-3-8:2024)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-8: Essais d'acceptation et de medizinische Bildgebung - Teil 3-8: Abnahme- und
constance - Performance d'imagerie des appareils à Konstanzprüfungen - Leistungsmerkmale zur Bildgebung
rayonnement X pour la radiographie et la radioscopie von Röntgeneinrichtungen für Radiographie und
(IEC 61223-3-8:2024) Radioskopie
(IEC 61223-3-8:2024)
This European Standard was approved by CENELEC on 2024-04-30. 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61223-3-8:2024 E
European foreword
The text of document 62B/1347/FDIS, future edition 1 of IEC 61223-3-8, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61223-3-8:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-01-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-04-30
document have to be withdrawn
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 61223-3-8:2024 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 60627:2013 NOTE Approved as EN 60627:2015 (not modified)
IEC 61223-3-6:2020 NOTE Approved as EN IEC 61223-3-6:2020 (not modified)
IEC 62220-1-1:2015 NOTE Approved as EN 62220-1-1:2015 (not modified)
IEC 62563-1:2009 NOTE Approved as EN 62563-1:2010 (not modified)
IEC 62563-1:2009/A1:2016 NOTE Approved as EN 62563-1:2010/A1:2016 (not modified)
IEC 62563-1:2009/AMD2:2021 NOTE Approved as EN 62563-1:2010/A2:2021 (not modified)
IEC 62563-2:2021 NOTE Approved as EN IEC 62563-2:2021 (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 60336 2020 Medical electrical equipment - X-ray tube EN IEC 60336 2021
assemblies for medical diagnosis - Focal
spot dimensions and related characteristics
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + corrigendum Mar. 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
IEC 60601-2-43 2022 Medical electrical equipment - Part 2-43: EN IEC 60601-2-43 2023
Particular requirements for the basic safety
and essential performance of X-ray
equipment for interventional procedures
IEC 60601-2-54 2022 Medical electrical equipment - Part 2-54: - -
Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics
IEC 61674 2012 Medical electrical equipment - Dosimeters EN 61674 2013
with ionization chambers and/or
semiconductor detectors as used in X-ray
diagnostic imaging
IEC 61676 2023 Medical electrical equipment - Dosimetric EN IEC 61676 2023
instruments used for non-invasive
measurement of X-ray tube voltage in
diagnostic radiology
IEC 62494-1 2008 Medical electrical equipment - Exposure EN 62494-1 2008
index of digital X-ray imaging systems -
Part 1: Definitions and requirements for
general radiography
IEC 61223-3-8 ®
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Evaluation and routine testing in medical imaging departments –
Part 3-8: Acceptance and constancy tests – Imaging performance of X-ray
equipment for radiography and radioscopy
Essais d'évaluation et de routine dans les services d'imagerie médicale –
Partie 3-8: Essais d'acceptation et de constance – Performance d'imagerie des
appareils à rayonnement X pour la radiographie et la radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-8565-7
– 2 – IEC 61223-3-8:2024 © IEC 2024
CONTENTS
FOREWORD . 8
INTRODUCTION . 10
1 Scope and object . 11
2 Normative references . 11
3 Terms, definitions, symbols and abbreviated terms . 12
3.1 Terms and definitions . 12
3.2 Symbols and abbreviated terms . 21
4 General aspects of ACCEPTANCE TESTING . 21
4.1 General . 21
4.2 Levels of requirements . 22
4.2.1 General . 22
4.2.2 Local regulatory requirements . 22
4.2.3 Contractual requirements . 22
4.2.4 MANUFACTURER specifications . 22
4.3 General conditions in test procedures . 22
4.4 Documents and data for the tests . 22
4.5 Test conditions . 23
4.6 Scope of tests . 25
4.7 Test equipment including PHANTOMS and TEST DEVICES . 26
4.7.1 General . 26
4.7.2 Analysis software. 26
4.7.3 Viewing conditions . 26
4.7.4 High-voltage measuring instrument . 26
4.7.5 DOSIMETER . 26
4.7.6 PHANTOMS, TEST DEVICES and their application . 26
4.8 Evaluating the test results . 29
5 Specific aspects of CONSTANCY TESTING . 29
5.1 General . 29
5.2 Establishment of BASELINE VALUES . 29
5.3 CONSTANCY TESTING and SIMPLE CHECKS . 30
5.4 Frequency of CONSTANCY TESTS . 30
6 Summary of tests for X‑RAY EQUIPMENT . 30
7 Requirements and test methods . 32
7.1 General . 32
7.2 Functional properties . 33
7.2.1 Test requirements . 33
7.2.2 Test method for ACCEPTANCE TEST . 33
7.2.3 Test method for CONSTANCY TEST . 33
7.3 IMAGE DISPLAY DEVICE performance . 33
7.3.1 Test requirements . 33
7.3.2 Test method for ACCEPTANCE TEST . 33
7.3.3 Test method for CONSTANCY TEST . 34
7.4 X‑RAY TUBE VOLTAGE . 34
7.4.1 Test requirements . 34
7.4.2 Test method for ACCEPTANCE TEST .
...
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