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
Overview
EN IEC 61223-3-8:2024 (IEC 61223-3-8:2024) defines acceptance and constancy tests for evaluating the imaging performance of X‑ray equipment for radiography and radioscopy. It applies to systems that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022, and covers the entire imaging chain: image acquisition, image processing and image display. The standard concentrates on non‑invasive measurements performed after installation (per manufacturer instructions) and is intended for use within the responsible organisation’s quality assurance (QA) programme. Annex G gives guidance on a manufacturer‑supplied quality control manual.
Key technical topics and requirements
- Acceptance vs. constancy testing: Defines scope, conditions and responsibilities for initial acceptance tests and routine constancy checks that maintain imaging performance over time.
- Whole imaging chain coverage: Tests apply from detector/tube through processing algorithms to display devices.
- Baseline values and frequency: Establishment of baseline performance and recommended constancy test intervals (see Clause 5).
- Test equipment and phantoms: Use of phantoms, dosimeters, high‑voltage meters, focal spot measurement tools, display test patterns and analysis software.
- Measured parameters (illustrative topics in Clause 7):
- X‑ray tube voltage and current / current‑time product
- Half‑value layer (HVL) and filtration equivalence
- Focal spot characteristics and geometrical accuracy
- Automatic exposure/control system performance and reproducibility
- Correspondence of X‑ray field to receptor area and light field accuracy
- Image display device performance and viewing conditions
- Non‑invasive methods: Emphasis on methods that do not alter equipment, suitable for clinical environments.
- Manufacturer guidance: Requirements for information manufacturers must provide to the responsible organisation; Annex G guides QC manual content.
Practical applications - who uses this standard
- Medical physicists and clinical engineers - design and execute acceptance and constancy tests, set baseline values, interpret test results.
- Radiology department QA managers and radiographers - perform routine checks and simple constancy tests.
- Manufacturers - prepare manufacturer‑supplied quality control manuals and provide QC information required by IEC 60601‑2‑54 / -2‑43.
- Regulators and auditors - assess compliance with safety and performance requirements during commissioning and periodic inspection.
Related standards (selection)
- IEC 60601-2-54:2022, IEC 60601-2-43:2022 (equipment particular requirements)
- IEC 61267 (radiation conditions), IEC 61674, IEC 61676 (dosimetry)
- IEC 62494-1 (exposure index), IEC 60336 (focal spot)
These referenced standards complement IEC 61223-3-8:2024 for comprehensive QA of radiographic and radioscopic X‑ray equipment.
Keywords: IEC 61223-3-8:2024, SIST EN IEC 61223-3-8, acceptance tests, constancy tests, X‑ray equipment, radiography, radioscopy, quality control, medical imaging, phantoms, dosimeter, baseline values.
Frequently Asked Questions
EN IEC 61223-3-8:2024 is a standard published by CLC. Its full title is "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". This standard covers: 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.
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.
EN IEC 61223-3-8:2024 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase EN IEC 61223-3-8:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.
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 . 34
7.4.3 Test method for CONSTANCY TEST . 35
IEC 61223-3-8:2024 © IEC 2024 – 3 –
7.5 X‑RAY TUBE CURRENT or CURRENT TIME PRODUCT . 35
7.5.1 Test requirements . 35
7.5.2 Test method for ACCEPTANCE TEST . 35
7.5.3 Test method for CONSTANCY TEST . 35
7.6 HALF-VALUE LAYER of the X‑RAY SOURCE ASSEMBLY . 35
7.6.1 Test requirements . 35
7.6.2 Test method for ACCEPTANCE TEST . 36
7.6.3 Test method for CONSTANCY TEST . 36
7.7 * QUALITY EQUIVALENT FILTRATION of ADDED FILTERS . 36
7.7.1 Test requirements . 36
7.7.2 * Test method for ACCEPTANCE TEST . 36
7.7.3 Test method for CONSTANCY TEST . 36
7.8 * ATTENUATION EQUIVALENT of materials between the PATIENT and the X‑RAY
IMAGE RECEPTOR . 36
7.8.1 Test requirements . 36
7.8.2 * Test method for ACCEPTANCE TEST . 37
7.8.3 Test method for CONSTANCY TEST . 37
7.9 FOCAL SPOT of the X‑RAY TUBE . 37
7.9.1 Test requirements . 37
7.9.2 Test method for ACCEPTANCE TEST . 37
7.9.3 Test method for CONSTANCY TEST . 37
7.10 Assessing geometrical properties of the X-RAY EQUIPMENT . 37
7.10.1 Test requirements . 37
7.10.2 Test method for ACCEPTANCE TEST . 37
7.10.3 Test method for CONSTANCY TEST . 37
7.11 AUTOMATIC CONTROL SYSTEM ─ Performance . 38
7.11.1 Test requirements . 38
7.11.2 * Test method for ACCEPTANCE TEST . 38
7.11.3 * Test method for CONSTANCY TEST . 38
7.12 AUTOMATIC CONTROL SYSTEM ─ Reproducibility . 38
7.12.1 Test requirements . 38
7.12.2 Test method for ACCEPTANCE TEST . 38
7.12.3 Test method for CONSTANCY TEST . 38
7.13 * AUTOMATIC CONTROL SYSTEM – NOMINAL SHORTEST IRRADIATION TIME . 38
7.13.1 Test requirements . 38
7.13.2 * Test method for ACCEPTANCE TEST . 38
7.13.3 Test method for CONSTANCY TEST . 39
7.14 Correspondence between the X‑RAY FIELD and EFFECTIVE IMAGE RECEPTION
AREA . 39
7.14.1 Test requirements . 39
7.14.2 Test method for ACCEPTANCE TEST . 40
7.14.3 Test method for CONSTANCY TEST . 41
7.15 Accuracy of indication of the LIGHT FIELD-INDICATOR . 41
7.15.1 Test requirements . 41
7.15.2 Test method for ACCEPTANCE TEST . 42
7.15.3 Test method for CONSTANCY TEST . 42
7.16 Accuracy of marked and written indications of the X‑RAY FIELD size . 43
7.16.1 Test requirements . 43
7.16.2 Test method for ACCEPTANCE TEST . 43
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7.16.3 Test method for CONSTANCY TEST . 43
7.17 AIR KERMA RATE at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR for
RADIOSCOPY. 43
7.17.1 Test requirements . 43
7.17.2 Test method for ACCEPTANCE TEST . 44
7.17.3 Test method for CONSTANCY TEST . 44
7.18 REFERENCE AIR KERMA RATE for RADIOSCOPY . 44
7.18.1 Test requirements . 44
7.18.2 Test method for ACCEPTANCE TEST . 44
7.18.3 Test method for CONSTANCY TEST . 45
7.19 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR for
RADIOGRAPHY . 46
7.19.1 Test requirements . 46
7.19.2 Test method for ACCEPTANCE TEST . 46
7.19.3 Test method for CONSTANCY TEST . 46
7.20 REFERENCE AIR KERMA for SERIAL RADIOGRAPHY . 46
7.20.1 Test requirements . 46
7.20.2 Test method for ACCEPTANCE TEST . 46
7.20.3 Test method for CONSTANCY TEST . 46
7.21 Limitation of the REFERENCE AIR KERMA RATE in RADIOSCOPY . 46
7.21.1 Test requirements . 46
7.21.2 Test method for ACCEPTANCE TEST . 46
7.21.3 Test method for CONSTANCY TEST . 47
7.22 SPATIAL RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 47
7.22.1 Test requirements . 47
7.22.2 Test method for ACCEPTANCE TEST . 47
7.22.3 Test method for CONSTANCY TEST . 49
7.23 LOW CONTRAST RESOLUTION for RADIOSCOPY and RADIOGRAPHY . 49
7.23.1 Test requirements . 49
7.23.2 Test method for ACCEPTANCE TEST . 50
7.23.3 Test method for CONSTANCY TEST . 50
7.24 DYNAMIC RANGE for RADIOSCOPY and RADIOGRAPHY . 50
7.24.1 Test requirements . 50
7.24.2 Test method for ACCEPTANCE TEST . 51
7.24.3 Test method for CONSTANCY TEST . 51
7.25 DOSE AREA PRODUCT and REFERENCE AIR KERMA (RATE) indicator . 51
7.25.1 Test requirements . 51
7.25.2 Test method for ACCEPTANCE TEST . 51
7.25.3 Test method for CONSTANCY TEST . 51
7.26 Back-up timer and safety measures . 51
7.26.1 Test requirements . 51
7.26.2 Test method for ACCEPTANCE TEST . 51
7.26.3 Test method for CONSTANCY TEST . 52
7.27 ARTEFACTS . 52
7.27.1 Test requirements . 52
7.27.2 Test method for ACCEPTANCE TEST . 52
7.27.3 Test method for CONSTANCY TEST . 53
7.28 Accuracy of image measuring functions . 53
7.28.1 Test requirements . 53
IEC 61223-3-8:2024 © IEC 2024 – 5 –
7.28.2 Test method for ACCEPTANCE TEST . 53
7.28.3 Test method for CONSTANCY TEST . 53
7.29 DYNAMIC RANGE for SUBTRACTION IMAGING . 53
7.29.1 Test requirements . 53
7.29.2 Conditions for testing the SUBTRACTION IMAGING mode . 53
7.29.3 Test method for ACCEPTANCE TEST . 53
7.29.4 Test method for CONSTANCY TEST . 54
7.30 Contrast sensitivity for SUBTRACTION IMAGING . 54
7.30.1 Test requirements . 54
7.30.2 Test method for ACCEPTANCE TEST . 54
7.30.3 Test method for CONSTANCY TEST . 54
7.31 SPATIAL RESOLUTION for SUBTRACTION IMAGING . 54
7.31.1 Test requirements . 54
7.31.2 Test method for ACCEPTANCE TEST . 55
7.31.3 Test method for CONSTANCY TEST . 55
7.32 ARTEFACTS in SUBTRACTION IMAGING . 55
7.32.1 Test requirements . 55
7.32.2 Test method for ACCEPTANCE TEST . 55
7.32.3 Test method for CONSTANCY TEST . 55
7.33 X‑RAY IMAGE RECEPTOR EXPOSURE INDEX . 55
7.33.1 Test requirements . 55
7.33.2 Test method for ACCEPTANCE TEST . 56
7.33.3 Test method for CONSTANCY TEST . 56
7.34 LEAKAGE RADIATION in the LOADING STATE . 57
7.34.1 Test requirements . 57
7.34.2 Test method for ACCEPTANCE TEST . 57
7.34.3 Test method for CONSTANCY TEST . 57
Annex A (informative) General guidance and rationale . 58
A.1 Aim and background information . 58
A.2 Medical radiological equipment lifecycle testing . 58
A.2.1 General . 58
A.2.2 The "lifecycle" . 58
A.3 Rationale for particular clauses and subclauses . 61
Annex B (informative) Use of REFERENCE AIR KERMA and AIR KERMA at the ENTRANCE
PLANE of the X‑RAY IMAGE RECEPTOR . 64
B.1 General . 64
B.2 Issues with AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR
as a measure of performance . 64
B.3 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR as an
ACCEPTANCE TEST or CONSTANCY TEST . 64
B.4 REFERENCE AIR KERMA as a measure of performance . 65
B.5 REFERENCE AIR KERMA as an ACCEPTANCE TEST . 65
Annex C (informative) Assessing clinical protocol performance . 66
C.1 General . 66
C.2 Discussion . 66
Annex D (informative) Examples of TEST DEVICES for image quality evaluation . 67
D.1 General . 67
D.2 TEST DEVICE according to DIN 6868-150 . 67
D.3 Leeds X‑ray test objects for RADIOGRAPHY/RADIOSCOPY systems . 67
– 6 – IEC 61223-3-8:2024 © IEC 2024
D.4 LOW CONTRAST RESOLUTION TEST DEVICE of the University of Alabama at
Birmingham, USA. 67
Annex E (informative) Examples of DSA PHANTOMS . 69
E.1 General . 69
E.2 Generic DSA PHANTOM . 69
E.3 DSA PHANTOM with test step for compensation . 71
Annex F (informative) QUALITY CONTROL in cone beam computed tomography (CBCT) . 73
F.1 General . 73
F.2 Image quality parameters . 73
F.2.1 Summary of tests for CBCT . 73
F.2.2 Uniformity . 73
F.2.3 Geometrical precision . 74
F.2.4 Voxel density values . 75
F.2.5 Noise . 75
F.2.6 LOW CONTRAST RESOLUTION . 75
F.2.7 SPATIAL RESOLUTION . 76
F.3 Tests of RADIATION output . 76
F.3.1 General . 76
F.3.2 Cumulative DOSE AREA PRODUCT . 77
F.3.3 AIR KERMA at the ENTRANCE PLANE of the X‑RAY IMAGE RECEPTOR . 78
F.3.4 In-phantom dosimetry indexes – CTDI metrics . 78
F.3.5 Cumulative AIR KERMA . 79
F.4 Image quality PHANTOMS . 79
Annex G (informative) Guidance for MANUFACTURER supplied QUALITY CONTROL manual. 80
G.1 General . 80
G.2 Generic considerations for a QUALITY CONTROL manual . 80
G.3 Prerequisites for guidance for MANUFACTURER supplied QUALITY CONTROL
manual . 80
G.3.1 General . 80
G.3.2 General aspects . 81
G.3.3 Objective of test . 81
G.3.4 Test methods, test equipment and test objects . 81
G.3.5 Frequency of test . 81
G.3.6 Acceptance and constancy criteria . 81
G.4 Example of a QUALITY CONTROL manual for a DOSE AREA PRODUCT verification . 82
Annex H (informative) Uncertainty aspects of testing on X‑RAY EQUIPMENT for
RADIOGRAPHY and RADIOSCOPY . 84
H.1 General . 84
H.2 Measurements performed in a clinical facility . 85
H.3 Measurements made by placing a probe in the X‑RAY BEAM . 85
H.3.1 General . 85
H.3.2 Direct setting of the X‑ray equipment . 86
H.3.3 Indirect setting of the X‑ray equipment . 86
Annex I (informative) Examples of SIMPLE CHECKS . 87
I.1 General . 87
I.2 Examples of visual inspection . 87
I.3 Examples of indicated values of parameters . 87
Annex J (informative) Examples of system changes and relevant ACCEPTANCE TESTS . 89
Bibliography . 90
IEC 61223-3-8:2024 © IEC 2024 – 7 –
Index of defined terms . 93
Figure 1 – Indicative measuring arrangement for RADIOGRAPHY and RADIOSCOPY
equipment for AIR KERMA measurements. 24
Figure 2 – Indicative measuring arrangement for RADIOGRAPHY and RADIOSCOPY
equipment to test geometry and resolutions . 25
Figure 3 – Example of a LINE PAIR RESOLUTION TEST DEVICE . 28
Figure 4 – MODULATION TRANSFER FUNCTION TEST DEVICE . 28
Figure 5 – Discrepancies in covering the IMAGE RECEPTION AREA . 41
Figure 6 – Discrepancies in visual indication of the X‑RAY FIELD . 42
Figure A.1 – Lifecycle of X‑ray imaging equipment . 59
Figure E.1 – Generic DSA PHANTOM . 70
Figure E.2 – DSA PHANTOM with test step for compensation . 72
Figure F.1 – Position of the ROIs for the calculation of the uniformity . 74
Figure F.2 – CTDI PHANTOM with the positions of the DOSIMETER . 78
Figure G.1 – Measurement set-up for DAP measurement . 82
Figure H.1 – Decision points with respect to MEASUREMENT UNCERTAINTY. 85
Table 1 – QUALITY CONTROL tests and recommended frequencies . 31
Table E.1 – Summary of properties of the generic DSA PHANTOM. . 69
Table E.2 – Summary of properties of the DSA PHANTOM with test step for compensation. 71
Table F.1 – Summary of image quality tests for CBCT including suggested frequencies . 73
Table F.2 – Summary of RADIATION output tests for CBCT including suggested
frequency. . 77
Table J.1 – Overview of relevant ACCEPTANCE TESTS related to system changes . 89
– 8 – IEC 61223-3-8:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
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IEC 61223-3-8 has been prepared by subcommittee 62B: Medical imaging equipment, software,
and systems, of IEC technical committee 62: Medical equipment, software, and systems. It is
an International Standard.
The text of this document is based on the following documents:
Draft Report on voting
62B/1347/FDIS 62B/1351/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
IEC 61223-3-8:2024 © IEC 2024 – 9 –
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
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Die Norm EN IEC 61223-3-8:2024 hat einen klar definierten Anwendungsbereich, der sich auf die Bewertung der Bildqualität und die damit verbundenen Qualitätskontrollparameter von Röntgengeräten für die Radiografie und Radioskopie konzentriert. Diese Norm richtet sich an Fachleute in medizinischen Bildgebungsabteilungen und stellt sicher, dass diese Geräte den Anforderungen der IEC 60601-2-54:2022 oder IEC 60601-2-43:2022 entsprechen. Dies ist besonders relevant, da die Norm die gesamte Bildgebungs-Kette abdeckt, von der Bildakquisition über die Bildverarbeitung bis hin zur Bildanzeige. Eine der Stärken dieser Norm ist die Betonung auf Akzeptanz- und Konstanzprüfungen, die für das Qualitätsmanagement in medizinischen Bildgebungsabteilungen unerlässlich sind. Diese Prüfungen sollten von der verantwortlichen Organisation durchgeführt werden, was die Verantwortung und die Leistungsanforderungen klar definiert. Die detaillierte Diskussion im Abschnitt A.2 zur Position dieser Tests im Lebenszyklus medizinischer radiologischer Geräte bietet wertvolle Einblicke, die für die praktische Umsetzung der Norm von Bedeutung sind. Die Methoden, die in dieser Norm enthalten sind, stützen sich hauptsächlich auf nicht-invasive Messungen, die mit geeigneten Prüfgeräten durchgeführt werden, und richten sich nach den Installationsanweisungen des Herstellers. Diese Vorgehensweise gewährleistet, dass die Qualität der Bildgebung von Anfang an optimiert wird. Darüber hinaus stellt die Norm sicher, dass die für die Qualitätskontrolle erforderlichen Informationen an die verantwortliche Organisation weitergegeben werden, was die Transparenz und Nachvollziehbarkeit im Qualitätsmanagement erhöht. Zusammenfassend lässt sich sagen, dass die EN IEC 61223-3-8:2024 essentielle Leitlinien und Rahmenbedingungen für die Bewertung und die routinemäßigen Prüfungen in medizinischen Bildabteilungen bietet. Die Norm unterstützt Hersteller dabei, umfassende Qualitätskontrollhandbücher zu erstellen, was insbesondere im Annex G behandelt wird. Der klare Fokus auf Qualitätsmanagement und Leistungsbewertung bestimmt die Relevanz dieser Norm in einer zunehmend technologisierten und qualitätsbewussten medizinischen Umgebung.
The EN IEC 61223-3-8:2024 standard is a critical document that delineates the procedures for evaluating the imaging performance of X-ray equipment utilized in radiography and radioscopy, with a specific focus on acceptance and constancy tests. The standard specifically pertains to X-ray equipment that adheres to the requirements set forth in IEC 60601-2-54:2022 and IEC 60601-2-43:2022, thus ensuring that it meets necessary safety and performance criteria. One of the prominent strengths of this standard is its comprehensive scope, which encompasses the entire imaging chain-from image acquisition and processing to the final display. This holistic approach is essential for ensuring that all aspects of image quality are addressed, ultimately enhancing the diagnostic capabilities of medical imaging departments. The inclusion of non-invasive measurement methods further facilitates compliance, allowing for efficient testing without disrupting the operational functionality of the equipment. The document serves as a robust foundation for quality assurance programs, as it outlines the necessary acceptance and constancy tests that are vital to maintaining the reliability of X-ray systems over time. These tests are critical for validating that equipment continues to perform at optimal levels following installation, thereby safeguarding patient safety and ensuring high-quality imaging results. Additionally, the standard provides essential guidance for manufacturers regarding the formulation of a quality control manual, which is crucial for the responsible organization tasked with conducting these evaluations. The incorporation of detailed instructions in Annex G allows for clarity and consistency in the implementation of these tests, thereby promoting best practices across the medical imaging landscape. In summary, EN IEC 61223-3-8:2024 is highly relevant in today's medical imaging sector, ensuring that facilities can conduct accurate evaluations and tests of X-ray equipment performance, thereby contributing to enhanced patient outcomes and adherence to safety protocols within healthcare environments.
SIST EN IEC 61223-3-8:2024は、放射線撮影およびテレビ放射線技術におけるX線機器の映像性能評価と日常試験に関する重要な標準化文書です。この標準は、IEC 60601-2-54:2022またはIEC 60601-2-43:2022に準拠したX線機器の映像性能と関連する品質管理パラメータの評価に適用されます。 この標準の強みは、X線機器の映像性能を評価するための包括的なフレームワークを提供する点にあります。具体的には、画像取得、画像処理、画像表示に至るまでの一連のプロセス全体にわたる評価を含んでおり、医療画像部門での品質保証プログラムの一環として受入試験と恒常性試験を実施するための指針を提供しています。これにより、医療機関は高品質な画像を確保し、診断精度を向上させることができます。 また、標準には非侵襲的な測定法に基づく試験方法が含まれており、適切な試験機器を使用して製造者の設置指示に従ってインストール後に実施されます。これにより、X線機器が正常に機能しているかどうかを確認するための信頼性の高い手段が確保されています。 さらに、IEC 60601-2-54:2022およびIEC 60601-2-43:2022に基づき、品質管理に関する情報の提供が求められており、この文書は製造者に対してX線機器に関する受入試験および恒常性試験の推奨を含む品質管理マニュアルを作成する際の指針も示しています。附属書Gは、そのようなマニュアルに関する具体的なガイダンスを提供しています。 このように、SIST EN IEC 61223-3-8:2024は、医療画像の分野において高い relevancy を持ち、医療提供者が機器の性能を適切に把握し、持続的な品質管理を実施するために必要不可欠な基盤を構築しています。
Le document SIST EN IEC 61223-3-8:2024 propose une approche rigoureuse pour l'évaluation et les tests de routine des performances d'imagerie des équipements à rayons X utilisés en radiographie et radioscopie. Son champ d'application est clairement défini et s'applique à la performance d'imagerie ainsi qu'aux paramètres de contrôle qualité associés aux équipements à rayons X conformes aux normes IEC 60601-2-54:2022 et IEC 60601-2-43:2022. L'une des forces majeures de cette norme réside dans son attention portée à l'ensemble de la chaîne d'imagerie, englobant l'acquisition des images, leur traitement et leur affichage. Cela garantit une évaluation exhaustive et intégrée de l'équipement, ce qui est essentiel pour maintenir des standards élevés de qualité dans les départements d'imagerie médicale. De plus, le document se concentre sur les tests d'acceptation et les tests de constance, qui jouent un rôle crucial dans les programmes d'assurance qualité. La responsabilité de ces tests est clairement attribuée à l'organisation concernée, ce qui renforce la clarté des responsabilités et facilite la mise en œuvre efficace des procédures de contrôle qualité. Les méthodes proposées reposent principalement sur des mesures non invasives, ce qui est un avantage non négligeable, car cela réduit tout risque pour les patients et le personnel. Ces mesures sont effectuées après l'installation, conformément aux instructions du fabricant, garantissant ainsi la fiabilité des résultats obtenus. La norme fournit également des orientations précieuses aux fabricants concernant les tests d'acceptation et de constance, au sein d'un manuel de contrôle qualité fourni par le fabricant. Cela facilite la compréhension et l'application des exigences tout en soutenant la conformité avec les normes en vigueur. Enfin, l'annexe G, qui offre des conseils pour l'élaboration d'un manuel de contrôle qualité, renforce encore la pertinence de ce document en fournissant des ressources pratiques qui permettent aux organisations de mieux structurer et documenter leur approche en matière de contrôle qualité des équipements à rayons X. En somme, le SIST EN IEC 61223-3-8:2024 s'affirme comme une référence indispensable pour les départements d'imagerie médicale, apportant une cadre solide pour l'évaluation et le contrôle de la performance des équipements d'imagerie à rayons X.
표준 EN IEC 61223-3-8:2024는 방사선 촬영 및 방사선 관찰을 위한 X-선 장비의 이미징 성능 평가 및 관련 품질 관리 매개변수를 다루고 있습니다. 이 표준은 IEC 60601-2-54:2022 또는 IEC 60601-2-43:2022에 적합한 장비에 대해 적용됩니다. 이 문서는 이미지 획득, 이미지 처리 및 이미지 디스플레이에 이르는 전체 이미징 체인에 대한 평가를 포함합니다. 수용 테스트와 지속성 테스트는 의료 이미징 부서의 품질 보증 프로그램의 기본 요소로, 책임 있는 조직이 수행하거나 책임을 질 수 있도록 설계되었습니다. 특히, 이 표준은 이러한 테스트의 의료 방사선 장비 생애 주기 내에서의 위치에 대한 상세한 논의를 제시하고 있어 종합적인 접근 방식을 제공합니다. 제공된 방법들은 주로 비침습적 측정을 기반으로 하며, 적절한 테스트 장비를 사용하여 설치가 완료된 후 제조업체의 설치 지침에 따라 수행됩니다. IEC 60601-2-54:2022 및 IEC 60601-2-43:2022는 품질 관리와 관련하여 책임 있는 조직에 정보를 제공할 것을 요구합니다. 이에 따라, 본 표준은 제조업체에게 X-선 장비의 수용 테스트 및 지속성 테스트에 대한 지침을 제공하며, 제조업체의 품질 관리 매뉴얼에 대한 안내도 포함되어 있습니다. 부록 G는 이러한 매뉴얼을 위한 지침을 제공합니다. EN IEC 61223-3-8:2024는 방사선 이미징 부서에서 품질 보증을 위한 실질적인 방법론을 제시하여 의료 분야의 표준화에 기여하고 있으며, X-선 장비의 성능 향상 및 환자 안전성을 높이는 데 중요한 역할을 하고 있습니다. 이는 의료 이미징의 신뢰성과 효율성을 보장하는 데 필수적입니다.
記事タイトル：prEN IEC 61223-3-8:2022 - 医療画像診断科における評価と定期的なテスト - 第3-8部：受け入れおよび一定性試験 - レントゲン撮影およびラジオスコピーのためのX線機器の画像性能 この記事では、prEN IEC 61223-3-8:2022規格について説明しています。この規格は、医療画像診断科における評価と定期的なテストを対象としています。具体的には、レントゲン撮影およびラジオスコピーに使用されるX線機器の受け入れおよび一定性テストに関連しています。この規格は、医療環境におけるX線機器の品質と信頼性を確保することを目的としています。
The article discusses the prEN IEC 61223-3-8:2022 standard, which focuses on evaluation and routine testing in medical imaging departments. Specifically, it pertains to acceptance and constancy tests for the imaging performance of X-ray equipment used in radiography and radioscopy. The standard aims to ensure the quality and reliability of X-ray equipment in medical settings.
기사 제목: prEN IEC 61223-3-8:2022 - 의료 영상학 부서에서의 평가 및 일상 테스트 - 제 3-8 부: 수용 및 일정성 테스트 - 방사선 촬영 및 방송용 X-선 장비의 영상 퍼포먼스 기사는 prEN IEC 61223-3-8:2022 표준에 대해 논의하고 있다. 이 표준은 의료 영상학 부서에서의 평가 및 일상 테스트에 초점을 맞추고 있다. 특히, 방사선 촬영 및 방송용 X-선 장비의 영상 퍼포먼스에 대한 수용 및 일정성 테스트에 관한 것이다. 이 표준은 의료 환경에서 X-선 장비의 품질과 신뢰성을 보장하기 위해 제정되었다.
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