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 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.

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.

General Information

• Status: Published
• Publication Date: 25-Mar-2024
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 37 - TC 62/SC 62B/WG 37
• Current Stage: PPUB - Publication issued
• Start Date: 26-Mar-2024
• Completion Date: 12-Apr-2024

Standards Content (Sample)

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
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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

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

– 4 – IEC 61223-3-8:2024 © IEC 2024
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

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

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

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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.
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/publications.
In this document, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type.
– explanations, advice, notes, general statements, exceptions and references: in smaller type.
– test specifications: in italic type.
– TERMS USED THROUGHOUT THIS DOCUMENT THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED
TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: IN SMALL CAPITALS.
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
A list of all parts of the IEC 61223 series, published under the general title Evaluation and
routine testing in medical imaging departments, can be found on the IEC website.
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, or
• revised.
NOTE The attention of the users of this document is drawn to the fact that equipment MANUFACTURERS and testing
organizations might need a transitional period following publication of a new, amended or revised IEC publication in
order to develop contractual specifications in accordance with the new test procedures and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

– 10 – IEC 61223-3-8:2024 © IEC 2024
INTRODUCTION
The IEC 61223 series gives methods for ACCEPTANCE TESTS and CONSTANCY TESTS for diagnostic
X‑RAY EQUIPMENT.
IEC 60601-2-54:2022 and IEC 60601-2-43:2022 state that the MANUFACTURER provides
ACCOMPANYING DOCUMENTS with instructions for MANUFACTURER-recommended QUALITY CONTROL
PROCEDURES and tests to be performed on the X‑RAY EQUIPMENT by the RESPONSIBLE
ORGANIZATION. In this document, these instructi
...