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IEC 62220-2-1:2023

(Main)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging

IEC 62220-2-1:2023 describes the performance metrics associated with DUAL-ENERGY IMAGING capable DIGITAL X-RAY IMAGING DEVICES meant for medical applications and specifies the methods for their determination. These metrics can be used to analyse TISSUE-SUBTRACTED IMAGES and to evaluate dose performance, noise characteristics, and tissue-subtraction efficacy of DIGITAL X-RAY IMAGING DEVICES. The described methods indicate the procedures to obtain MULTI-SPECTRAL PRIMARY DATA and to compute their derived TISSUE-SUBTRACTED IMAGES.
The intended users of this document are MANUFACTURERS and well-equipped test laboratories. This document is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems.
This document excludes and is not applicable to:
– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental RADIOGRAPHY;
– slot scanning DIGITAL X-RAY IMAGING DEVICES;
– COMPUTED TOMOGRAPHY or CONE-BEAM COMPUTED TOMOGRAPHY;
– photon-energy discriminating devices such as photon counting X-RAY IMAGING DEVICES;
– devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac imaging).
– DIGITAL X-RAY IMAGING DEVICES intended to be used with RADIOTHERAPY beams.

Appareils électromédicaux - Caractéristiques des dispositifs d’imagerie à rayonnement X - Partie 2-1: Détermination de l’efficacité de soustraction à double énergie - Détecteurs utilisés en imagerie radiographique à double énergie

L'IEC 62220-2-1:2023 décrit les mesures normalisées de performances associées aux DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X capables d’IMAGERIE A DOUBLE ENERGIE destinés à des applications médicales, et spécifie leur méthode de détermination. Ces mesures normalisées peuvent être utilisées pour analyser les IMAGES SOUSTRAITES DES TISSUS et pour évaluer les performances liées à la dose, les caractéristiques sonores et les performances de soustraction des tissus des DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X. Les méthodes décrites indiquent les procédures permettant d’obtenir des DONNEES PRIMAIRES MULTISPECTRALES et de calculer les IMAGES SOUSTRAITES DES TISSUS qui leur sont dérivées.
Les utilisateurs prévus du présent document sont les FABRICANTS et les laboratoires d'essai aux équipements modernes. Le présent document est limité aux DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X qui sont utilisés dans l’imagerie radiographique à double énergie à exposition unique ou multiple fondés, par exemple, sur les systèmes CR et les systèmes à base de détecteur à panneau plat direct ou indirect.
Le présent document exclut et ne s’applique pas:
– aux DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X destinés à être utilisés en mammographie ou en RADIOGRAPHIE dentaire;
– aux DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X à balayage de fente;
– à la TOMODENSITOMETRIE ou à la TOMODENSITOMETRIE A FAISCEAU CONIQUE;
– aux dispositifs de discrimination en énergie de photon, tels que les DISPOSITIFS D’IMAGERIE A RAYONNEMENT X à comptage de photon;
– aux dispositifs d’imagerie dynamique (où des ensembles d’images sont acquis, comme en radioscopie ou en imagerie cardiaque).
– aux DISPOSITIFS D’IMAGERIE NUMERIQUE A RAYONNEMENT X destinés à être utilisés avec des faisceaux de RADIOTHERAPIE.

General Information

Status
Published
Publication Date
08-Aug-2023
ICS
11.040.50 - Radiographic equipment
Technical Committee
SC 62B - Medical imaging equipment, software, and systems
Drafting Committee
WG 44 - TC 62/SC 62B/WG 44
Current Stage
PPUB - Publication issued
Start Date
30-Aug-2023
Completion Date
09-Aug-2023
Ref Project

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IEC 62220-2-1:2023 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging Released:8/9/2023IEC 62220-2-1:2023 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging Released:8/9/2023
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IEC 62220-2-1:2023 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging Released:8/9/2023
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IEC 62220-2-1 ®
Edition 1.0 2023-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Characteristics of digital X-ray imaging devices –
Part 2-1: Determination of dual-energy subtraction efficiency – Detectors used
for dual-energy radiographic imaging

Appareils électromédicaux – Caractéristiques des dispositifs d’imagerie à
rayonnement X –
Partie 2-1: Détermination de l’efficacité de soustraction à double énergie –
Détecteurs utilisés en imagerie radiographique à double énergie
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IEC 62220-2-1 ®
Edition 1.0 2023-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Characteristics of digital X-ray imaging devices –

Part 2-1: Determination of dual-energy subtraction efficiency – Detectors used

for dual-energy radiographic imaging

Appareils électromédicaux – Caractéristiques des dispositifs d’imagerie à

rayonnement X –
Partie 2-1: Détermination de l’efficacité de soustraction à double énergie –

Détecteurs utilisés en imagerie radiographique à double énergie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50  ISBN 978-2-8322-7305-0

– 2 – IEC 62220-2-1:2023 © IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 7
4.1 Operating conditions . 7
4.2 X-RAY EQUIPMENT . 7
4.3 RADIATION QUALITY . 8
4.4 TEST DEVICE . 8
4.5 Geometry . 9
4.6 IRRADIATION conditions . 9
4.6.1 General conditions . 9
4.6.2 IRRADIATION for the determination of the dual-energy contrast . 10
4.6.3 AIR KERMA measurement . 10
5 Corrections of RAW DATA . 10
6 Definitions of the REGIONS OF INTEREST . 11
7 Calculation of derived images . 11
7.1 Calculation of high-energy and low-energy images . 11
7.2 Calculation of TISSUE-SUBTRACTED IMAGES . 12
8 Determination of the dual-energy subtraction efficiency . 13
8.1 Definition and formula of the DSE . 13
8.2 Determination of the dual-energy contrast . 13
9 Format of conformance statement . 14
Annex A (informative) Dual-energy subtraction efficiency interpretation . 15
A.1 Metric description . 15
A.2 Sample device comparisons . 16
Bibliography . 19
Index of defined terms used in this particular standard . 20

Figure 1 – TEST DEVICE for the determination of the dual-energy contrast . 8
Figure 2 – Geometry for all IRRADIATIONS of the TEST DEVICE . 9
Figure 3 – Feature and background REGIONS OF INTEREST defined about circular image
of features . 11
Figure A.1 – Sample DSE results for a simulated MULTI-EXPOSURE DEVICE . 15
s
Figure A.2 – Sample DSE results for a simulated MULTI-EXPOSURE DEVICE at
s
increasing SCINTILLATOR thickness . 17
Figure A.3 – Sample results for a simulated MULTI-EXPOSURE DEVICE at differing
DSE
s
X‑RAY TUBE VOLTAGE used for their high-energy IRRADIATIONS . 17
Figure A.4 – Sample DSE results for a simulated MULTI-EXPOSURE DEVICES at
s
increasing PIXEL pitch . 18

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES –

Part 2-1: Determination of dual-energy subtraction efficiency –
Detectors used for dual-energy radiographic imaging

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
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with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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...

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DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply.
The object of this document is to establish:
- the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning;
- methods of testing and whether measured quantities related to those parameters comply with the specified requirements.
These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.

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