EN 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

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.

Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 2-1: Bestimmung des Wirkungsgrades der Zwei-Energie-Subtraktion - Detektoren für die Zwei-Energie-Röntgenbildgebung

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.

Medicinska električna oprema - Karakteristike digitalnih naprav za rentgensko slikanje - 2-1. del: Ugotavljanje učinkovitosti dvoenergijskega odštevanja - Detektorji, ki se uporabljajo pri radiografskem slikanju z dvojno energijo (IEC 62220-2-1:2023)

Standard IEC 62220-2-1:2023 opisuje meritev zmogljivosti v zvezi z RADIOGRAFSKIM SLIKANJEM Z DVOJNO ENERGIJO z DIGITALNIMI NAPRAVAMI ZA RENTGENSKO SLIKANJE, ki so namenjene medicinski uporabi, in podaja metode za njihovo določanje. To meritev je mogoče uporabiti za analiziranje SLIK ODŠTETEGA TKIVA in ocenjevanje učinkov pri odmerjanju, značilnosti hrupa in učinkovitosti odštevanja tkiva DIGITALNIH NAPRAV ZA RENTGENSKO SLIKANJE. Opisane metode navajajo postopke za pridobivanje MULTISPEKTRALNIH PRIMARNIH PODATKOV in računanje njihovih izpeljanih SLIK ODŠTETEGA TKIVA.
Predvideni uporabniki tega dokumenta so PROIZVAJALCI in dobro opremljeni preskusni laboratoriji. Ta dokument je omejen na DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, ki se uporabljajo za enkratno ali večkratno izpostavljenost radiografskemu slikanju z dvojno energijo, na primer na podlagi sistemov za računalniško digitalno radiografijo (CR), neposrednih in posrednih sistemov na podlagi ploščatih detektorjev.
Dokument ne vključuje in se ne uporablja za:
– DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, namenjene uporabi v mamografiji ali dentalni RADIOGRAFIJI,
– DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, ki skenirajo reže,
– RAČUNALNIŠKO TOMOGRAFIJO ali RAČUNALNIŠKO TOMOGRAFIJO S STOŽČASTIM SNOPOM,
– naprave za ločevanje fotonske energije, npr. NAPRAVE ZA RENTGENSKO SLIKANJE s štetjem fotonov,
– naprave za dinamično slikanje (pri čemer se pridobijo serije slik, kot pri fluoroskopiji ali slikanju srca).
– DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, namenjene uporabi z RADIOTERAPEVTSKIMI žarki.

General Information

• Status: Published
• Publication Date: 14-Sep-2023
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 15-Sep-2023
• Due Date: 31-Dec-2022
• Completion Date: 15-Sep-2023
• Ref Project: SIST EN IEC 62220-2-1:2024 - 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)

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2024
Medicinska električna oprema - Karakteristike digitalnih naprav za rentgensko
slikanje - 2-1. del: Ugotavljanje učinkovitosti dvoenergijskega odštevanja -
Detektorji, ki se uporabljajo pri radiografskem slikanju z dvojno energijo (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 (IEC 62220-2-1:2023)
Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 2-1:
Bestimmung des Wirkungsgrades der Zwei-Energie-Subtraktion - Detektoren für die
Zwei-Energie-Röntgenbildgebung (IEC 62220-2-1:2023)
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 (IEC 62220-2-1:2023)
Ta slovenski standard je istoveten z: EN IEC 62220-2-1:2023
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 62220-2-1

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2023
ICS 11.040.50
English Version
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)
Appareils électromédicaux - Caractéristiques des dispositifs Medizinische elektrische Geräte - Merkmale digitaler
d'imagerie à rayonnement X - Partie 2-1: Détermination de Röntgenbildgeräte - Teil 2-1: Bestimmung des
l'efficacité de soustraction à double énergie - Détecteurs Wirkungsgrades der Zwei-Energie-Subtraktion - Detektoren
utilisés en imagerie radiographique à double énergie für die Zwei-Energie-Röntgenbildgebung
(IEC 62220-2-1:2023) (IEC 62220-2-1:2023)
This European Standard was approved by CENELEC on 2023-09-13. 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 62220-2-1:2023 E

European foreword
The text of document 62B/1288/CDV, future edition 1 of IEC 62220-2-1, 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 62220-2-1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-06-13
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-09-13
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 62220-2-1:2023 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 60601-2-54 NOTE Approved as EN 60601-2-54
IEC 60601-1-3:2008 NOTE Approved as EN 60601-1-3:2008 (not modified) + A11:2016
IEC 61674:2012 NOTE Approved as EN 61674:2013 (not modified)
IEC 62220-1-1:2015 NOTE Approved as EN 62220-1-1:2015 (not modified)
IEC 60601-2-68:2014 NOTE Approved as EN 60601-2-68:2015 (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 - Medical electrical equipment - X-ray tube EN IEC 60336 -
assemblies for medical diagnosis - Focal spot
dimensions and related characteristics
IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined - -
terms
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

IEC 62220-2-1:2023 © IEC 2023 – 3 –
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
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