EN 62220-1-1:2015

Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging

IEC 62220-1-1:2015 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories. This first edition of IEC 62220-1-1 cancels and replaces IEC 62220-1:2003. It constitutes a technical revision of IEC 62220-1:2003 and assures a better alignment with the other parts of the IEC 62220 series. The main changes are as follows: - necessary modifications have been applied as a consequence of taking into account IEC 61267:2005. This influences HVL values and SNRin2; - the method for the determination of LAG EFFECTS now considers lag and ghosting compensation; - as part of the MTF determination, the method of obtaining the final averaged MTF has been restricted (only averaging of the ESF is allowed); - a description of (optionally) obtaining the diagonal (45°) MTF and NPS has been added.

Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-1: Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung

Appareils électromédicaux - Caractéristiques des dispositifs d’imagerie à rayonnements x - Partie 1-1: Détermination de l'efficacité quantique de détection - Détecteurs utilisés en imagerie radiographique

L'IEC 62220-1-1:2015 spécifie la méthode de détermination de l'EFFICACITE QUANTIQUE DE DETECTION (EQD) des DISPOSITIFS D'IMAGERIE NUMERIQUE A RAYONNEMENT X en tant qu'une fonction du KERMA DANS L'AIR et de la FREQUENCE SPATIALE pour les conditions de fonctionnement dans la gamme des applications médicales, telles que spécifiées par le FABRICANT. Les utilisateurs prévus de la présente partie de l'IEC 62220 sont les fabricants et les laboratoires d'essai bien équipés. La présente Partie 1-1 est limitée aux DISPOSITIFS D'IMAGERIE NUMERIQUE A RAYONNEMENT X qui sont utilisés dans l'imagerie radiographique, tels que, mais pas exclusivement, les systèmes CR et les systèmes à base de détecteur à panneau plat direct ou indirect. Cette première édition de l'IEC 62220-1-1 annule et remplace l'IEC 62220-1:2003. Cette édition constitue une révision technique de l'IEC 62220-1:2003 et assure un meilleur alignement avec les autres parties de la série IEC 62220. Les changements majeurs sont les suivants: - l'application des modifications nécessaires suite à la prise en compte de l'IEC 61267:2005. Cela influence les valeurs de HVL et SNRin2; - la prise en compte de la compensation de rémanence ou d'images fantômes dans la méthode pour la détermination des EFFETS DE REMANENCE; - la limitation de la méthode d'obtention de la MTF moyenne finale dans le cadre de la détermination de la MTF (seul l'établissement de la moyenne de l'ESF est autorisé); - l'ajout d une description de l'obtention (facultative) de la MTF diagonale (45 degrés) et du NPS.

Medicinska električna oprema - Karakteristike digitalnih naprav za rentgensko slikanje - 1-1. del: Ugotavljanje kvantnega izkoristka zaznavanja - Detektorji za rentgensko slikanje

Ta del standarda IEC 62220 določa metodo za ugotavljanje KVANTNEGA IZKORISTKA ZAZNAVANJA (DQE) DIGITALNIH NAPRAV ZA RENTGENSKO SLIKANJE kot funkcije KERME V ZRAKU in PROSTORSKE FREKVENCE za delovne pogoje v razponu medicinske uporabe, kot jo določi PROIZVAJALEC. Predvideni uporabniki tega dela standarda IEC 62220 so proizvajalci in dobro opremljeni preskusni laboratoriji.
OPOMBA 1: Čeprav to ni priporočljivo, uporaba tega standarda za ugotavljanje DQE digitalnih naprav za rentgensko slikanje, vgrajenih v klinični sistem, ni izključena, dokler se upoštevajo zahteve iz tega standarda.
Dodatno bi bili lahko pozorni na (na primer, vendar ne le na to) določitev zahtevanih LASTNOSTI SEVANJA, zmanjšanje vplivov razpršenega in odbitega razpršenega sevanja, točne meritve KERME V ZRAKU, določanje položaja PRESKUSNE NAPRAVE, prisotnost zaščitnih pokrovov, odstranitev PROTIRAZPRŠILNE MREŽICE. 1-1. del je omejen na DIGITALNE NAPRAVE ZA RENTGENSKO SLIKANJE, ki se uporabljajo za radiografsko slikanje, kot so (vendar ne izključno) sistemi za računalniško digitalno radiografijo (CR), neposredni in posredni sistemi na podlagi ploščatih detektorjev.
Tega dela standarda IEC 62220 ni priporočljivo uporabljati za digitalne sisteme na podlagi OJAČEVALCEV RENTGENSKE SLIKE.
OPOMBA 2: Uporaba tega standarda za sisteme na podlagi OJAČEVALCEV RENTGENSKE SLIKE ni priporočljiva zaradi nizkofrekvenčnega upada, vinjetiranja in geometrijskega popačenja, prisotnega v teh napravah, kar lahko zelo omeji uporabnost merilnih metod, opisanih v tem standardu.
Ta del standarda IEC 62220 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,
– naprave za dinamično slikanje (pri čemer se pridobijo serije slik, kot pri fluoroskopiji ali slikanju srca).
OPOMBA 3: Navedene naprave so izključene, ker vključujejo veliko parametrov (na primer lastnosti žarka, geometrijo, časovno odvisnost itd.), ki se razlikujejo od parametrov, pomembnih za RADIOGRAFIJO. Nekatere od teh tehnik so opisane v drugih delih standardov IEC 62220 (IEC 62220-1-2 in IEC 62220-1-3).

General Information

• Status: Published
• Publication Date: 11-Jun-2015
• Withdrawal Date: 15-Apr-2018
• 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: 12-Jun-2015
• Completion Date: 12-Jun-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 62220-1-1:2015 - Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging

Relations

• Replaces: EN 62220-1:2004 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 62220-1:2004
0HGLFLQVNDHOHNWULþQDRSUHPD.DUDNWHULVWLNHGLJLWDOQLKQDSUDY]DUHQWJHQVNR
VOLNDQMHGHO8JRWDYOMDQMHNYDQWQHJDL]NRULVWND]D]QDYDQMD'HWHNWRUML]D
UHQWJHQVNRVOLNDQMH
Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1:
Determination of the detective quantum efficiency - Detectors used in radiographic
imaging
Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-1:
Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung
Appareils électromédicaux - Caractéristiques des appareils d’imagerie à rayonnements x
- Partie 1-1: Détermination de l'efficacité quantique de détection - Détecteurs utilisés en
imagerie radiographique
Ta slovenski standard je istoveten z: EN 62220-1-1:2015
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 62220-1-1

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.50 Supersedes EN 62220-1:2004
English Version
Medical electrical equipment - Characteristics of digital x-ray
imaging devices - Part 1-1: Determination of the detective
quantum efficiency - Detectors used in radiographic imaging
(IEC 62220-1-1:2015)
Appareils électromédicaux - Caractéristiques des appareils Medizinische elektrische Geräte - Merkmale digitaler
d'imagerie à rayonnements x - Partie 1-1: Détermination de Röntgenbildgeräte - Teil 1-1: Bestimmung der detektiven
l'efficacité quantique de détection - Détecteurs utilisés en Quanten-Ausbeute - Bildempfänger für Röntgenbildgebung
imagerie radiographique (IEC 62220-1-1:2015)
(IEC 62220-1-1:2015)
This European Standard was approved by CENELEC on 2015-04-16. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62220-1-1:2015 E
Foreword
The text of document 62B/968/FDIS, future edition 2 of IEC 62220-1-1, 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 62220-1-1:2015.
The following dates are fixed:
(dop) 2016-01-16
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-16
standards conflicting with the
document have to be withdrawn
This document supersedes EN 62220-1:2004.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 62220-1-1:2015 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 standards indicated:
IEC 62220-1-3:2008 NOTE Harmonized as EN 62220-1-3:2008.
IEC 62220-1-2:2007 NOTE Harmonized as EN 62220-1-2:2007.
IEC 61262-5:1994 NOTE Harmonized as EN 61262-5:1994.
IEC 60601-2-54 NOTE Harmonized as EN 60601-2-54.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.cenelec.eu.
Publication Year Title EN/HD Year

IEC 60336 -  Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EC Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives can be applied to the products falling within
the scope of this standard.
IEC 62220-1-1 ®
Edition 1.0 2015-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Characteristics of digital X-ray imaging devices –

Part 1-1: Determination of the detective quantum efficiency – Detectors used in

radiographic imaging
Appareils électromédicaux – Caractéristiques des dispositifs d’imagerie à

rayonnement X –
Partie 1-1: Détermination de l'efficacité quantique de détection – Détecteurs

utilisés en imagerie radiographique

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2389-5

– 2 – IEC 62220-1-1:2015 © IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements . 10
4.1 Operating conditions . 10
4.2 X-RAY EQUIPMENT . 10
4.3 RADIATION QUALITY . 10
4.4 TEST DEVICE . 11
4.5 Geometry . 12
4.6 IRRADIATION conditions . 14
4.6.1 General conditions . 14
4.6.2 AIR KERMA measurement . 15
4.6.3 Avoidance of LAG EFFECTS . 16
4.6.4 IRRADIATION to obtain the CONVERSION FUNCTION. 16
4.6.5 IRRADIATION for determination of the NOISE POWER SPECTRUM . 16
4.6.6 IRRADIATION for determination of the MODULATION TRANSFER FUNCTION . 17
4.6.7 Overview of all necessary IRRADIATIONS . 18
5 Corrections of RAW DATA . 18
6 Determination of the DETECTIVE QUANTUM EFFICIENCY. 19
6.1 Definition and formula of DQE(u,v) . 19
6.2 Parameters to be used for evaluation . 19
6.3 Determination of different parameters from the images . 20
6.3.1 Linearization of data . 20
6.3.2 The NOISE POWER SPECTRUM (NPS) . 20
6.3.3 Determination of the MODULATION TRANSFER FUNCTION (MTF) . 22
7 Format of conformance statement . 24
8 Accuracy . 25
Annex A (normative) Determination of LAG EFFECTS . 26
A.1 Overview. 26
A.2 Estimation of LAG EFFECTS (default method) . 26
A.3 Estimation of LAG EFFECTS, alternative method (only if no LAG EFFECT or
ghosting compensation is applied) . 26
A.3.1 General . 26
A.3.2 Test of additive LAG EFFECTS . 27
A.3.3 Test of multiplicative LAG EFFECTS . 29
A.3.4 Determination of the minimum time between consecutive images . 31
Annex B (informative) Calculation of the input NOISE POWER SPECTRUM. 32
Bibliography . 33
Index of defined terms used in this particular standard . 36

Figure 1 – TEST DEVICE for the determination of the MODULATION TRANSFER FUNCTION
and the magnitude of LAG EFFECTS . 12

IEC 62220-1-1:2015 © IEC 2015 – 3 –
Figure 2 – Geometry for exposing the DIGITAL X-RAY IMAGING DEVICE behind the TEST
DEVICE in order to determine LAG EFFECTS and the MODULATION TRANSFER FUNCTION . 14
Figure 3 – Position of the TEST DEVICE for the determination of the MODULATION
TRANSFER FUNCTION . 17
Figure 4 – Geometric arrangement of the ROIs for NPS calculation . 21
Figure 5 – Representation of the image acquired for the determination of the MTF . 23
Figure A.1 – Definition of the ROIs for the test of additive LAG EFFECTS . 28
Figure A.2 – Procedure flow diagram for the test of additive LAG EFFECTS . 28
Figure A.3 – Definition of the ROIs for the test of the multiplicative LAG EFFECTS . 30
Figure A.4 – Procedure flow diagram for the test of multiplicative LAG EFFECTS . 30

Table 1 – RADIATION QUALITY (IEC 61267:2005) for the determination of DETECTIVE
QUANTUM EFFICIENCY and corresponding parameters . 11
Table 2 – Necessary IRRADIATIONS .
...