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
Current Stage
6060 - Document made available
Due Date
12-Jun-2015
Completion Date
12-Jun-2015

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SLOVENSKI STANDARD
SIST EN 62220-1-1:2015
01-september-2015
1DGRPHãþD
SIST EN 62220-1:2004
0HGLFLQVNDHOHNWULþQDRSUHPD.DUDNWHULVWLNHGLJLWDOQLKQDSUDY]DUHQWJHQVNR

VOLNDQMHGHO8JRWDYOMDQMHNYDQWQHJDL]NRULVWND]D]QDYDQMD'HWHNWRUML]D

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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
SIST EN 62220-1-1:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 62220-1-1:2015
---------------------- Page: 2 ----------------------
SIST EN 62220-1-1:2015
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
---------------------- Page: 3 ----------------------
SIST EN 62220-1-1:2015
EN 62220-1-1:2015
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.
---------------------- Page: 4 ----------------------
SIST EN 62220-1-1:2015
EN 62220-1-1:2015
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
---------------------- Page: 5 ----------------------
SIST EN 62220-1-1:2015
EN 62220-1-1:2015
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.
---------------------- Page: 6 ----------------------
SIST EN 62220-1-1:2015
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 62220-1-1:2015
– 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

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SIST EN 62220-1-1:2015
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 ........................................................................................ 18

Table 3 – Parameters mandatory for the application of this standard .................................... 20

---------------------- Page: 9 ----------------------
SIST EN 62220-1-1:2015
– 4 – IEC 62220-1-1:2015 © IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES –
Part 1-1: Determination of the detective quantum efficiency –
Detectors used in 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 may participate in this preparatory work. International, governmental and non-

governmental organizations liaising 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.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 62220-1-1 has been prepared by subcommittee 62B: Diagnostic

imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.

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 SNR ;
– 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);
---------------------- Page: 10 ----------------------
SIST EN 62220-1-1:2015
IEC 62220-1-1:2015 © IEC 2015 – 5 –

– a description of (optionally) obtaining the diagonal (45°) MTF and NPS has been added.

The text of this standard is based on the following documents:
FDIS Report on voting
62B/968/FDIS 62B/974/RVD

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 62220 series, published under the general title Medical electrical

equipment – Characteristics of digital X-ray imaging devices, can be found on the IEC

website.

In this standard, terms printed in SMALL CAPITALS are used as defined in IEC 60788, in Clause

3 of this standard or in other IEC publications referenced in the Index of defined terms. Where

a defined term is used as a qualifier in another defined or undefined term, it is not printed in

SMALL CAPITALS, unless the concept thus qualified is defined or recognized as a “derived term

without definition”.

NOTE Attention is drawn to the fact that, in cases where the concept addressed is not strongly confined to the

definition given in one of the publications listed above, a corresponding term is printed in lower-case letters.

In this standard, certain terms that are not printed in SMALL CAPITALS have particular

meanings, as follows:
– "shall" indicates a requirement that is mandatory for compliance;

– "should" indicates a strong recommendation that is not mandatory for compliance;

– "may" indicates a permitted manner of complying with a requirement or of avoiding the

need to comply;

– "specific" is used to indicate definitive information stated in this standard or referenced in

other standards, usually concerning particular operating conditions, test arrangements or

values connected with compliance;

– "specified" is used to indicate definitive information stated by the manufacturer in

accompanying documents or in other documentation relating to the equipment under

consideration, usually concerning its intended purposes, or the parameters or conditions

associated with its use or with testing to determine compliance.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 11 ----------------------
SIST EN 62220-1-1:2015
– 6 – IEC 62220-1-1:2015 © IEC 2015
INTRODUCTION

DIGITAL X-RAY IMAGING DEVICES are increasingly used in medical diagnosis and are widely

replacing conventional (analogue) imaging devices such as screen-film systems or analogue

X-RAY IMAGE INTENSIFIER television systems. It is necessary, therefore, to define parameters

that describe the specific imaging properties of these DIGITAL X-RAY IMAGING DEVICES and to

standardize the measurement procedures employed.

There is general consensus in the scientific world that the DETECTIVE QUANTUM EFFICIENCY

(DQE) is the most suitable parameter for describing the imaging performance of a DIGITAL X-

RAY IMAGING DEVICE. The DQE describes the ability of the imaging device to preserve the

signal-to-noise ratio from the RADIATION FIELD to the resulting digital image data. Since in X-

ray imaging, the NOISE in the RADIATION FIELD is intimately coupled to the AIR KERMA level, DQE

values can also be considered to describe the dose efficiency of a given DIGITAL X-RAY

IMAGING DEVICE.

NOTE 1 In spite of the fact that the DQE is widely used to describe the performance of imaging devices, the

connection between this physical parameter and the decision performance of a human observer is not yet

completely understood [1], [3].

NOTE 2 IEC 61262-5 specifies a method to determine the DQE of X-RAY IMAGE INTENSIFIERS at nearly zero

SPATIAL FREQUENCY. It focuses only on the electro-optical components of X-RAY IMAGE INTENSIFIERS, not on the

imaging properties as this standard does. As a consequence, the output is measured as an optical quantity

(luminance), and not as digital data. Moreover, IEC 61262-5 prescribes the use of a RADIATION SOURCE ASSEMBLY,

whereas this standard prescribes the use of an X-RAY TUBE. The scope of IEC 61262-5 is limited to X-RAY IMAGE

INTENSIFIERS and does not interfere with the scope of this standard.

The DQE is already widely used by manufacturers to describe the performance of their DIGITAL

X-RAY IMAGING DEVICE. The specification of the DQE is also required by regulatory agencies

(such as the Food and Drug Administration (FDA)) for admission procedures. However, before

the publication of the first edition of this standard there was no standard governing either the

measurement conditions or the measurement procedure, with the consequence that values

from different sources may not be comparable.

This standard has therefore been developed in order to specify the measurement procedure

together with the format of the conformance statement for the DETECTIVE QUANTUM EFFICIENCY

of DIGITAL X-RAY IMAGING DEVICES.

In the DQE calculations proposed in this standard, it is assumed that system response is

measured for objects that attenuate all energies equally (task-independent) [5].

This standard will be beneficial for manufacturers, users, distributors and regulatory agencies.

This first edition of IEC 62220-1-1 forms part of a series of three related standards:

• Part 1-1, which is intended to be used for detectors used in radiographic imaging,

excluding MAMMOGRAPHY and RADIOSCOPY;
• Part 1-2, which is intended to be used for detectors used in MAMMOGRAPHY;
• Part 1-3, which is intended to be used for detectors used in dynamic imaging.
———————
Figures in square brackets refer to the bibliography.
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SIST EN 62220-1-1:2015
IEC 62220-1-1:2015 © IEC 2015 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES –
Part 1-1: Determination of the detective quantum efficiency –
Detectors used in radiographic imaging
1 Scope

This part of IEC 62220 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.

NOTE 1 While not recommended, applying this standard to determine the DQE of digital X-ray imaging devices

integrated in a clinical system is not excluded as long as the requirements as set in this standard are respected.

Points of additional attention could be (for example but not exclusively) the establishment of the required RADIATION

QUALITIES, minimizing influences of scattered and back-scattered radiation, accurate AIR KERMA measurements,

positioning of the TEST DEVICE, presence of protective covers, removal of ANTI-SCATTER GRID.

This Part 1-1 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for radiographic

imaging such as, but not exclusively, CR systems, direct and indirect flat panel-detector

based systems.

It is not recommended to use this part of IEC 62220 for digital X-RAY IMAGE INTENSIFIER-based

systems.

NOTE 2 The use of this standard for X-RAY IMAGE INTENSIFER-based systems is discouraged based on the low

frequency drop, vignetting and geometrical distortion present in these devices which may put severe limitations on

the applicability of the measurement methods described in this standard.
This part of IEC 62220 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;

– devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac

imaging).

NOTE 3 The devices noted above are excluded because they contain many parameters (for instance, beam

qualities, geometry, time dependence, etc.) which differ from those important for RADIOGRAPHY. Some of these

techniques are treated in other parts of the IEC 62220 standards (IEC 62220-1-2 and IEC 62220-1-3).

2 Normative references

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.

IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –

Characteristics of focal spots
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
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SIST EN 62220-1-1:2015
– 8 – IEC 62220-1-1:2015 © IEC 2015

IEC 61267:2005, Medical diagnostic X-ray equipment – Radiation conditions for use in the

determination of characteristics
3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60788:2004 and the

following apply.
3.1
CALIBRATION CONDITIONS
set of conditions under which calibration is done
3.2
CENTRAL AXIS

line perpendicular to the ENTRANCE PLANE passing through the centre of the ENTRANCE FIELD

3.3
CONVERSION FUNCTION

plot of the large area output level (ORIGINAL DATA) of a DIGITAL X-RAY IMAGING DEVICE versus

the number of exposure quanta per unit area (Q) in the DETECTOR SURFACE plane

Note 1 to entry: Q is to be calculated by multiplying the measured AIR KERMA excluding back scatter by the value

given in column 2 of Table 3.
3.4
DETECTIVE QUANTUM EFFICIENCY
DQE
DQE(u,v)

ratio of two NOISE POWER SPECTRUM (NPS) functions with the numerator being the NPS of the

DETECTOR SURFACE of a digital X-ray detector after having gone through the
input signal at the

deterministic filter given by the system transfer function, and the denominator being the

measured NPS of the output signal (ORIGINAL DATA)
Note 1 to entry: Instead of the two-dimensional D
...

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