EN 62220-1-3:2008

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging

IEC 62220-1-3:2008 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 Part 1-3 is restricted to digital X-ray imaging devices that are used for dynamic imaging such as, but not exclusively, 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.

Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-3: Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für dynamische Bildgebung

Appareils électromédicaux - Caractéristiques des dispositifs d'imagerie numérique à rayonnement X - Partie 1-3: Détermination de l'efficacité quantique de détection - Détecteurs utilisés en imagerie dynamique

La CEI 62220-1-3:2008 spécifie la méthode de la détermination de l'efficacité quantique de détection (EQD) des dispositifs d'imagerie numérique à rayonnement X en fonction du kerma dans l'air et de la fréquence spatiale pour les conditions de fonctionnement dans la gamme des applications médicales, suivant les spécifications du fabricant. Les utilisateurs prévus de la présente partie de la CEI 62220 sont les fabricants et les laboratoires d'essai bien équipés.La présente partie 1-3 se limite aux dispositifs d'imagerie numérique à rayonnement X qui sont utilisés pour l'imagerie dynamique telle que, mais pas exclusivement, des systèmes à base de détecteurs plans direct ou indirect. Il n'est pas recommandé d'utiliser cette partie de la CEI 62220 pour des systèmes basés sur un intensificateur d'image radiologique.

Medicinska električna oprema - Karakteristike digitalnih naprav za rentgensko slikanje - 1-3. del: Ugotavljanje kvantne učinkovitosti odkrivanja - Detektorji pri dinamičnem slikanju (IEC 62220-1-3:2008)

General Information

• Status: Published
• Publication Date: 02-Sep-2008
• Withdrawal Date: 30-Jun-2011
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-Sep-2008
• Completion Date: 03-Sep-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning 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 62220-1-3:2008 - Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2008
0HGLFLQVNDHOHNWULþQDRSUHPD.DUDNWHULVWLNHGLJLWDOQLKQDSUDY]DUHQWJHQVNR
VOLNDQMHGHO8JRWDYOMDQMHNYDQWQHXþLQNRYLWRVWLRGNULYDQMD'HWHNWRUMLSUL
GLQDPLþQHPVOLNDQMX,(&
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3:
Determination of the detective quantum efficiency - Detectors used in dynamic imaging
(IEC 62220-1-3:2008)
Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-3:
Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für dynamische
Bildgebung (IEC 62220-1-3:2008)
Appareils électromédicaux - Caractéristiques des dispositifs d'imagerie numérique à
rayons X - Partie 1-3: Détermination de l'efficacité quantique de détection - Détecteurs
utilisés en imagerie dynamique (CEI 62220-1-3:2008)
Ta slovenski standard je istoveten z: EN 62220-1-3:2008
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 62220-1-3
NORME EUROPÉENNE
September 2008
EUROPÄISCHE NORM
ICS 11.040.50
English version
Medical electrical equipment -
Characteristics of digital X-ray imaging devices -
Part 1-3: Determination of the detective quantum efficiency -
Detectors used in dynamic imaging
(IEC 62220-1-3:2008)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Caractéristiques des dispositifs d'imagerie Merkmale digitaler Röntgenbildgeräte -
numérique à rayonnement X - Teil 1-3: Bestimmung der
Partie 1-3: Détermination de detektiven Quanten-Ausbeute -
l'efficacité quantique de détection - Bildempfänger für
Détecteurs utilisés en imagerie dynamique dynamische Bildgebung
(CEI 62220-1-3:2008) (IEC 62220-1-3:2008)

This European Standard was approved by CENELEC on 2008-07-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62220-1-3:2008 E
Foreword
The text of document 62B/694/FDIS, future edition 1 of IEC 62220-1-3, 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 was approved by CENELEC as EN 62220-1-3 on 2008-07-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2009-04-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-07-01
In this standard, terms printed in SMALL CAPITALS are used as defined in IEC/TR 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.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
- 3 - EN 62220-1-3:2008
Endorsement notice
The text of the International Standard IEC 62220-1-3:2008 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 NOTE  Harmonized as EN 62220-1:2004 (not modified).
IEC 62220-1-2 NOTE  Harmonized as EN 62220-1-2:2007 (not modified).
IEC 61262-5 NOTE  Harmonized as EN 61262-5:1994 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

1) 2)
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
3)
IEC 61267 1994 Medical diagnostic X-ray equipment - EN 61267 1994
Radiation conditions for use in the
determination of characteristics

ISO 12232 1998 Photography - Electronic still-picture - -
cameras - Determination of ISO speed

1)
Undated reference.
2)
Valid edition at date of issue.
3)
IEC 61267:2005 is harmonised as EN 61267:2006 (not modified).

- 5 - EN 62220-1-3:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC

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 may be applicable to the products falling within
the scope of this standard.
IEC 62220-1-3
Edition 1.0 2008-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Characteristics of digital X-ray imaging devices –
Part 1-3: Determination of the detective quantum efficiency – Detectors used in
dynamic imaging
Appareils électromédicaux – Caractéristiques des dispositifs d’imagerie
numérique à rayonnement X –
Partie 1-3: Détermination de l'efficacité quantique de détection – Détecteurs
utilisés en imagerie dynamique

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.50 ISBN 2-8318-9826-9

– 2 – 62220-1-3 © IEC:2008
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 LAG EFFECTS.16
4.6.4 IRRADIATION to obtain the CONVERSION FUNCTION .16
4.6.5 IRRADIATION for determination of the NOISE POWER SPECTRUM and LAG
EFFECTS .16
4.6.6 IRRADIATION with TEST DEVICE in the RADIATION BEAM.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 LAG EFFECTS corrected NOISE POWER SPECTRUM (NPS) .20
6.3.3 Determination of the MODULATION TRANSFER FUNCTION (MTF).24
7 Format of conformance statement .24
8 Accuracy .25
Annex A (informative) Determination of LAG EFFECTS.26
Annex B (informative) Calculation of the input NOISE POWER SPECTRUM .29
Bibliography.30
Index of defined terms .32

Figure 1 – TEST DEVICE .12
Figure 2 – Geometry for exposing the DIGITAL X-RAY IMAGING DEVICE in order to
determine the CONVERSION FUNCTION, the NOISE POWER SPECTRUM and the MODULATION
TRANSFER FUNCTION behind the TEST DEVICE.14
Figure 3 – Image acquisition sequence to determine the NOISE POWER SPECTRUM and
LAG EFFECTS.17
Figure 4 – Geometric arrangement of the ROIs .21
Figure A.1 – Power spectral density of white noise s and correlated signal g (only
positive frequencies are shown).27

62220-1-3 © IEC:2008 – 3 –
Table 1 – RADIATION QUALITY (IEC 61267:1994) for the determination of DETECTIVE
QUANTUM EFFICIENCY and corresponding parameters .11
Table 2 – Necessary IRRADIATIONS .
...