EN 62220-1-2:2007

SLOVENSKI STANDARD
01-november-2007
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Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-2:
Determination of the detective quantum efficiency - Mammography detectors (IEC 62220
-1-2:2007)
Medizinische elektrische Geräte - Merkmale digitaler Röntgenbildgeräte - Teil 1-2:
Bestimmung der detektiven Quanten-Ausbeute - Bildempfänger für
Mammographieeinrichtungen (IEC 62220-1-2:2007)
Appareils électromédicaux - Caractéristiques des dispositifs d'imagerie numérique a
rayonnement X -- Partie 1-2: Détermination de l'efficacité quantique de détection -
Détecteurs utilisés en mammographie (IEC 62220-1-2:2007)
Ta slovenski standard je istoveten z: EN 62220-1-2:2007
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 62220-1-2
NORME EUROPÉENNE
September 2007
EUROPÄISCHE NORM
ICS 11.040.50
English version
Medical electrical equipment -
Characteristics of digital X-ray imaging devices -
Part 1-2: Determination of the detective quantum efficiency -
Detectors used in mammography
(IEC 62220-1-2:2007)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Caractéristiques des dispositifs Merkmale digitaler Röntgenbildgeräte -
d'imagerie numérique à rayonnement X - Teil 1-2: Bestimmung
Partie 1-2: Détermination der detektiven Quanten-Ausbeute -
de l'efficacité quantique de détection - Bildempfänger
Détecteurs utilisés en mammographie für Mammographieeinrichtungen
(CEI 62220-1-2:2007) (IEC 62220-1-2:2007)

This European Standard was approved by CENELEC on 2007-09-01. 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

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62220-1-2:2007 E
Foreword
The text of document 62B/649/FDIS, future edition 1 of IEC 62220-1-2, 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 62220-1-2 on 2007-09-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2008-06-01
national standard or by endorsement
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-09-01
In this standard, terms printed in SMALL CAPITALS are used as defined in IEC/TR 60788, in Clause 3 of this
standard or 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.
__________
Endorsement notice
The text of the International Standard IEC 62220-1-2:2007 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 61262-5 NOTE  Harmonized as EN 61262-5:1994 (not modified).
__________
- 3 - EN 62220-1-2:2007
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

1) 2)
IEC 60601-2-45 - Medical electrical equipment - EN 60601-2-45 2001
Part 2-45: Particular requirements for the
safety of mammographic X-ray equipment
and mammographic stereotactic devices

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
IEC 61267 2005 Medical diagnostic X-ray equipment - EN 61267 2006
Radiation conditions for use in the
determination of characteristics

IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -
Part 1: Determination of the detective
quantum efficiency
ISO 12232 1998 Photography - Electronic still-picture - -
cameras - Determination of ISO speed

1)
Undated reference.
2)
Valid edition at date of issue.

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.
INTERNATIONAL IEC
STANDARD
CEI
62220-1-2
NORME
First edition
INTERNATIONALE
Première édition
2007-06
Medical electrical equipment –
Characteristics of digital X-ray imaging devices –
Part 1-2:
Determination of the
detective quantum efficiency –
Detectors used in mammography
Appareils électromédicaux –
Caractéristiques des dispositifs
d’imagerie numérique à rayonnement X –
Partie 1-2:
Détermination de l’efficacité
quantique de détection –
Détecteurs utilisés en mammographie
PRICE CODE
U
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 2 – 62220-1-2 © IEC:2007
CONTENTS
FOREWORD.3
INTRODUCTION.5

1 Scope.6
2 Normative references .6
3 Terminology and definitions .7
4 Requirements .9
4.1 Operating conditions .9
4.2 X-RAY EQUIPMENT .9
4.3 RADIATION QUALITY .9
4.4 TEST DEVICE .10
4.5 Geometry .11
4.6 IRRADIATION conditions.12
5 Corrections of RAW DATA .15
6 Determination of the DETECTIVE QUANTUM EFFICIENCY.16
6.1 Definition and formula of DQE(u,v) .16
6.2 Parameters to be used for evaluation .16
6.3 Determination of different parameters from the images.17
7 Format of conformance statement .21
8 Accuracy .21

Annex A (normative) Determination of LAG EFFECTS.22
Annex B (informative) Calculation of the input NOISE POWER SPECTRUM.25

Bibliography.26

Terminology – Index of defined terms .28

62220-1-2 © IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES –

Part 1-2: Determination of the detective quantum efficiency –
Detectors used in mammography
FOREWORD
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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
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