SIST EN 60601-2-45:2011

SLOVENSKI STANDARD
01-maj-2011
1DGRPHãþD
SIST EN 60601-2-45:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DPDPRJUDILMRLQVWHUHRWDNWLþQLKQDSUDY]D
PDPRJUDILMR,(&
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and
essential performance of mammographic X-ray equipment and mammographic
stereotactic devices (IEC 60601-2-45:2011)
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgen-
Mammographiegeräten und mammographischen Stereotaxie- Einrichtungen (IEC 60601-
2-45:2011)
Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques stéréotaxiques (CEI 60601-2-45:2011)
Ta slovenski standard je istoveten z: EN 60601-2-45:2011
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-45
NORME EUROPÉENNE
March 2011
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 60601-2-45:2001

English version
Medical electrical equipment -
Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment and mammographic
stereotactic devices
(IEC 60601-2-45:2011)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-45: Exigences particulières pour Teil 2-45: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de Leistungsmerkmale von Röntgen-
mammographie à rayonnement X et des Mammographiegeräten und
appareils mammographiques mammographischen Stereotaxie-
stéréotaxiques Einrichtungen
(CEI 60601-2-45:2011) (IEC 60601-2-45:2011)

This European Standard was approved by CENELEC on 2011-03-17. 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, Croatia, 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

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-45:2011 E
Foreword
The text of document 62B/817/FDIS, future edition 3 of IEC 60601-2-45, 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 60601-2-45 on 2011-03-17.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
This European Standard supersedes EN 60601-2-45:2001.
March 2010. Further modifications have been made with respect to the current technology of
MAMMOGRAPHIC X-RAY EQUIPMENT.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-12-17
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2014-03-17
with the EN have to be withdrawn
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR
STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

- 3 - EN 60601-2-45:2011
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
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 (93/423/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-45:2011 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 60601-2-7:1998 NOTE  Harmonized as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28:2010 NOTE  Harmonized as EN 60601-2-28:2010 (not modified).
IEC 60601-2-32:1994 NOTE  Harmonized as EN 60601-2-32:1994 (not modified).
IEC 60664-1:2007 NOTE  Harmonized as EN 60664-1:2007 (not modified).
ISO 4090:2001 NOTE  Harmonized as EN ISO 4090:2004 (not modified).
ISO 12052 NOTE  Harmonized as EN ISO 12052 (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.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace IEC 60601-1-2 and IEC 60601-1-3 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
Add:
IEC 60336 2005 Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots

IEC 60613 2010 Electrical and loading characteristics of X-ray EN 60613 2010
tube assemblies for medical diagnosis

IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61223-3-2 2007 Evaluation and routine testing in medical EN 61223-3-2 2008
imaging departments -
Part 3-2: Acceptance tests - Imaging
performance of mammographic X-ray
equipment
IEC 62220-1-2 2007 Medical electrical equipment - Characteristics EN 62220-1-2 2007
of digital X-ray imaging devices -
Part 1-2: Determination of the detective
quantum efficiency - Detectors use in
mammography
ISO 9236-3 1999 Photography - Sensitometry of screen/film - -
systems for medical radiography -
Part 3: Determination of sensitometric curve
shape, speed and average gradient for
mammography
- 5 - EN 60601-2-45:2011
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 60601-2-45 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential performance
of mammographic X-ray equipment and mammographic stereotactic devices

Appareils électromédicaux –
Partie 2-45: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de mammographie à rayonnement X et des appareils
mammographiques stéréotaxiques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.50 ISBN 978-2-88912-347-6

– 2 – 60601-2-45  IEC:2011
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 Hazardous situations and fault conditions . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
203 Radiation protection in diagnostic X-ray equipment . 23
Annex AA (informative) Particular guidance and rationale . 46
Bibliography . 48
Index of defined terms used in this particular standard. 49

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 38

60601-2-45  IEC:2011 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment
and mammographic stereotactic devices

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 60601-2-45 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This third edition cancels and replaces the second edition published in 2001. This edition
rd
constitutes a technical revision. The document has been aligned to the 3 edition of
IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with
respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT.

– 4 – 60601-2-45  IEC:2011
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/817/FDIS 62B/821/RVD
Full information on the voting for the approval of this particular 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.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
–
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website

60601-2-45  IEC:2011 – 5 –
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.
– 6 – 60601-2-45  IEC:2011
INTRODUCTION
The third edition of this particular standard has been prepared to provide a complete set of
rd
safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on IEC 60601-1:2005 (3
edition) and its collaterals. This particular standard addresses the system level of
MAMMOGRAPHIC X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR,
associated equipment and ACCESSORIES. Components functions are addressed as far as
necessary.
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of MAMMOGRAPHIC X-RAY EQUIPMENT.
Like the previous edition of this Part 2-45, the present third edition includes requirements on
HIGH-VOLTAGE GENERATORS for mammography.

60601-2-45  IEC:2011 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-45: Particular requirements for the basic safety and essential
performance of mammographic X-ray equipment
and mammographic stereotactic devices

201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also
referred to as ME EQUIPMENT.
NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or
integrated storage phosphor subsystems.
Excluded from the scope of this document are:
– reconstructive tomography modes of operation;
– diagnostic consoles;
– picture archiving and communication systems (PACS);
– non-integrated storage phosphor readers;
– hard copy cameras;
– films, screens and cassettes;
– computer aided detection (CAD);
– devices for performing core biopsy and other biopsy instruments;
– modes of operation intended to demonstrate local contrast medium uptake (contrast
enhanced digital mammography);
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
rd
NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3 edition scheme for MAMMOGRAPHIC X-RAY
EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC
STEREOTACTIC DEVICES, to ensure safety, to specify methods for demonstrating compliance
with those requirements and to provide guidance for RISK MANAGEMENT.
___________
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

– 8 – 60601-2-45  IEC:2011
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2007 and IEC 60601-1-3:2008 apply as modified in Clauses 202 and 203,
respectively. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, and IEC 60601-1-11 do not
2)
apply . All other published collateral standards in the IEC 60601-1-X series apply as
published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard or a collateral
standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g., 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g., 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
___________
2)
IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for environmentally conscious design.
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers. IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment

60601-2-45  IEC:2011 – 9 –
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g., 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding, clause or subclause in this particular standard, the clause
or subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 48.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
Addition:
IEC 60336:2005, Medical electrical equipment – X-ray tube assemblies for medical
diagnosis – Characteristics of focal spots
IEC 60613:2010, Electrical and loading characteristics of X-ray tube assemblies for medical
diagnosis
IEC 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments –
Part 3-2: Acceptance tests – Imaging performance of mammographic X-ray equipment
IEC 62220-1-2:2007, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in
mammography
ISO 9236-3:1999, Photography – Sensitometry of screen/film systems for medical
radiography – Part 3: Determination of sensitometric curve shape, speed and average
gradient for mammography
– 10 – 60601-2-45  IEC:2011
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1-3:2008 and IEC/TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is found beginning on page 49.
Addition:
201.3.201
APPARENT RESISTANCE OF SUPPLY MAINS
resistance of the SUPPLY MAINS determined under specific load conditions
201.3.202
AVERAGE GLANDULAR DOSE
AGD
average absorbed dose in the glandular tissue (excluding skin) in a
uniformly compressed breast of known tissue composition, using a specified calculation
method
[IEC 61223-3-2:2007, definition 3.7]
NOTE The terms “AVERAGE GLANDULAR DOSE” and “mean glandular dose” are interchangeable according to
literature use.
201.3.203
BREAST COMPRESSION DEVICE
device used to exert pressure upon the breast of a PATIENT during either examination or
treatment
201.3.204
DEFECTIVE DETECTOR ELEMENT
element of an X-RAY IMAGE RECEPTOR whose response is out of acceptable tolerance, such as
when output is independent of the entrance AIR KERMA, or there is an excessive NOISE level
201.3.205
DIRECT FOCAL DISTANCE
shortest achievable distance from the FOCAL SPOT to the IMAGE
RECEPTION AREA
201.3.206
MAMMOGRAPHIC STEREOTACTIC DEVICE
device for three-dimensional localization of a point within the breast, and for mechanically
guided placement of a needle or position marker for such purposes as fine-needle aspiration,
core biopsy, and pre-surgical localization, based on radiographic images of an immobilized
breast acquired at different known angles
NOTE Such a device may be a dedicated system or an ACCESSORY for MAMMOGRAPHIC X-RAY EQUIPMENT.
201.3.207
MAMMOGRAPHIC X-RAY EQUIPMENT
X-RAY EQUIPMENT where the INTENDED USE is breast imaging
201.3.208
ORIGINAL DATA
DN
RAW DATA to which the corrections allowed in this standard have been applied
[IEC 62220-1-2:2007, definition 3.11]

60601-2-45  IEC:2011 – 11 –
NOTE Here “this standard” is to be understood in the context of IEC 62220-1-2:2007.
201.3.209
RAW DATA
PIXEL values read directly after the analogue-digital-conversion from the digital X-ray imaging
device or counts from photon counting systems without any software corrections
[IEC 62220-1-2:2007, definition 3.13]
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 *Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.103
AUTOMATIC CONTROL SYSTEM 203.6.5
Imaging performance 203.6.7
Missed tissue at chest wall side 203.8.5.4.101
BREAST COMPRESSION DEVICE 203.8.5.4.102
Linearity of AIR KERMA over limited intervals of LOADING FACTORS 203.6.3.1.2
Reproducibility of the X-RADIATION output 203.6.3.2

201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of SUPPLY MAINS is to be considered sufficiently low for the operation
of MAMMOGRAPHIC X-RAY EQUIPMENT if the value of the APPARENT RESISTANCE OF SUPPLY MAINS
does not exceed the value specified in the ACCOMPANYING DOCUMENTS.
The required APPARENT RESISTANCE OF SUPPLY MAINS and other appropriate SUPPLY MAINS
requirements shall be provided in the ACCOMPANYING DOCUMENTS.
MAMMOGRAPHIC X-RAY EQUIPMENT is considered to comply with the requirements of this
standard only if its specified NOMINAL electric power can be demonstrated at an APPARENT
RESISTANCE OF SUPPLY MAINS having a value not less than that specified by the MANUFACTURER
in the ACCOMPANYING DOCUMENTS.
NOTE If a NOMINAL voltage is claimed for a mains power supply system, it is assumed that there is no voltage of a
higher value between any of the conductors of the system or between any of these conductors and earth.
An alternating voltage is considered in practice to be sinusoidal if any instantaneous value of the waveform
concerned differs from the instantaneous value of the ideal waveform at the same moment by no more than ± 2 %
of the peak value of the ideal waveform.

– 12 – 60601-2-45  IEC:2011
Three-phase SUPPLY MAINS are considered to have a practical symmetry if it delivers symmetrical voltages and
produces, when loaded symmetrically, symmetrical currents.
The requirements of this standard are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems may be derived from such three-
phase systems. Where the supply system is not earthed at the source, it is assumed that adequate measures have
been provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
Additional subclause:
201.4.101 Data recording
Means shall be incorporated into the ME EQUIPMENT to record the following information with the
image when acquired with an integrated digital X-RAY IMAGE RECEPTOR,:
– identity of the PATIENT (at least name and date of birth);
– positioning information (left/right breast, angulations, PATIENT positioning);
– acquisition parameters;
– place and date of the image acquisition.
When transferring any of the above noted information as image data, it is recommended to
use the objects identified in the DICOM standard (ISO 12052).
The instructions for use shall give appropriate guidance to the OPERATOR.
Compliance is checked by inspection.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electrical shock
Replacement:
MAMMOGRAPHIC X-RAY EQUIPMENT shall be CLASS I ME EQUIPMENT or INTERNALLY POWERED
equipment.
If MAMMOGRAPHIC X-RAY EQUIPMENT is classified as INTERNALLY POWERED ME EQUIPMENT, the
related clauses of the general standard apply and the RISK MANAGEMENT is to be provided
accordingly.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.6 Connection to the SUPPLY MAINS
Addition:
60601-2-45  IEC:2011 – 13 –
For MAMMOGRAPHIC X-RAY EQUIPMENT that is specified to be PERMANENTLY INSTALLED, the
information required in 7.2.6 of the general standard may be stated in the ACCOMPANYING
DOCUMENTS only.
201.7.2.7 Electrical input power from the SUPPLY MAINS
Addition:
For MAMMOGRAPHIC X-RAY EQUIPMENT that is intended to be PERMANENTLY INSTALLED, the
information required in 7.2.7 of the general standard may be stated in the ACCOMPANYING
only.
DOCUMENTS
The information on the input power shall be specified in terms of combinations of
a) the rated MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of the general
standard,
b) the number of phases; see 7.2.1 and 7.2.6 of the general standard,
c) the frequency, in hertz; see 7.2.1 and 7.2.6 of the general standard,
d) the maximum permissible value for APPARENT RESISTANCE OF SUPPLY MAINS, in ohms;
e) the characteristics of over-current releases required in the SUPPLY MAINS.
NOTE These requirements are adapted from IEC 60601-2-7:1998, subclause 6.1j).
201.7.2.15 Cooling conditions
Addition:
If cooling is necessary for safe operation of ME EQUIPMENT, or a subassembly thereof, the
cooling requirements shall be indicated in the ACCOMPANYING DOCUMENTS, including as
appropriate:
– the maximum heat dissipation into the surrounding air, given separately for each
subassembly that dissipates more than 100 W and might be separately located on
installation;
– the maximum heat dissipation into forced air cooling devices, and the corresponding flow
rate and temperature rise of the forced air stream;
– the maximum heat dissipation into a cooling medium utility and the permissible input
temperature range, minimum flow rate and pressure requirements for the utility.
Additional subclause:
201.7.2.101 BEAM LIMITING DEVICE
BEAM LIMITING DEVICES shall be provided with the following markings:
– those required in 7.2.2 of the general standard;
– serial designation or individual identification;
– PERMANENT FILTRATION in terms of QUALITY EQUIVALENT FILTRATION.
The markings on the BEAM LIMITING DEVICE may be hidden by covers in NORMAL USE. In this
case the marking for PERMANENT FILTRATION shall be repeated in the ACCOMPANYING
DOCUMENTS.
NOTE The BEAM LIMITING DEVICE is not in the scope of IEC 60601-2-28:2010. Therefore these requirements have
been adapted from IEC 60601-2-28:1993 subclause 6.1.

– 14 – 60601-2-45  IEC:2011
201.7.8 Indicator lights and controls
Additional subclauses:
201.7.8.101 Indication of X-ray related states
The indication of X-ray related states shall be excluded from 7.8 in the general standard.
Subclause 203.6.4.2 shall apply instead.
201.7.8.102 Alternate visual indication means
Alternate unambiguous visual indication means may be used instead of indicator lights.
Alternate unambiguous visual indication means may use indicator lights of red, yellow, and
green colour.
These means shall be explained in the instructions for use.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall state the dimensions and locations of all available
EFFECTIVE IMAGE RECEPTION AREAS.
For MAMMOGRAPHIC X-RAY EQUIPMENT the ACCOMPANYING DOCUMENTS shall contain quality
control procedures to be performed on the MAMMOGRAPHIC X-RAY EQUIPMENT by the
RESPONSIBLE ORGANISATION. These shall include acceptance criteria and frequency for the
tests.
The performance of means required to present the images for diagnostic purpose shall be
ACCOMPANYING DOCUMENTS.
stated in the
NOTE Examples of such means are image display devices or hard copy cameras.
Additionally for MAMMOGRAPHIC X-RAY EQUIPMENT provided with an integrated digital X-RAY
IMAGE RECEPTOR, the ACCOMPANYING DOCUMENTS shall contain:
– a description of the file transfer format of the images acquired with this unit and of any
data associated with these images;
– identification of the version of image processing applied to ORIGINAL DATA.
Information displayed on the user interface may be considered to satisfy the second
requirement above.
The ACCOMPANYING DOCUMENTS of any MAMMOGRAPHIC STEREOTACTIC DEVICE designed as an
ACCESSORY for MAMMOGRAPHIC X-RAY EQUIPMENT shall contain:
– at least one MODEL OR TYPE REFERENCE to MAMMOGRAPHIC X-RAY EQUIPMENT with which it is
designed to operate;
– a reference to the relevant standards with which the MAMMOGRAPHIC STEREOTACTIC DEVICE
complies.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

60601-2-45  IEC:2011 – 15 –
201.7.9.2 Instructions for use
201.7.9.2.1 General
Addition:
The instructions for use shall describe
– inspection and safe use of all compression plates that are provided with MAMMOGRAPHIC X-
RAY EQUIPMENT,
– methods for determining and resolving problems with ARTEFACTS;
– for MAMMOGRAPHIC X-RAY EQUIPMENT provided with an integrated digital X-RAY IMAGE
RECEPTOR,
• particular handling and maintenance of X-RAY IMAGE RECEPTOR,
• how to use the means required in 203.6.7.4.2 related to
– DEFECTIVE DETECTOR ELEMENTS,
– replacement of data originating from DEFECTIVE DETECTOR ELEMENTS,
– image homogeneity problems;
• the procedure for performing quality control of X-RAY IMAGE RECEPTOR;
• requirements for image presentation.
Electric output data shall be stated in the instructions for use in terms of LOADING FACTORS as
described below in items a) to j) of this subclause 201.7.9.2.1.
The following combinations and data shall be stated:
a) the NOMINAL X-RAY TUBE VOLTAGE and the highest X-RAY TUBE CURRENT available at that
voltage;
b) the highest X-RAY TUBE CURRENT and the highest X-RAY TUBE VOLTAGE available at that
current;
c) the corresponding combination of X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT which
results in the highest electric output power;
d) the NOMINAL electric power given as the highest constant electric output power in kilowatts
RAY GENERATOR can deliver at an X-RAY TUBE VOLTAGE of 30 kV, for a LOADING
which the X-
TIME of 1 s, a CYCLE TIME of 1,0 minute and for an indefinite number of cycles, or if these
values are not selectable, at an X-RAY TUBE VOLTAGE nearest to 30 kV, for a LOADING TIME
nearest to but not less than 1 s and a CYCLE TIME of 1,0 minute and for an indefinite
number of cycles.
NOTE 101 The limitation in the NOMINAL electric power may be caused by the HIGH-VOLTAGE GENERATOR, the X-
RAY TUBE ASSEMBLY or other parts.
e) The NOMINAL electric power shall be given together with the combination of X-RAY TUBE
VOLTAGE and X-RAY TUBE CURRENT and the LOADING TIME;
NOTE 102 The values stated are only for characterising the equipment.
f) for MAMMOGRAPHIC X-RAY EQUIPMENT indicating pre-calculated or measured CURRENT TIME
PR
...