IEC 60601-2-45:2011

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

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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
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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
PRODUCT, the lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS
resulting in the lowest CURRENT TIME PRODUCT;
g) if the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
upon certain combinations of values of LOADING FACTORS, the lowest CURRENT TIME
PRODUCT may be given as a table or curve showing the dependence;
h) for MAMMOGRAPHIC X-RAY EQUIPMENT provided with AUTOMATIC EXPOSURE CONTROL
controlling the LOADING TIME, the shortest LOADING TIME and/or the lowest resulting
CURRENT TIME PRODUCT;
– 16 – 60601-2-45  IEC:2011
i) if the X-RAY TUBE VOLTAGE or the X-RAY TUBE CURRENT in MAMMOGRAPHIC X-RAY EQUIPMENT
is controlled by an AUTOMATIC EXPOSURE CONTROL, the range of the X-RAY TUBE VOLTAGE or
the X-RAY TUBE CURRENT during the IRRADIATION shall be stated in the instructions for use;
j) if the shortest LOADING TIME depends upon LOADING FACTORS such as X-RAY TUBE VOLTAGE
and X-RAY TUBE CURRENT, the ranges of these LOADING FACTORS for which the shortest
LOADING TIME is valid shall be stated.
The instructions for use shall draw the attention of the RESPONSIBLE ORGANISATION to the need
to restrict access to ME EQUIPMENT in accordance with local regulations for RADIATION
PROTECTION.
201.7.9.3 Technical description
Additional subclauses:
201.7.9.3.101 Specification of X-RAY SOURCE ASSEMBLY and its position
The technical description of the integrated X-RAY SOURCE ASSEMBLIES shall specify the
following:
a) specification of the REFERENCE AXIS to which the TARGET angle(s) and the FOCAL SPOT
characteristics of the X-RAY TUBE of the X-RAY SOURCE ASSEMBLY refer;
b) TARGET angle(s) with respect to the specified REFERENCE AXIS;
c) position with tolerances of the FOCAL SPOTS on the REFERENCE AXIS;
d) NOMINAL FOCAL SPOT VALUE(S) determined according to IEC 60336 for the specified
REFERENCE AXIS;
NOTE These requirements are adapted from IEC 60601-2-28:1993 subclause 6.8.3 dd).
e) possible values for DIRECT FOCAL DISTANCE;
REFERENCE AXIS with the IMAGE RECEPTION AREA for a
f) position of the intersection of the
specified DIRECT FOCAL DISTANCE;
g) angle of the REFERENCE AXIS to the plane of the IMAGE RECEPTION AREA.
Additional paragraph:
201.7.9.101 Reference to ACCOMPANYING DOCUMENTS
The following subclauses of this standard contain additional requirements concerning the
content of ACCOMPANYING DOCUMENTS:
201.4.10.2 . SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
SUPPLY MAINS
201.7.2.6 . Connection to the
201.7.2.7 . Electrical input power from the SUPPLY MAINS
201.7.2.15 . Cooling conditions
203.5.2 . ACCOMPANYING DOCUMENTS
203.6.2.1.101……………………………………………………….Connections of external interlocks
203.6.5 . AUTOMATIC CONTROL SYSTEM
ADIATION DETECTOR or X-RAY IMAGE RECEPTOR
203.6.7.4 . R
203.7.3 . Indication of FILTER properties
RESIDUAL RADIATION
203.11.101 . Additional requirements for protection against
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:

60601-2-45  IEC:2011 – 17 –
201.8.4 Limitation of voltage, current or energy
Additional subclauses:
201.8.4.101 HIGH-VOLTAGE CABLE CONNECTIONS
Detachable HIGH-VOLTAGE CABLE CONNECTIONS shall either be designed so that the use of tools
is required to disconnect them or they shall be provided with interlocks so that at all times
when protective covers or high-voltage connections are removed:
– the ME EQUIPMENT is disconnected from its power supply, and
– capacitances in the high-voltage circuit are discharged within the minimum time necessary
to gain access to the high-voltage circuit, and
– the discharged state is maintained.
Compliance is checked by inspection and by measurement.
NOTE These requirements are adapted from IEC 60601-2-7:1998 subclause 15 aa).
201.8.4.102 Limitation of X-RAY TUBE VOLTAGE
ME EQUIPMENT shall be designed so as not to deliver in INTENDED USE, to any connected X-RAY
, a voltage greater than the NOMINAL X-RAY TUBE VOLTAGE for the X-RAY TUBE
TUBE ASSEMBLY
concerned or greater than the NOMINAL X-RAY TUBE VOLTAGE the X-RAY TUBE ASSEMBLY is
designed for, whichever is the lower voltage.
NOTE These requirements are adapted from IEC 60601-2-7:1998 subclause 3.1.
201.8.5 Separation of parts
201.8.5.4 Working voltage
Addition:
201.8.5.4.101 Stator and stator circuit dielectric strength testing
The test voltage for the dielectric strength testing of stator and stator circuit used for the
operation of the rotating anode of the X-RAY TUBE is to be referred to the voltage existing after
reduction of the stator supply voltage to its steady state operating value.
NOTE These requirements are adapted from IEC 60601-2-7:1998 subclause 20.4 l).
201.8.6 Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT
Additional paragraphs:
201.8.6.101 X-RAY TUBE ASSEMBLY
Accessible high-voltage cables connecting the X-RAY TUBE ASSEMBLY to the HIGH-VOLTAGE
shall incorporate a flexible conductive screen, having a resistance per unit length
GENERATOR
-1
not exceeding 1 Ω m , and covered with a non-conductive material capable of protecting the
screen against mechanical damage. The screen shall be connected to the protective earth
conductive ENCLOSURE of the HIGH-VOLTAGE GENERATOR in low impedance.
Compliance is checked by visual inspection and by measurement.
201.8.6.102 X-RAY SOURCE ASSEMBLY
In all cases, there shall be electrical continuity between the screen of a fitted high-voltage
cable and the accessible metal parts of its rec
...

IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2809-8

IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 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 . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
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 for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 23
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 . 24
Annex AA (informative) Particular guidance and rationale . 47
Bibliography . 49
Index of defined terms used in this particular standard. 50

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 . 39

+AMD1:2015 CSV  IEC 2015
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
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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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-45 edition 3.1 contains the third edition (2011-02) [documents 62B/817/FDIS
and 62B/821/RVD] and its amendment 1 (2015-06) [documents 62B/917/CDV and
62B/954/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is
available in this publication.

– 4 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
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 2008). Further modifications have been
made with respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT.
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

+AMD1:2015 CSV  IEC 2015
The committee has decided that the contents of the base publication and its amendment 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.
NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
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.

INTRODUCTION to Amendment 1
This first amendment to the third edition of this particular standard has been prepared to
provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, and
IEC60601-1-3:2008 and IEC60601-1-3:2008/AMD1:2013. This particular standard addresses
the system level of MAMMOGRAPHIC X-RAY EQUIPMENT and introduces equipment for
MAMMOGRAPHIC TOMOSYNTHESIS.
+AMD1:2015 CSV  IEC 2015
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, including equipment for MAMMOGRAPHIC TOMOSYNTHESIS, 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 other than MAMMOGRAPHIC TOMOSYNTHESIS;
– CT SCANNERS covered by IEC 60601-2-44;
– 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);
ME EQUIPMENT only, or to
If a clause or subclause is specifically intended to be applicable 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
___________
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

– 8 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
STEREOTACTIC DEVICES, to ensure safety, to specify methods for demonstrating compliance
with those requirements and to provide guidance for RISK MANAGEMENT.
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 2014 and IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013
apply as modified in Clauses 202 and 203, respectively. IEC 60601-1-8, IEC 60601-1-9,
2)
IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not 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.
___________
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. IEC 60601-1-12:2004, Medical Electrical
Equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems used in the emergency medical
services environment.
+AMD1:2015 CSV  IEC 2015
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.
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 49.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007 2014, 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
IEC 60601-1-3:2008/AMD1:2013
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 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013, 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 axis of
symmetry of the EFFECTIVE IMAGE RECEPTION AREA perpendicular to its chest wall edge for a
specified position of the source
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 1 Such a device may be a dedicated system or an ACCESSORY for MAMMOGRAPHIC X-RAY EQUIPMENT.
NOTE 2 The purposes of such devices may be fine-needle aspiration, core biopsy, or pre-surgical localization.
201.3.207
MAMMOGRAPHIC X-RAY EQUIPMENT
X-RAY EQUIPMENT where the INTENDED USE is breast imaging

+AMD1:2015 CSV  IEC 2015
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]
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]
201.3.210
MAMMOGRAPHIC TOMOSYNTHESIS
technique using MAMMOGRAPHIC X-RAY EQUIPMENT to produce multiple tomographic images
reconstructed from multiple PROJECTIONS acquired over a total angular range of less than 180°
201.3.211
CONTRAST TO NOISE RATIO
CNR
physical quantity describing the ability to distinguish between various contrast objects of a
digital image and the inherent noise within the image, defined as the difference of mean pixel
values of the contrast objects and image background, and divided by the standard deviation
of the image background pixel value
[SOURCE: IEC 61223-3-2:2007, definition 3.8]
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 203.6.4.3.103 102
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

– 12 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
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.
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;
– identification and version of image processing applied to ORIGINAL DATA and, in
MAMMOGRAPHIC TOMOSYNTHESIS, identification and version of reconstruction processing
applied.
NOTE An example for processed images are DICOM images for presentation.
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.

+AMD1:2015 CSV  IEC 2015
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:
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
DOCUMENTS only.
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:
– 14 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
– 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.
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.
+AMD1:2015 CSV  IEC 2015
The performance of means required to present the images for diagnostic purpose shall be
stated in the ACCOMPANYING DOCUMENTS.
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:
MODEL OR TYPE REFERENCE to MAMMOGRAPHIC X-RAY EQUIPMENT with which it is
– at least one
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.
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;
– 16 – IEC 60601-2-45:2011
+AMD1:2015 CSV  IEC 2015
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
which the X-RAY GENERATOR can deliver at an X-RAY TUBE VOLTAGE of 30 kV, for a LOADING
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
PRODUCT, the lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS
resulting in the lowest CURRENT TIME PRODUCT;
g) if the value of the lowest CURRENT TIME PRODUCT depends upon the X-RAY TUBE VOLTAGE or
LOADING FACTORS, the lowest CURRENT TIME
upon certain combinations of values of
PRODUCT may be given as a table or curve showing the dependence;
h) for MAMMOGRAPHIC X-RAY EQUIPMENT provided with AUTOMATIC EXPOSURE CONTROL
controlling the LOADING TIME, the shortest
...

IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-5241-3

IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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

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CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
INTRODUCTION to Amendment 2 . 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 . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against
hazardous outputs . 23
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic compatibility – Requirements and tests . 24
203 Radiation protection in diagnostic X-ray equipment . 24
Annex AA (informative) Particular guidance and rationale . 48
Bibliography . 51
Index of defined terms used in this particular standard. 53

Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 12
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 40

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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-45 edition 3.2 contains the third edition (2011-02) [documents 62B/817/FDIS
and 62B/821/RVD], its amendment 1 (2015-06) [documents 62B/917/CDV and
62B/954/RVC] and its amendment 2 (2022-08) [documents 62B/1271/CDV and
62B/1282/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
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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
edition of
constitutes a technical revision. The document has been aligned to the 3
IEC 60601-1 (2005) and to IEC 60601-1-3 (20102008), Amendment 1 of IEC 60601-1-3 (2013)
and Amendment 2 of IEC 60601-1-3 (2021). Further modifications have been made with
respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT.
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

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The committee has decided that the contents of the base publication and its amendments 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.
NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
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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.

INTRODUCTION to Amendment 1
This first amendment to the third edition of this particular standard has been prepared to
MAMMOGRAPHIC X-RAY EQUIPMENT, based on
provide a complete set of safety requirements for
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, and
IEC60601-1-3:2008 and IEC60601-1-3:2008/AMD1:2013. This particular standard addresses
the system level of MAMMOGRAPHIC X-RAY EQUIPMENT and introduces equipment for
MAMMOGRAPHIC TOMOSYNTHESIS.
INTRODUCTION to Amendment 2
This second amendment to the third edition of this particular standard has been prepared to
provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on
the second amendment (2020) to IEC 60601-1:2005 and associated collateral standards.
Moreover, in Annex AA the description of the term for ESSENTIAL PERFORMANCE is modified to
better reflect the clarification published as interpretation sheet 1 of IEC 60601-1:2005/
AMD1:2012. This particular standard addresses the system level of MAMMOGRAPHIC X-RAY
EQUIPMENT including the equipment for MAMMOGRAPHIC TOMOSYNTHESIS.

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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, including equipment for MAMMOGRAPHIC TOMOSYNTHESIS, 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 other than MAMMOGRAPHIC TOMOSYNTHESIS;
– CT SCANNERS covered by IEC 60601-2-44;
– 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);
ME EQUIPMENT only, or to
If a clause or subclause is specifically intended to be applicable 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
___________
1)
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

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STEREOTACTIC DEVICES, to ensure safety, to specify methods for demonstrating compliance
with those requirements and to provide guidance for RISK MANAGEMENT.
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 60601-1-2:20072014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply as modified in
Clauses 202 and 203, respectively. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10,
2)
IEC 60601-1-11 and IEC 60601-1-12 do not 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.
___________
2)
IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential
performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems. 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.
IEC 60601-1-12:2004, Medical electrical equipment – Part 1-12: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used intended for use in the emergency medical services environment.

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"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.
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 51.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:20072014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
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
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
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 TR 60788:2004, Medical electrical equipment – Glossary of defined terms

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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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013, 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 axis of
symmetry of the EFFECTIVE IMAGE RECEPTION AREA perpendicular to its chest wall edge for a
specified position of the source
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,

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core biopsy, and pre-surgical localization, based on radiographic images of an immobilized
breast acquired at different known angles
NOTE 1 Such a device may be a dedicated system or an ACCESSORY for MAMMOGRAPHIC X-RAY EQUIPMENT.
NOTE 2 The purposes of such devices may be fine-needle aspiration, core biopsy, or pre-surgical localization.
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]
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]
201.3.210
MAMMOGRAPHIC TOMOSYNTHESIS
technique using MAMMOGRAPHIC X-RAY EQUIPMENT to produce multiple tomographic images
reconstructed from multiple PROJECTIONS acquired over a total angular range of less than 180°
201.3.211
CONTRAST TO NOISE RATIO
CNR
physical quantity describing the ability to distinguish between various contrast objects of a
digital image and the inherent noise within the image, defined as the difference of mean pixel
values of the contrast objects and image background, and divided by the standard deviation
of the image background pixel value
[SOURCE: IEC 61223-3-2:2007, definition 3.8]
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 potential ESSENTIAL PERFORMANCE requirements
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed
in Table 201.101.
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Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.103102
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.
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;

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– identification and version of image processing applied to ORIGINAL DATA and, in
MAMMOGRAPHIC TOMOSYNTHESIS, identification and version of reconstruction processing
applied.
NOTE An example for processed images are DICOM images for presentation.
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:
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
DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of

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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.
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.
+AMD2:2022 CSV  IEC 2022
These means shall be explained in the instructions for use.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.8.1 Colours of indicator lights
Addition:
Yellow and green colours of lights which are listed in Table 2 of the general standard should
only be used if they are clearly distinguishable from the indication the X-ray related states as
required in Subclause 203.6.4.2.
If applicable, conflicts which may arise from using same or similar colours for indication of X-
RAY related states and other functions of the ME EQUIPMENT shall be evaluated by using the
USABILITY ENGINEERING process.
Colours of indicator lights and alarm indicator lights for ME EQUIPMENT which are designated as
HIGH PRIORITY, MEDIUM PRIORITY, and LOW PRIORITY ALARM CONDITION listed in Table 2 of the
general standard do not apply to this particular standard.
NOTE Even though 7.8 of the general standard mentions the collateral standard IEC 60601-1-8 which application
is excluded in 201.1.3 of this particular standard, the selected specified references therein are considered
informative and help to understand the requirements of 7.8.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
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
MAMMOGRAPHIC X-RAY EQUIPMENT by the
control procedures to be performed on 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
stated in the ACCOMPANYING DOCUMENTS.
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:

– 16 – IEC 60601-2-45:2011+AMD1:2015
+AMD2:2022 CSV  IEC 2022
– 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.
Instructions for use
201.7.9.2
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 pr
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