EN 60601-2-45:2001

SLOVENSKI STANDARD
01-november-2002
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Medical electrical equipment - Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-
45:2001)
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit
von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen
(IEC 60601-2-45:2001)
Appareils électromédicaux - Partie 2-45: Règles particulières de sécurité pour les
appareils de radiographie mammaire et les appareils mammographiques stéréotaxiques
(CEI 60601-2-45:2001)
Ta slovenski standard je istoveten z: EN 60601-2-45:2001
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-45
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2001
ICS 11.040.50 Supersedes EN 60601-2-45:1998
English version
Medical electrical equipment
Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
(IEC 60601-2-45:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-45: Règles particulières Teil 2-45: Besondere Festlegungen
de sécurité pour les appareils de für die Sicherheit von Röntgen-
radiographie mammaire et les appareils Mammographiegeräten und
mammographiques stéréotaxiques mammographischen Stereotaxie-
(CEI 60601-2-45:2001) Einrichtungen
(IEC 60601-2-45:2001)
This European Standard was approved by CENELEC on 2001-07-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-45:2001 E
Foreword
The text of document 62B/427/FDIS, future edition 2 of IEC 60601-2-45, prepared by SC 62B,
Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted
to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-45 on 2001-07-01.
This European Standard supersedes EN 60601-2-45:1998.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-04-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-07-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes AA and CC are normative and annex BB is informative.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN OTHER
IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE  Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may not align with
the provisions of this standard.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-45:2001 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60417-2 NOTE  Harmonized as EN 60417-2:1998 (not modified).
IEC 60601-2-32 NOTE  Harmonized as EN 60601-2-32:1994(not modified).
IEC 60613 NOTE  Harmonized as EN 60613:1990 (not modified).
__________
NORME CEI
INTERNATIONALE
IEC
60601-2-45
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2001-05
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour
les appareils de radiographie mammaire et les
appareils mammographiques stéréotaxiques

Medical electrical equipment –
Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices

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МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-45  IEC:2006 – 3 –
CONTENTS
FOREWORD.7

SECTION 1: GENERAL
1 Scope and object .11
1.1 Scope.11
1.2 Object.11
1.3 Particular standards.13
2 Terminology and definitions .15
2.101 Additional definitions.17
3 General requirements .19
5 Classification.19
6 Identification, marking and documents .19
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .19
6.7 Indicator lights and push-buttons .23
6.8 ACCOMPANYING DOCUMENTS .23

SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions .29

SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy.31
16 ENCLOSURES and PROTECTIVE COVERS .31
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.31
19.3 Allowable values.31
20 Dielectric strength.33
20.3 Values of test voltages.33
20.4 Tests.35

SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.37
21.101 Application of maximum compression force .37
22 Moving parts.41
22.101 Motion of X-RAY TUBE – image receptor assembly.41
22.102 COMPRESSION DEVICE .41
22.103 MAMMOGRAPHIC STEREOTACTIC DEVICE .45
24 Stability in NORMAL USE.47

SECTION 5: PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION.49
29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT .49

60601-2-45  IEC:2006 – 5 –
29.207 PRIMARY PROTECTIVE SHIELDING .55
29.208 Protection against STRAY RADIATION.57
36 Electromagnetic compatibility.57

SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.57

SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.59
50.1 General.59
50.101 Indication of electric and RADIATION output .59
50.102 Reproducibility, linearity and constancy.61
50.103 Accuracy of LOADING FACTORS .65
50.104 Test conditions.67
50.105 Conditions for measuring AIR KERMA.69
51 Protection against hazardous output .71

SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly.71
56.7 Batteries.71
57 MAINS PARTS, components and layout.71
57.10 CREEPAGE DISTANCES and AIR CLEARANCES .73

Annex AA (normative) Terminology – Index of defined terms .77
Annex BB (informative) Rationale for allowing full IRRADIATION of mammograms .83
Annex CC (normative) Values of the series R'10 and R'20, ISO 497.85

Bibliography .87

Figure 101 – Example of a test device for MAMMOGRAPHIC STEREOTACTIC DEVICES .75

Table 101 – Tests for verifying reproducibility and linearity .71

60601-2-45  IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-45: Particular requirements for the safety 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-
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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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-45 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1998 and constitutes a
technical revision.
60601-2-45  IEC:2006 – 9 –
This bilingual version (2006-02) replaces the English version.
The text of this Particular Standard is based on the following documents:
FDIS Report of voting
62B/427/FDIS 62B/438/RVD
The French version of this standard has not been voted upon.
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
explanations, advice, notes, general statements and exceptions: smaller roman type;
–
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN
OTHER IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may
not align with the provisions of this standard.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result 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.
60601-2-45  IEC:2006 – 11 –
MEDICAL ELECTRICAL EQUIPMENT –

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

SECTION 1: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard contains requirements for the safety of X-RAY EQUIPMENT designed for
mammography and MAMMOGRAPHIC STEREOTACTIC DEVICES. The safety requirements for the
X-RAY GENERATOR and its sub-assemblies form an integral part of this standard.
1.2 Object
Replacement:
The object of this standard is
1 to formulate appropriate design and manufacturing requirements for the safety of
mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, reflecting the
particular characteristics and circumstances of use of such equipment;
2 to establish particular requirements to ensure safety and to specify methods for
demonstrating compliance with those requirements.
NOTE 1 Requirements for reproducibility, linearity, constancy and accuracy are given because of their relationship
to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered necessary for
safety.
NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the
safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinations
of LOADING FACTORS specified for the tests are therefore limited in number but chosen from experience as being
appropriate in most cases. It is considered important to standardize the choice of combinations of LOADING FACTORS
so that comparison can be made between tests performed in different places on different occasions. However,
combinations other than those specified could be of equal technical validity.
NOTE 3 The safety philosophy on which this standard is based is described in the introduction to the General
Standard and in IEC 60513.
60601-2-45  IEC:2006 – 13 –
NOTE 4 Concerning RADIOLOGICAL PROTECTION it has been assumed in the preparation of this standard that
MANUFACTURERS and USERS do accept the general principles of the International Commission on Radiological
)
Protection (ICRP) as stated in ICRP 60, 1990, paragraph 112, namely:
"(a) No practice involving exposures to radiation should be adopted unless it produces sufficient benefit to the
exposed individuals or to society to offset the radiation detriment it causes. (The justification of a practice.)
(b) In relation to any particular source within a practice, the magnitude of individual doses, the number of people
exposed and the likelihood of incurring exposures where these are not certain to be received should all be kept as
low as reasonably achievable, economic and social factors being taken into account. This procedure should be
constrained by restrictions on the doses to individuals (dose constraints), or the risks to individuals in the case of
potential exposures (risk constraints), so as to limit the inequity likely to result from the inherent economic and
social judgements. (The optimisation of protection.)
(c) The exposure of individuals resulting from the combination of all the relevant practices should be subject to
dose limits, or to some control of risk in the case of potential exposures. These are aimed at ensuring that no
individual is exposed to radiation risks that are judged to be unacceptable from these practices in any normal
circumstances. Not all sources are susceptible of control by action at the source and it is necessary to specify the
sources to be included as relevant before selecting a dose limit. (Individual dose and risk limits.)"
NOTE 5 Most of the requirements on X-RAY EQUIPMENT and its sub-assemblies for protection against IONIZING
RADIATION are given in the Collateral Standard IEC 60601-1-3.
This standard does, however, deal with some aspects of RADIOLOGICAL PROTECTION, mainly those that depend upon
the supply, control and indication of electrical energy from the HIGH-VOLTAGE GENERATOR.
NOTE 6 It is recognized that many of the judgements necessary to follow the ICRP general principles have to be
made by the USER and not by the MANUFACTURER of the EQUIPMENT.
1.3 Particular standards
Addition:
This Particular Standard, hereinafter referred to as "this standard", amends and supplements a
set of IEC publications, hereinafter referred to as "General Standard", consisting of
IEC 60601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety, its
amendments 1 (1991) and 2 (1995) and all Collateral Standards.
The numbering of sections, clauses and subclauses of this standard corresponds to that of the
General Standard. 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 is replaced
completely by the text of this standard.
"Addition" means that the text of this standard is additional to the requirements of the General
Standard.
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
___________
1)
ICRP Publication 60: Recommendations of the International Commission on Radiological Protection (Annals of
the ICRP Vol. 21 No 1-3, 1990). Published by Pergamon Press.

60601-2-45  IEC:2006 – 15 –
Where there is no corresponding section, clause or subclause in this standard, the section,
clause or subclause of the General Standard applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this standard.
A requirement of this standard replacing or modifying requirements of the General Standard
takes precedence over the original requirements concerned.
1.3.101 Related International Standards
IEC 60601-2-28:1993, Medical electrical equipment – Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60664-1:1992, Insulation coordination for equipment within low-voltage systems – Part 1:
Principles, requirements and tests
IEC 60788:1984, Medical radiology – Terminology
IEC 61223-3-2:1996, Evaluation and routine testing in medical imaging departments – Part 3-2:
Acceptance tests – Imaging performance of mammographic X-RAY EQUIPMENT
ISO 497:1973, Guide to the choice of series of preferred numbers and of series containing
more rounded values of preferred numbers
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Associated conditions qualifying the usage of certain terms are given in 2.102.
a) In this standard unless otherwise indicated:
– values of X-RAY TUBE VOLTAGE refer to peak values, transients being disregarded;
– values of X-RAY TUBE CURRENT refer to average values.
b) The electric power in the high-voltage circuit mentioned in 6.8.2 a) 3) and 6.8.2 a) 4) is
calculated according to the formula:
P = f U I
where
P is the electric power;
f is the factor depending on the waveform of the X-RAY TUBE VOLTAGE, selected as below and
is:
a) 0,95 for SIX-PEAK HIGH-VOLTAGE GENERATORS; or
b) 1,00 for TWELVE-PEAK HIGH-VOLTAGE GENERATORS and CONSTANT POTENTIAL high-voltage
generators; or
c) for other HIGH-VOLTAGE GENERATORS, the most appropriate value, 0,95 or 1,00, chosen
according to the waveform of the X-RAY TUBE VOLTAGE, with a statement of the value
selected;
U is the X-RAY TUBE VOLTAGE;
I is the X-RAY TUBE CURRENT.
60601-2-45  IEC:2006 – 17 –
2.101 Additional definitions
In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions
either in the General Standard, in this standard, in IEC 60788 or in other IEC standards
referenced in annex AA.
NOTE Attention is drawn to the fact that, in cases where the concept addressed is not strongly confined to the
definition given in one of the publications listed above, a corresponding term is printed in lower case letters.
An index of defined terms used in this standard is given in annex AA.
For the purposes of this standard, the following additional definitions apply.
2.101.1 Not used.
2.101.2
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. The localization is based on radiographic images of
an immobilized breast acquired at different known angles. Such a device may be a dedicated
system or an ACCESSORY for mammographic X-RAY EQUIPMENT
2.101.3
CORE BIOPSY GUN
automatic needle device for performing core biopsy
2.101.4
DIRECT FOCAL DISTANCE
shortest distance from the X-RAY IMAGE RECEPTOR to the position of the FOCAL SPOT
2.102 Qualifying conditions for defined terms
2.102.1
operating conditions for NOMINAL X-RAY TUBE VOLTAGE
NOMINAL X-RAY TUBE VOLTAGE is defined in IEC 60788 (rm-36-03) as the highest permitted
X-RAY TUBE VOLTAGE for specific operating conditions. In this standard, if specific operating
conditions are not stated, it is to be assumed that the value referenced is unconditional and is
thus the highest X-RAY TUBE VOLTAGE permitted for NORMAL USE of the item under
consideration. Such a value cannot be higher, but is sometimes lower, than values permitted
for certain separate sub-assemblies or parts of the item
2.102.2
PERCENTAGE RIPPLE in CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS
Unless otherwise stated, it is to be assumed that for a HIGH-VOLTAGE GENERATOR to be
regarded as a CONSTANT POTENTIAL HIGH-VOLTAGE GENERATOR, the PERCENTAGE RIPPLE of its
output voltage (under the relevant conditions) does not exceed 4
2.102.3
RADIATION QUANTITY for NOMINAL SHORTEST IRRADIATION TIME
The definition of NOMINAL SHORTEST IRRADIATION TIME refers to a required constancy of a
RADIATION QUANTITY. In this standard the RADIATION QUANTITY concerned is AIR KERMA

60601-2-45  IEC:2006 – 19 –
2.102.4
IRRADIATION TIME
Generally the IRRADIATION TIME is measured in terms of LOADING TIME as the time interval
between:
− the instant that the X-RAY TUBE VOLTAGE has risen for the first time to a value of 75 % of the
peak value; and
− the instant at which it finally drops below the same value
3 General requirements
This clause of the General Standard applies except as follows:
Addition:
Mammographic X-RAY EQUIPMENT shall be designed so as not to deliver in NORMAL USE to any
connected X-RAY TUBE ASSEMBLY a voltage greater than the NOMINAL X-RAY TUBE VOLTAGE for
the X-RAY TUBE ASSEMBLY concerned.
5 Classification
This clause of the General Standard applies except as follows:
5.1 Replacement:
Mammographic X-RAY EQUIPMENT shall be CLASS I EQUIPMENT or INTERNALLY POWERED
EQUIPMENT.
5.6 Replacement:
Unless otherwise specified, mammographic X-RAY EQUIPMENT or sub-assemblies thereof shall
be classified as suitable for continuous connection to the SUPPLY MAINS in the STAND-BY STATE
and for specified LOADINGS; see also 6.1 m) and 6.8.101.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
g) Connection to the supply
Addition:
– For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, the
information required in 6.1 g) of the General Standard may be stated in the ACCOMPANYING
DOCUMENTS only.
60601-2-45  IEC:2006 – 21 –
h) Supply frequency
Addition:
– For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, the
information required in 6.1 h) of the General Standard may be stated in the ACCOMPANYING
DOCUMENTS only.
j) Power input
Addition:
For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, the following
information may be stated in the ACCOMPANYING DOCUMENTS only.
The information on the power input shall be specified in terms of combinations of:
1) the rated MAINS VOLTAGE of the mammographic X-RAY EQUIPMENT in volts; see item g);
2) the number of phases; see item g);
3) the frequency in hertz; see item h);
4) the maximum permissible value for apparent resistance of supply mains in ohms;
5) the characteristics of OVER-CURRENT RELEASES required in the supply mains.
m) Mode of operation
Replacement:
The mode of operation – where appropriate, together with maximum permissible ratings – shall
be stated in the ACCOMPANYING DOCUMENTS; see 6.8.101.
n) Fuses
Addition:
For mammographic X-RAY EQUIPMENT that is specified to be permanently installed, this
subclause of the General Standard does not apply; see item j).
p) Output
Replacement:
This subclause of the General Standard does not apply.
Addition:
aa) Marking of compliance
If, for a mammographic X-RAY EQUIPMENT or sub-assembly thereof, compliance with this
standard is to be marked on the outside of the EQUIPMENT, such marking shall be made in
combination with the MODEL OR TYPE REFERENCE as follows:
+)
IEC 60601-2-45
+)
MODEL OR TYPE REFERENCE
60601-2-45  IEC:2006 – 23 –
6.7 Indicator lights and push-buttons
a) Colours of indicator lights
Addition after the first paragraph:
For a mammographic X-RAY EQUIPMENT, the colours to be used for indicator lights shall be as
follows:
– the colour green shall be used at the CONTROL PANEL to indicate the state from which one
further action leads to the LOADING STATE, if this state is indicated by a single function
indicator light;
– for any indication of the LOADING STATE the colour yellow shall be used to indicate.
NOTE The colours of indicator lights need to be chosen according to the message to be given. Thus, the same
operational state of an EQUIPMENT can have simultaneous indications in different colours depending upon the place
of indication, for example green at the CONTROL PANEL and red at the entrance to the EXAMINATION ROOM.
6.8 ACCOMPANYING DOCUMENTS
6.8.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall include a declaration of the dimensions of all available
X-RAY FIELDS.
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.
6.8.2 INSTRUCTIONS FOR USE
a) General information
Addition:
– INSTRUCTIONS FOR USE shall contain instructions for the inspection and safe use of all
compression plates used with the mammographic X-RAY EQUIPMENT.
– INSTRUCTIONS FOR USE of mammographic stereotactic devices shall contain:
• instructions for the safe handling and use of needles and CORE BIOPSY GUNS;
• the designation of the types of needles and CORE BIOPSY GUNS with which they are
designed to be used, including a warning against the use of any other types.
Electric output data shall be stated in the INSTRUCTIONS FOR USE in terms of LOADING FACTORS
as described in 6.8.2 a) 1) to 6.8.2 a) 6).

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The following combinations and data shall be stated:
1) the NOMINAL X-RAY TUBE VOLTAGE and the highest X-RAY TUBE CURRENT available at that
voltage;
2) the highest X-RAY TUBE CURRENT and the highest X-RAY TUBE VOLTAGE available at that
current;
3) the corresponding combination of X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT which
results in the highest electric output power;
4) the NOMINAL ELECTRIC POWER given as the highest constant electric output power in
kilowatts which the X-RAY GENERATOR can deliver, for a LOADING TIME of 0,1 s at an X-RAY
TUBE VOLTAGE of 30 kV or, if these values are not selectable, with an X-RAY TUBE VOLTAGE
nearest to 30 kV and the value of LOADING TIME nearest to but not less than 0,1 s.
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 The values stated are only for characterising the equipment.
5) for mammographic X-RAY EQUIPMENT indicating precalculated or measured CURRENT TIME
PRODUCT, the lowest CURRENT TIME PRODUCT or the combinations of LOADING FACTORS
resulting in the lowest CURRENT TIME PRODUCT.
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;
6) for mammographic X-RAY EQUIPMENT provided with automatic exposure control controlling
the IRRADIATION TIME, the nominal shortest IRRADIATION TIME.
If the NOMINAL SHORTEST IRRADIATION 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
NOMINAL SHORTEST IRRADIATION TIME is valid shall be stated.
For mammographic X-RAY EQUIPMENT provided with AUTOMATIC EXPOSURE CONTROL controlling
the X-RAY TUBE VOLTAGE or the X-RAY TUBE CURRENT, 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.
Addition:
CONTROLLED AREA
The INSTRUCTIONS FOR USE shall draw the attention of the USER to the need to restrict access to
the EQUIPMENT in accordance with local regulations for RADIOLOGICAL PROTECTION.

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6.8.3 Technical description
Addition:
aa) cooling conditions
The accompanying documents shall state the cooling requirements for safe operation of the
mammographic X-RAY EQUIPMENT, including:
– information concerning the heat dissipation into the surrounding air during NORMAL USE; and
– if applicable, information concerning the heat to be removed in NORMAL USE by any external
cooling medium, and the details necessary for the provision concerned.
6.8.101 Reference to ACCOMPANYING DOCUMENTS
The following clauses and subclauses of this standard contain additional requirements
concerning the content of ACCOMPANYING DOCUMENTS:
Mode of operation and specified LOADINGS. 5.6 and 6.1 m)
Connection to the supply .6.1 g)
Number of phases of SUPPLY MAINS . 6.1 g) and 6.1 j) 2)
Frequency of SUPPLY MAINS . 6.1 h) and 6.1 j) 3)
Power input.6.1 j)
MAINS VOLTAGE.6.1 j) 1)
APPARENT RESISTANCE OF SUPPLY MAINS .6.1 j) 4) and 10.2.2
OVER-CURRENT RELEASE .6.1 j) 5)
Fuses .6.1 n)
Cooling conditions. 6.8.3aa)
Electric output data, combinations of LOADING FACTORS.6.8.2 a) and 50.101
Suitable combinations for compliance test . 50.1
Compliance with this standard. 6.8.102
Central connection point PROTECTIVE EARTH CONDUCTOR . 19.3
Range and interrelation of LOADING FACTORS. 29.1.102 e)
Test conditions for AUTOMATIC EXPOSURE CONTROL . 29.1.102 e)
Method to check the AUTOMATIC EXPOSURE CONTROL . 29.1.104 d)
Combinations with the mammographic X-RAY EQUIPMENT . 50.1
Suitable test combinations. 50.1
LOADING FACTORS and modes of operation . 50.101.1 a)
LOADING FACTORS in fixed combinations. 50.101.2
Density correction of AUTOMATIC EXPOSURE CONTROL. 50.102.2 dd) 2)

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6.8.102 Statement of compliance
If for a mammographic X-RAY EQUIPMENT, or for a sub-assembly, compliance with this standard
is to be stated, the statement shall be made in the following form:
++)
mammographic X-RAY EQUIPMENT . IEC 60601-2-45:2001
++)
MODEL OR TYPE REFERENCE
SECTION 2: ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply except as follows:
10 Environmental conditions
This clause of the General Standard applies except as follows:
10.2.2 Power supply
Item a)
Addition:
The internal impedance of a SUPPLY MAINS is to be considered sufficiently low for the operation
of a mammographic X-RAY EQUIPMENT if the value of the APPARENT RESISTANCE OF SUPPLY MAINS
does not exceed the value specified according to 6.1 j) 4).
NOTE 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 and include a neutral conductor, and that
single-phase systems are derived from such three-phase systems. A 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 the APPARENT RESISTANCE
OF SUPPLY MAINS specified according to 6.1 j) 4).
For this purpose, the APPARENT RESISTANCE OF SUPPLY MAINS R is determined according to the
formula:
-
U U
0 1
R =
I1
where
U is the no-load MAINS VOLTAGE;
U is the MAINS VOLTAGE under load;
I is the mains current under load.
The MAINS VOLTAGE shall be measured between
– phase and neutral in a single-phase system;
– phase and phase in a two-phase system;
– each two phases in a three-phase system.

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The APPARENT RESISTANCE OF SUPPLY MAINS shall be measured by applying a single resistive
load of a value corresponding approximately to the NOMINAL ELECTRIC POWER specified
according to 6.8.2 a) 4), but not more than 5 kW.

SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
15 Limitation of voltage and/or energy
This clause of the General Standard applies except as follows:
Addition:
aa) Detachable high-voltage cable connections to the X-RAY TUBE ASSEMBLY shall be
designed so that the use of TOOLS is required to disconnect them or to remove their
PROTECTIVE COVERS
Compliance is checked by inspection.
bb) Provision shall be made to prevent the appearance of an unacceptably high voltage in
the MAINS PART or in any other low-voltage circuit.
NOTE This may be achieved for example:
– by provision of a winding layer or a conductive screen connected to the protective earth terminal between
high-voltage and low-voltage circuits;
– by provision of a voltage-limiting device across terminals to which external devices are connected and between
which an excessive voltage might arise if the external path becomes discontinuous.
Compliance is checked by inspection of design data and construction.
16 ENCLOSURES and PROTECTIVE COVERS
This clause of the General Standard applies except as follows:
Addition:
NOTE Requirements concerning the resistance and earthing of a flexible conductive screen of high-voltage cables
connected to X-RAY TUBE ASSEMBLIES are given in IEC 60601-2-28.
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
This clause of the General Standard applies except as follows:
19.3 Allowable values
Addition:
For mammographic X-RAY EQUIPMENT and sub-assemblies thereof the column on Type B and
the rows on EARTH LEAKAGE CURRENT in NORMAL CONDITION and SINGLE FAULT CONDITION and on
ENCLOSURE LEAKAGE CURRENT in NORMAL CONDITION of table IV, including the notes, of the
General Standard apply.
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The allowable values of EARTH LEAKAGE CURRENT are permitted for each sub-assembly of a
mammographic X-RAY EQUIPMENT that is supplied by its own exclusive connection to the SUPPLY
MAINS or to a central connection point, if the latter is
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