IEC 60601-2-45:1998

INTERNATIONAL
IEC
STANDARD
60601-2-45
First edition
1998-09
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety
of mammographic X-ray equipment
and mammographic stereotactic devices

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken by
the technical committee which has prepared this publication, as well as the list of
publications issued, is to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International Electro-
technical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL
IEC
STANDARD
60601-2-45
First edition
1998-09
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety
of mammographic X-ray equipment
and mammographic stereotactic devices

 IEC 1998  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
R
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-45 © IEC:1998(E)

CONTENTS
Page
FOREWORD 3
...................................................................................................................

Clause
SECTION 1: GENERAL
1 Scope and object 5
......................................................................................................

2 Terminology and definitions 6
......................................................................................
6 Identification, marking and documents 7
......................................................................
SECTION 2: ENVIRONMENTAL CONDITIONS
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength 8
..................................................................................................
22 Moving parts 10
.............................................................................................................
24 Stability in NORMAL USE 13
..............................................................................................
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-RADIATION 13
..............................................................................................................
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
Figure 1 – Example of a TEST DEVICE for MAMMOGRAPHIC STEREOTACTIC DEVICES 16
...............
Annexes
AA – Terminology – Index of defined terms 17
......................................................................
BB – Rationale for allowing full IRRADIATION of mammograms 19
...........................................

60601-2-45 © IEC:1998(E) – 3 –

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 IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The 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.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62B/343/FDIS 62B/353/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex AA forms an integral part of this standard.
Annex BB is for information only.
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;

– 4 – 60601-2-45 © IEC:1998(E)

– test specifications: 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.

A bilingual version of this standard may be issued at a later date.

60601-2-45 © IEC:1998(E) – 5 –

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.
1.2  Object
Replacement:
The object of this standard is 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.
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.
– 6 – 60601-2-45 © IEC:1998(E)

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 60601-2-32:1994, Medical electrical equipment – Part 2: Particular requirements for the
safety of associated equipment of X-ray equipment
IEC 60788:1984, Medical radiology – Terminology
2  Terminology and definitions
This clause of the General Standard applies except as follows:
Addition:
2.101  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 purpose of this standard, the following additional definitions apply.
2.101.1
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
2.101.2
CORE BIOPSY GUN
automatic needle device for performing core biopsy

60601-2-45 © IEC:1998(E) – 7 –

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

Addition:
NOTE – For the purpose of this clause, EQUIPMENT or EQUIPMENT parts includes all items that are within the scope
of this standard; see 1.1.
aa)  Marking of compliance
If compliance with this standard is to be marked on an item, such marking shall be made on the
outside of the item in combination with the MODEL OR TYPE REFERENCE as follows:
*) **)
.... IEC 60601-2-45:1998 .
*)
Description of item and MODEL OR TYPE REFERENCE
**)
Year of publication of this standard
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:
– The INSTRUCTIONS FOR USE shall contain instructions for the inspection and safe use of all
compression plates used with the X-RAY EQUIPMENT.
– The 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 and shall contain a warning against the use of any other types.

– 8 – 60601-2-45 © IEC:1998(E)

Addition:
aa)  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.

SECTION 2: ENVIRONMENTAL CONDITIONS

The clauses and subclauses of this section of the General Standard apply.
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply.
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
21  Mechanical strength
This clause of the General Standard applies except as follows:
Addition:
21.101  Application of maximum compression force
21.101.1  Motion of ANTI-SCATTER GRID
For mammographic X-RAY EQUIPMENT with a moving ANTI-SCATTER GRID, the application of the
maximum force attainable for the COMPRESSION DEVICE shall not impede the motion of the ANTI-
SCATTER GRID.
Compliance is determined by the following test:

a) Test equipment
The following test equipment is required:
– appropriately sized objects, one for each image receptor format, leading to sufficiently
realistic force distributions when under compression. The objects shall be sand filled
bags or soft rubber blocks. Their thickness shall be in the range from 20 mm to 50 mm.
For the smallest image receptor format, the object shall be 100 mm to 120 mm long and
wide, and it shall be 120 mm to 150 mm long and wide for larger formats;
– an aluminium plate of 2 mm thickness and of dimensions sufficient to intercept the
whole X-RAY BEAM when mounted as described below;
– if the X-RAY EQUIPMENT uses RADIOGRAPHIC FILMS:
• a densitometer, covering the optical density range from 0 to 3,5;
• RADIOGRAPHIC CASSETTES with INTENSIFYING SCREENS and RADIOGRAPHIC FILMS for
each image format.
60601-2-45 © IEC:1998(E) – 9 –

b) Test procedure
Position the X-RAY TUBE – image receptor assembly to acquire a cranio-caudal projection of
the breast and set the X-RAY EQUIPMENT in a condition that is provided for grid

mammography. Mount a compression plate that is designed for the maximum attainable

compression force and for the image receptor format used. Fix the aluminium plate between

the X-RAY SOURCE ASSEMBLY and the compression plate so that it will completely cover the

RAY BEAM PATIENT SUPPORT
X- . Place the object on the , centred laterally, and with one edge

as close as possible to that edge of the PATIENT SUPPORT that is provided to be adjacent to

the PATIENT's chest wall. If the object is a sand filled bag, shape it by hand to maximize the

surface areas that will be in contact with the PATIENT SUPPORT and the compression plate.

Actuate the breast COMPRESSION DEVICE to the maximum attainable compression force. For

X-RAY EQUIPMENT using RADIOGRAPHIC FILMS, select an X-RAY TUBE VOLTAGE of 25 kV to
30 kV and a CURRENT TIME PRODUCT that will lead to an optical density of 1,0 to 2,0 in the
darkest part of the RADIOGRAPHIC FILM, which will be outside the image of the object under
RADIOGRAPHIC FILM RAY EQUIPMENT
compression. Irradiate and process the . For X- using a
non-film image receptor, select an X-RAY TUBE VOLTAGE and CURRENT TIME PRODUCT
appropriate for the image receptor; irradiate the image receptor and display the image.
Evaluate the RADIOGRAM. In case of impeded grid motion owing to the high compression
force, grid lines or some other image of the ANTI-SCATTER GRID structure will be visible in
the area outside the image of the object under compression.
If the ANTI-SCATTER GRID structure is visible, repeat the test but without applying a
compression force, in order to verify whether the compression force is the cause.
Repeat the test procedure for all image receptor formats.
c) Interpretation of test results
Compliance is achieved if the application of the compression force does not increase the
visibility of the ANTI-SCATTER GRID structure.
21.101.2  Strength of compression plates
Compression plates and their mountings, unless marked to indicate the maximum compression
force permitted to be applied, shall withstand the maximum compression force attainable when
they are fitted to the EQUIPMENT. The marking may take the form of coding related to an
explanation in the INSTRUCTIONS FOR USE.
Compliance is determined by the following test:
a) Test equipment
Test objects as described in 21.101.1 are required.
b) Test procedure
Position the X-RAY TUBE – image receptor assembly to acquire a cranio-caudal projection of
the breast. Mount a compression plate that is designed for the maximum attainable
compression force. Take the test object designed for the same image receptor format as
the compression plate and place it on the PATIENT SUPPORT, centred laterally, and with one
edge as close as possible to that edge of the PATIENT SUPPORT that is provided to be
adjacent to the PATIENT's chest wall. If the object is a sand filled bag, shape it by hand to
maximize the surface areas that will be in contact with the PATIENT SUPPORT and the
compression plate.
Actuate the breast COMPRESSION DEVICE to the maximum attainable compression force.
Then relax the force.
c) Interpretation of test results
Inspect the compression plate and associated parts for any signs of damage, especially for
fissures. For compliance, the compression plates and associated parts are to be free from
breakage, visible damage and permanent distortion.

– 10 – 60601-2-45 © IEC:1998(E)

22  Moving parts
This clause of the General Standard applies except as follows:

Addition:
22.101  Motion of X-RAY TUBE – image receptor assembly

The assembly shall be capable of being rigidly fixed in any position where it is designed to

operate. Once fixed in any such position, the assembly shall not move without OPERATOR

intervention. Movement of the assembly shall require continuous actuation by the OPERATOR. In

the event of interruption of the SUPPLY MAINS, the assembly shall not put any resultant force
exceeding 20 N on any part of the PATIENT.
When the breast COMPRESSION DEVICE is actuated to a force of more than 50 N, the speed or
step size of any power-driven movements of the assembly as a whole shall be limited so that
the OPERATOR will have adequate control for fine correction of its position without endangering
the PATIENT. Motions needed for stereotactic imaging which do not include an intended
movement of the breast are excluded from this requirement.
22.102  COMPRESSION DEVICE
22.102.1  General
All mammographic X-RAY EQUIPMENT shall be fitted with a breast COMPRESSION DEVICE.
22.102.2  Control of compression movements
All switches controlling movement for the application of compression shall be of the type
requiring continuous actuation while movement takes place. The X-RAY EQUIPMENT shall
provide means for hands-free initiation of compression. It shall include means for fine
adjustment of motion during the application of the compression force and for decompression.
All functions shall be accessible from both sides of the position of the PATIENT.
Means shall be provided for the OPERATOR to prevent automatic decompression.
In the event of interruption of SUPPLY MAINS, the compression shall be maintained. However,
means shall be provided for manually achieving complete decompression.
22.102.3  Range of movement
In all conditions of NORMAL USE, the available range of movement of the COMPRESSION DEVICE
shall allow all those parts of the compression plate that are designed to be in contact with the
breast to be brought within 10 mm of the surface of the PATIENT SUPPORT.
NOTE – This requirement is intended to ensure that adequate compression of small or thin breasts is not prevented
by limitation of the available movement of the compression plate. The extent of compression applied to any
particular PATIENT is controlled by the OPERATOR and may be limited by restriction of the available operating force;
see 22.102.5.
22.102.4  Design of compression plates
Compression plates shall be transparent so that the skin of the PATIENT remains visible when in
contact with them. Unless other means for indication are provided, the X-RAY EQUIPMENT shall
include at least one compression plate for each image receptor format used in an AUTOMATIC
EXPOSURE CONTROL mode marked to indicate the range of sensor positions available in NORMAL
USE.
60601-2-45 © IEC:1998(E) – 11 –

22.102.5  Compression force
COMPRESSION DEVICES shall satisfy the following requirements in respect of the application and

indication of the compression force in all orientations specified for NORMAL USE:

– no COMPRESSION DEVICE shall be able to apply a force exceeding 300 N;

– for power-driven compression, the COMPRESSION DEVICE shall be able to apply a force of at

least 150 N, and it shall be unable to apply a force exceeding 200 N;

– for power-driven compression, the available operating force shall be adjustable down to

70 N or less;
– if the value of the applied force is displayed, the indication shall be given in units of force
and shall be accurate to ±20 N.
Compliance is checked by measurement.
a)  Test equipment
The following test equipment is required:
– a force balance;
– a soft rubber block, 20 mm to 50 mm thick, and 100 mm to 120 mm long and wide.
b)  Test procedure
RAY TUBE
Position the X- – image receptor assembly to acquire a cranio-caudal projection of
PATIENT SUPPORT
the breast. Place the force balance on the and fix it so that it will not fall
down in any orientation. Place the soft rubber block on the sensitive area of the force
balance. Operate the COMPRESSION DEVICE, thus clamping the soft rubber block, and record
the reading of the balance. Measure the highest achievable forces for all compression
modes. If the force is displayed at the X-RAY EQUIPMENT then perform at least five additional
measurements for lower compression forces, equally distributed over the range from zero
compression to the maximum attainable compression force and record all displayed values
in combination with the readings of the balance. Repeat the test procedure for at least three
RAY TUBE
other orientations of the X- – image receptor assembly in order to cover the whole
range of angles possible with the X-RAY EQUIPMENT sufficiently.
Repeat this test procedure for all modes of power-driven compression after adjusting the
available operating force down to its minimum.
c) Interpretation of measured data
Determine compliance by comparing MEASURED VALUES with required values and, if the
compression force is displayed, with the above requirements of accuracy.
22.103  MAMMOGRAPHIC STEREOTACTIC DEVICE
22.103.1  Positioning of X-RAY SOURCE ASSEMBLY for stereotactic imaging
In stereotactic imaging, defined angular positions shall be provided for the X-RAY SOURCE
ASSEMBLY. The X-RAY SOURCE ASSEMBLY shall be capable of being rigidly fixed in any of these
positions. Once fixed in any such position, the X-RAY SOURCE ASSEMBLY shall require OPERATOR
intervention to release.
22.103.2  Motion of APPLIED PARTS during imaging and biopsy or marker placing
Under constant compression force, there shall be no displacement between the PATIENT
SUPPORT and the compression plate of more than ±0,5 mm and ±0,5( relative to each other,
and their displacement relative to the PATIENT shall not exceed ±2 mm and ±2(. The movement
of the needle holder or CORE BIOPSY GUN holder with a needle inserted in it shall require
OPERATOR
continuous actuation and control by the .

– 12 – 60601-2-45 © IEC:1998(E)

22.103.3  Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES

The accuracy of biopsy needle tip position in x, y, and z directions shall be within ±1 mm in the

specified stereotactic biopsy volume.

Compliance is checked by measurement.

a) Test equipment
A stereotactic TEST DEVICE of a design which allows testing for different biopsy needle

directions is required for the
...