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
...