IEC 60601-2-45:2011/AMD1:2015

IEC 60601-2-45 ®
Edition 3.0 2015-06
INTERNATIONAL
STANDARD
AMENDMENT 1
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential performance
of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-45:2011-02/AMD1:2015-06(en)

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IEC 60601-2-45 ®
Edition 3.0 2015-06
INTERNATIONAL
STANDARD
AMENDMENT 1
Medical electrical equipment –

Part 2-45: Particular requirements for the basic safety and essential performance

of mammographic X-ray equipment and mammographic stereotactic devices

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-2727-5

– 2 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
CDV Report on voting
62B/917/CDV 62B/954/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base 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• withdrawn,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.
A bilingual version of this publication may be issued at a later date.

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.

_____________
INTRODUCTION TO THE AMENDMENT
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.
 IEC 2015
FOREWORD
Replace, in the second paragraph, the reference to “IEC 60601-1-3 (2010)" by “IEC 60601-1-3
(2008)”.
201.1 Scope, object and related standards
Replace, in footnote 1, the reference to "IEC 60601-1:2005" by "IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012".
201.1.1 Scope
Add, in the first paragraph, after the term "MAMMOGRAPHIC X-RAY EQUIPMENT" the phrase
“including equipment for MAMMOGRAPHIC TOMOSYNTHESIS,“.
Replace, in the first dashed item of the third paragraph, the words "modes of operation" by
"other than MAMMOGRAPHIC TOMOSYNTHESIS"
Add, after this first dashed item, the following new dashed item:
– CT SCANNERS covered by IEC 60601-2-44;

201.1.3 Collateral standards
Replace, in the first sentence of the second paragraph, the reference to "IEC 60601-1-2:2007"
by "IEC 60601-1-2:2014
Replace the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013"
Replace the second sentence of the second paragraph, including its footnote, with the
following new sentence and footnote:
IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not
1.
apply .
_____________
1 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.
– 4 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
201.2 Normative references
Replace the existing references to IEC 60601-1-2:2007 and IEC 60601-1-3:2008 by the
following:
IEC 60601-1-2:2014, 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
Delete the following normative reference:
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

201.3 Terms and definitions
Replace, in the first paragraph, the reference “IEC 60601-1:2005, IEC 60601-1-3:2008” by
"IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-
1-3:2008/AMD1:2013".
201.3.205
DIRECT FOCAL DISTANCE
Replace the existing text of the definition by the following:
shortest 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
Add an asterisk * in front of the term to read
*MAMMOGRAPHIC STEREOTACTIC DEVICE
Replace the existing text of the definition by the following:
device for mechanically guided placement of a needle or position marker based on
radiographic images of an immobilized breast acquired at different known angles
Renumber the existing note as Note 1 and add the following new note:
NOTE 2 The purposes of such devices may be fine-needle aspiration, core biopsy, or pre-surgical localization.

 IEC 2015
Add the following new definitions:
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
201.4.3 ESSENTIAL PERFORMANCE
201.4.3.101 *Additional ESSENTIAL PERFORMANCE requirements
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Replace the subclause reference for "Accuracy of LOADING FACTORS" in the first row, by
"203.6.4.3.102"
201.4.101 Data recording
Add, after the final dashed item in the first paragraph, the following new dashed item and note:
ORIGINAL DATA and, in
– identification and version of image processing applied to
MAMMOGRAPHIC TOMOSYNTHESIS, identification and version of reconstruction processing
applied.
NOTE An example for processed images are DICOM images for presentation.

201.7 ME EQUIPMENT identification, marking and documents
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
Add the following new subclause:
201.7.9.2.17 *ME EQUIPMENT emitting radiation
This subclause of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 does not apply.

– 6 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
201.7.9.3.101 Specification of X-RAY SOURCE ASSEMBLY and its position
Add, in item e), after the term “"DIRECT FOCAL DISTANCE", the following new text:
and, in MAMMOGRAPHIC TOMOSYNTHESIS, for specified positions of the source
Add, in item f), after the term "DIRECT FOCAL DISTANCE" the following new text:
and, in MAMMOGRAPHIC TOMOSYNTHESIS, for specified positions of the source
Add, in item g) after the term "IMAGE RECEPTION AREA" the following new text:
and, in MAMMOGRAPHIC TOMOSYNTHESIS, for specified positions of the source
Add the following new items:
h) in MAMMOGRAPHIC TOMOSYNTHESIS, the number of PROJECTIONS, and the geometric
configuration for the acquisition of the PROJECTIONS;
i) in MAMMOGRAPHIC TOMOSYNTHESIS, description of the distribution of x-ray LOADING FACTORS
for the acquisition of the PROJECTIONS.

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.9.2 HAZARDS associated with moving parts
Replace the existing title with the following:
201.9.2 MECHANICAL HAZARDS associated with moving parts

201.9.2.1 General
PATIENT contact and".
Delete, in the second paragraph, the phrase "detect
201.9.2.3 Other HAZARDS associated with moving parts
Replace the existing title with the following:
201.9.2.3 Other MECHANICAL HAZARDS associated with moving parts

201.9.2.101 * MAMMOGRAPHIC STEREOTACTIC DEVICE
Replace the existing title by the following:
201.9.2.101 * Three dimensional localization and interventional mammographic
guidance
201.9.2.101.1 Positioning of X-RAY SOURCE ASSEMBLY for stereotactic imaging
Add after the first paragraph, before the compliance statement, the following new paragraph:
This subclause does not apply for MAMMOGRAPHIC TOMOSYNTHESIS.

 IEC 2015
201.9.2.101.3 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC
DEVICES
Replace the existing title by the following:
201.9.2.101.3 Biopsy needle positioning accuracy
Delete, in the first paragraph, the word "stereotactic".
a) Test equipment
Delete, in the first sentence of the first paragraph and in the second and third sentences of
the second paragraph, the word "stereotactic".
Delete, at the end of the second paragraph, the phrase "with the MAMMOGRAPHIC
STEREOTACTIC DEVICE".
b) Test procedure
Replace, in the third sentence of the first paragraph the phrase "of the MAMMOGRAPHIC
STEREOTACTIC DEVICE" by the word "SPECIFIED". Delete the two other instances of the word
"stereotactic" in this sentence.
Delete in the second paragraph the phrase "with which the MAMMOGRAPHIC STEREOTACTIC
DEVICE is".
Replace the second and third sentences of the third paragraph by the following new text:
"Determine x, y, z positions of the test needle tips as specified by the MANUFACTURER for
clinical use."
Delete, in the fourth sentence of the third paragraph, the phrase "by the MAMMOGRAPHIC
STEREOTACTIC DEVICE".
201.10 Protection against unwanted and excessive radiation HAZARDS
201.10.1.2 ME EQUIPMENT intended to produce diagnostic or therapeutic X-radia
...