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

IEC 60601-2-45 ®
Edition 3.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 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

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

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

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IEC 60601-2-45 ®
Edition 3.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 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

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 978-2-8322-2785-5

– 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.
This bilingual version (2015-07) corresponds to the English version, published in 2015-06.
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 French version of this amendment has not been voted upon.
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• withdrawn,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.
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 IEC 60601-
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
Delete, in the second paragraph, the phrase "detect PATIENT contact and".
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-radiation
Replace, in the first paragraph, the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-
3:2008 and IEC 60601-1-3:2008/AMD1:2013".

201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Replace the existing text of this clause by the following:
Clause 12 of the general standard applies.

201.13 Hazardous situations and fault conditions
Replace the existing title of this clause by the following:

– 8 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
201.13 Hazardous situations and fault conditions for ME EQUIPMENT

202 Electromagnetic compatibility – Requirements and tests
Replace, in the first line, the reference to "IEC 60601-1-2:2007" by "IEC 60601-1-2:2014".

203 Radiation protection in diagnostic X-ray equipment
Replace, in the first line, the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-3:2008
and IEC 60601-1-3:2008/AMD1:2013".

203.4 General requirements
203.4.1 Statement of compliance
Replace the reference to "IEC 60601-2-45:2011" by "IEC 60601-2-45:2015".
203.4.101.2 * LOADING TIME
Replace in Note 1 the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013".

203.6.3 RADIATION dose and RADIATION QUALITY
RADIATION dose and RADIATION QUALITY
203.6.3.1 Adjustment of
203.6.3.1.1 General requirements for the adjustment of RADIATION dose and RADIATION
QUALITY
Replace, in the second paragraph, the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-
3:2008 and IEC 60601-1-3:2008/AMD1:2013".
203.6.3.1.2 Linearity of AIR KERMA over limited intervals of LOADING FACTORS
Add, at the end of the first dashed item, the following sentence:
For MAMMOGRAPHIC TOMOSYNTHESIS this lower value shall be the lowest CURRENT TIME
PRODUCT setting available in a LOADING of a TOMOSYNTHESIS projection image acquisition
series.
203.6.3.2 Reproducibility of the X-RADIATION output
Add, after the fourth dashed item, the following new dashed item:
– for MAMMOGRAPHIC TOMOSYNTHESIS a combination of X-RAY TUBE VOLTAGE specified by the
MANUFACTURER and clinically justified, with the lowest CURRENT TIME PRODUCT setting
available in a complete LOADING of a TOMOSYNTHESIS acquisition series

 IEC 2015
203.6.4.2.101 LOADING STATE in mammography
Add, after the third paragraph, before the compliance statement, the following new paragraph:
For MAMMOGRAPHIC TOMOSYNTHESIS operation the LOADING STATE shall encompass all acquired
projections.
203.6.4.3 Indication of LOADING FACTORS and MODES of OPERATION
Add, at the beginning of the subclause, after the instruction “Addition:”, the following new text:
For MAMMOGRAPHIC TOMOSYNTHESIS acquisition, which involves multiple IRRADIATIONS, LOADING
FACTORS shall be provided after completion of the acquisition for each of these IRRADIATIONS.
NOTE An example of implementation of this requirement is through usage of DICOM objects.
203.6.4.3.102 Accuracy of LOADING FACTORS
203.6.4.3.102.1 General
Replace, in the compliance statement, the reference to "203.6.4.3.104" by "203.6.4.3.103".
203.6.4.3.102.3 Accuracy of X-RAY TUBE CURRENT
Replace the existing text of this subclause by the following:
For operation of MAMMOGRAPHIC X-RAY EQUIPMENT where the X-RAY TUBE CURRENT can be
independently selected, its value shall be accurate within ± 20 % of the INDICATED VALUE within
the selectable range.
203.6.4.3.102.4 Accuracy of LOADING TIME
Replace the existing first paragraph by the following;
For operation of MAMMOGRAPHIC X-RAY EQUIPMENT where the LOADING TIME can be
independently selected, the error on the value of the LOADING TIME shall not be greater than
± (10 % + 1 ms) for combinations of LOADING FACTORS representing the selectable range.
CURRENT TIME PRODUCT
203.6.4.3.102.5 Accuracy of
Add at the end of this subclause the following new paragraph:
For MAMMOGRAPHIC TOMOSYNTHESIS operation the CURRENT TIME PRODUCT shall be the sum of
the respective CURRENT TIME PRODUCTS of the individual projections.
203.6.4.3.103 Test conditions for the accuracy of loading factors
203.6.4.3.103.1 Accuracy and reproducibility of X-RAY TUBE VOLTAGE
Replace the existing first paragraph by the following:
Measurements shall be made at 30 kV or at the X-RAY TUBE VOLTAGE specified by the
MANUFACTURER if clinically justified. Measurements shall also be made at the lowest and
highest selectable values of the X-RAY TUBE VOLTAGE and at the lowest, medium and highest
selectable values of CURRENT TIME PRODUCT.

– 10 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
Replace, at the beginning of the third paragraph, the phrase "Calculate the average" by
"Check each measured".
203.6.4.5 Dosimetric indications
Add, at the end of this subclause, the following new paragraph:
For MAMMOGRAPHIC TOMOSYNTHESIS the AVERAGE GLANDULAR DOSE to be indicated shall be the
cumulative AVERAGE GLANDULAR DOSE over the entire tomographic acquisition.

203.6.5.3 AEC requirements for MAMMOGRAPHIC X-RAY EQUIPMENT provided with an
integrated digital X-RAY IMAGE RECEPTOR
203.6.5.3.1 General requirements
Add, after the existing first paragraph, the following new paragraph:
For MAMMOGRAPHIC TOMOSYNTHESIS equipment this requirement may be assessed in projection
images.
Replace, in the second sentence of the existing second paragraph, the phrase "magnification
and (if applicable)" by "magnification, (if applicable) tomosynthesis and".
Replace, in the existing third paragraph the phrase "(e.g. magnification and stereotactic
modes)" by "(e.g. magnification, tomosynthesis and stereotactic modes)".
Add the following new text at the end of the note:
and is included in 203.6.5.3.3
203.6.5.3.2 AEC reproducibility
a) Test method
Add, after the dashed list of item a), the following new paragraph:
For MAMMOGRAPHIC TOMOSYNTHESIS equipment the PIXEL values in a region of interest shall be
assessed in projection images of the PHANTOM.
Add the following new subclause:
203.6.5.3.3 AEC thickness response
The response of the AEC to different breast thicknesses shall be evaluated by jointly
assessing image quality, as measured by the CONTRAST TO NOISE RATIO, and the dose to the
PATIENT, as characterized by the AVERAGE GLANDULAR DOSE, and comparing them to the
specifications provided.
a) Test method
Measure the CONTRAST TO NOISE RATIO of radiograms and AVERAGE GLANDULAR DOSE of
PHANTOMS made of breast tissue equivalent material, produced with the AUTOMATIC
EXPOSURE CONTROL in operation. Determine these quantities, in all operational modes, for
PHANTOM thicknesses from 20 mm to 70 mm in steps of 10 mm.

 IEC 2015
b) Compliance criteria
The MEASURED VALUE of the AVERAGE GLANDULAR DOSE shall not exceed the
MANUFACTURER's specification, and the CONTRAST TO NOISE RATIO shall not be lower than
the MANUFACTURER's specification.
For MAMMOGRAPHIC TOMOSYNTHESIS the AVERAGE GLANDULAR DOSE shall be the cumulative
AVERAGE GLANDULAR DOSE over the entire tomographic acquisition.
For MAMMOGRAPHIC TOMOSYNTHESIS the CONTRAST TO NOISE RATIO shall be assessed in
each of the projection images.

203.6.7.104.1 Minimum AIR KERMA RATE
Replace, in the penultimate paragraph before the compliance statement, the reference to
"IEC 60601-1-3:2008" by "IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013".

203.7.3 Indication of FILTER properties
Replace the reference to "IEC 60601-1-3:2008" by "IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013".
203.8 Limitation and indication of the extent of the X-RAY BEAM and relationship
between X-RAY FIELD and IMAGE RECEPTION AREA
203.8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA
203.8.5.3 * Correspondence between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA
Add, at the end of item c), the following new sentence:
For MAMMOGRAPHIC TOMOSYNTHESIS this requirement is excluded.

203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR
203.10.1 General
Add the following new phrase at the end of the existing first paragraph:
when measured perpendicular to these layers.

203.11 Protection against RESIDUAL RADIATION
203.11.101 Additional requirements for protection against RESIDUAL RADIATION
Replace the second and third sentences of the second paragraph of the compliance statement
by the following text:
Fit shielding in the plane of the PATIENT SUPPORT as necessary to exclude from the
measurement any X-RADIATION not transmitted through the PRIMARY PROTECTIVE SHIELDING. For

– 12 – IEC 60601-2-45:2011/AMD1:2015
 IEC 2015
MAMMOGRAPHIC TOMOSYNTHESIS mode of operation, the test shall be performed using a
tomosynthesis sweep. It shall be tested for all available tomosynthesis configurations.

Annex AA – Particular guidance and rationale
AA.1 Rationale for particular clauses and subclauses
Add the following new rationales:
Subclause 201.3.206 – MAMMOGRAPHIC STEREOTACTIC DEVICE
This defined term has been clarified and modified to include MAMMOGRAPHIC TOMOSYNTHESIS
equipment that can be used for three dimensional localization and interventional
mammographic guidance.
Subclause 201.7.9.2.17 – ME EQUIPMENT emitting radiation
This requirement of the general standard is sufficiently addressed through IEC 60601-1-3 and
additional requirements in 201.7.9.
Replace the existing header text of the rationale for subclause 201.9.2.101 by the following:
Subclause 201.9.2.101 – Three dimensional localization and interventional
mammographic guidance
Add, at the end of the rationale to this subclause, the following new paragraph:
Tomosynthesis has been specifically excluded from this subclause because of the possible
movement of the x-ray source during acquisition.
Subclauses 203.8.5.3 – Correspondence between X-RAY FIELD and EFFECTIVE IMAGE
RECEPTION AREA and 203.8.5.4.101 – Missed tissue at chest wall side
Add, at the end of the rationale to this subclause, the following new paragraph:
Because in MAMMOGRAPHIC TOMOSYNTHESIS equipment the angulation of the source may
generate a translation of the beam, the restriction for the correspondence between X-ray field
and effective image reception area has been relaxed, with the exception of the chest wall side.
However, patient protection is ensured by 203.11 Protection against RESIDUAL RADIATION
where the primary protective barrier requirement has been maintained.
Bibliography
Add the following new bibliographic reference
[11] 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 2015
Index of defined terms used in this particular standard
Replace the existing line for CONTRAST TO NOISE RATIO by the following new line:
CONTRAST TO NOISE RATIO . 201.3.211
Replace the existing line for EARTH LEAKAGE CURRENT by the following new line:
EARTH LEAKAGE CURRENT . IEC 60601-1:2005/AMD1:2012, 3.25
Replace the existing line for ESSENTIAL PERFORMANCE by the following new line:
ESSENTIAL PERFORMA
...