SIST EN 60601-2-45:2011/A1:2015

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

Medizinische elektrische Geräte -- Teil 2-45: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen

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

Medicinska električna oprema - 2-45. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za mamografijo in stereotaktičnih naprav za mamografijo - Dopolnilo A1

General Information

• Status: Published
• Publication Date: 09-Nov-2015
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 29-Sep-2015
• Due Date: 04-Dec-2015
• Completion Date: 10-Nov-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-45:2011/A1:2015 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

Relations

• Amends: SIST EN 60601-2-45:2011 - 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)
• Effective Date: 01-Dec-2015
• Amends: SIST EN 60601-2-45:2011 - 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)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-45:2011/A1:2015
01-december-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DPDPRJUDILMRLQVWHUHRWDNWLþQLKQDSUDY]D
PDPRJUDILMR'RSROQLOR$
Medical electrical equipment -- Part 2-45: Particular requirements for the basic safety
and essential performance of mammographic X-ray equipment and mammographic
stereotactic devices
Medizinische elektrische Geräte -- Teil 2-45: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten
und mammographischen Stereotaxie-Einrichtungen
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
Ta slovenski standard je istoveten z: EN 60601-2-45:2011/A1:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-45:2011/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-45:2011/A1:2015

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SIST EN 60601-2-45:2011/A1:2015


EUROPEAN STANDARD EN 60601-2-45:2011/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2015
ICS 11.040.50

English Version
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/A1:2015)
Appareils électromédicaux - Partie 2-45: Exigences Medizinische elektrische Geräte - Teil 2-45: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de mammographie à wesentlichen Leistungsmerkmale von Röntgen-
rayonnement X et des appareils mammographiques Mammographiegeräten und mammographischen
stéréotaxiques Stereotaxie- Einrichtungen
(IEC 60601-2-45:2011/A1:2015) (IEC 60601-2-45:2011/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-45:2011; it was approved by CENELEC on 2015-07-23. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-45:2011/A1:2015 E

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SIST EN 60601-2-45:2011/A1:2015
EN 60601-2-45:2011/A1:2015
European foreword
The text of document 62B/917/CDV, future IEC 60601-2-45:2011/A1, 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 approved by CENELEC as EN 60601-2-45:2011/A1:2015.

The following dates are fixed:
(dop) 2016-04-23
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-07-23
standards conflicting with the
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-45:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-45:2011/A1:2015 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-45:2011, the following note has to be added for the standard
indicated:

IEC 61223-3-2:2007 NOTE Harmonized as EN 61223-3-2:2008 (not modified).
2

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SIST EN 60601-2-45:2011/A1:2015
EN 60601-2-45:2011/A1:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu

Annex ZA of EN 60601-2-45:2011 applies, except as follows:

Publication Year Title EN/HD Year
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 - EN 60601-1-2 2015
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
 Part 1-3: General requirements for basic + corr. March 2010
+A1 2013 safety and essential performance - +A1 2013
Collateral Standard: Radiation protection in +A1/AC 2014
diagnostic X-ray equipment
Delete the following reference:
IEC 61223-3-2 2007 Evaluation and routine testing in medical EN 61223-3-2 2008
imaging departments -
Part 3-2: Acceptance tests - Imaging
performance of mammographic X-ray
equipment

3

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SIST EN 60601-2-45:2011/A1:2015

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SIST EN 60601-2-45:2011/A1:2015



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

























INTERNATIONAL

ELECTROTECHNICAL

COMMISSION






ICS 11.040.50 ISBN 978-2-8322-2727-5



  Warning! Make sure that you obtained this publication from an authorized distributor.


® Registered trademark of the International Electrotechnical Commission

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SIST EN 60601-2-45:2011/A1:2015
– 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.

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SIST EN 60601-2-45:2011/A1:2015
IEC 60601-2-45:2011/AMD1:2015 – 3 –
 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.

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SIST EN 60601-2-45:2011/A1:2015
– 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.

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SIST EN 60601-2-45:2011/A1:2015
IEC 60601-2-45:2011/AMD1:2015 – 5 –
 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.

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SIST EN 60601-2-45:2011/A1:2015
– 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 MAMMOGRAPH
...