SIST EN 60601-2-45:2011/A2:2024

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-45. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za mamografijo in stereotaktičnih naprav za
mamografijo - Dopolnilo A2 (IEC 60601-2-45:2011/A2:2022)
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/A2:2022)
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten
und mammographischen Stereotaxie-Einrichtungen (IEC 60601-2-45:2011/A2:2022)
Appareils électromédicaux - Partie 2-45: Exigences particulières pour la sécurite de base
et les performances essentielles des appareils de mammographie à rayonnement X et
des appareils mammographiques steréotaxiques (IEC 60601-2-45:2011/A2:2022)
Ta slovenski standard je istoveten z: EN 60601-2-45:2011/A2:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-45:2011/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
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/A2:2022)
Appareils électromédicaux - Partie 2-45: Exigences Medizinische elektrische Geräte - Teil 2-45: Besondere
particulières pour la sécurite 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
steréotaxiques Stereotaxie-Einrichtungen
(IEC 60601-2-45:2011/A2:2022) (IEC 60601-2-45:2011/A2:2022)
This amendment A2 modifies the European Standard EN 60601-2-45:2011; it was approved by CENELEC on 2022-09-06. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-45:2011/A2:2024 E

European foreword
The text of document 62B/1271/CDV, future edition 3 of IEC 60601-2-45/A2, prepared by SC 62B
"Medical imaging equipment, software, and systems" of IEC/TC 62 "Medical equipment, software, and
systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-
2-45:2011/A2:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-03-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-09-20
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 shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-45:2011/A2:2022 was approved by CENELEC as
a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where 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.cencenelec.eu.
Replace EN 60601-1-2:2015 with:
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
Replace EN 60601-1-3:2008 with:
Publication Year Title EN/HD Year
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + AC 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
Replace:
Publication Year Title EN/HD Year
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-45 ®
Edition 3.0 2022-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
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 978-2-8322-4876-8

– 2 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

AMENDMENT 2
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 2 to IEC 60601-2-45:2011 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:
Draft Report on voting
62B/1271/CDV 62B/1282/RVC
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.

IEC 60601-2-45:2011/AMD2:2022 – 3 –
© IEC 2022
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document 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 Amendment 2
This second 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
the second amendment (2020) to IEC 60601-1:2005 and associated collateral standards.
Moreover, in Annex AA the description of the term for ESSENTIAL PERFORMANCE is modified to
better reflect the clarification published as interpretation sheet 1 of IEC 60601-1:2005/
AMD1:2012. This particular standard addresses the system level of MAMMOGRAPHIC X-RAY
EQUIPMENT including the equipment for MAMMOGRAPHIC TOMOSYNTHESIS.

– 4 – IEC 60601-2-45:2011/AMD2:2022
© IEC 2022
FOREWORD
Replace, in the second paragraph, “IEC 60601-1-3 (2008)”, modified by Amendment 1, with
“IEC 60601-1-3 (2008), Amendment 1 of IEC 60601-1-3 (2013) and Amendment 2 of IEC 60601-
1-3 (2021)”.
201.1 Scope, object and related sta
...