IEC 60601-2-45:2011
(Main)Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
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 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.
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
La CEI 60601-2-45:2011 s'applique à la sécurité de base et aux performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques stéréotaxiques. La CEI 60601-2-45:2011 traite du niveau système de l'appareil de mammographie à rayonnement X, qui se compose de la combinaison d'un groupe radiogène, d'appareils associés et d'accessoires. Les fonctions des composants sont abordées pour autant que nécessaire. Les exigences minimales de sécurité spécifiées dans la présente norme particulière sont considérées comme assurant un degré pratique de sécurité dans le fonctionnement des appareils de mammographie à rayonnement X. La précédente édition de la présente Partie 2-45 comprenait les exigences relatives aux générateurs radiologiques pour mammographie, il en est de même pour la présente 3ème édition. Cette troisième édition annule et remplace la deuxième édition publiée en 2001 dont elle constitue une révision technique. Ce document a été aligné sur la 3ème édition de la CEI 60601-1 (2005) et sur la CEI 60601-1-3 (2010). Des modifications supplémentaires ont été apportées, tenant compte de la technologie actuelle des appareils de mammographie à rayonnement X.
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IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
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STANDARD
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Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential performance
of mammographic X-ray equipment and mammographic stereotactic devices
All rights reserved. Unless otherwise specified, 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
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
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IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
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 978-2-8322-2809-8
IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical electrical equipment –
Part 2-45: Particular requirements for the basic safety and essential performance
of mammographic X-ray equipment and mammographic stereotactic devices
– 2 – IEC 60601-2-45:2011
+AMD1:2015 CSV IEC 2015
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
203 Radiation protection in diagnostic X-ray equipment . 24
Annex AA (informative) Particular guidance and rationale . 47
Bibliography . 49
Index of defined terms used in this particular standard. 50
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 39
+AMD1:2015 CSV IEC 2015
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
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 IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-45 edition 3.1 contains the third edition (2011-02) [documents 62B/817/FDIS
and 62B/821/RVD] and its amendment 1 (2015-06) [documents 62B/917/CDV and 62B/954/
RVC].
In this Redline version, a vertical line in the margin shows where the technical
content is modified by amendment 1. Additions and deletions are displayed in
red, with deletions being struck through. A separate Final version with all changes
accepted is available in this publication.
– 4 – IEC 60601-2-45:2011
+AMD1:2015 CSV IEC 2015
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.
This third edition cancels and replaces the second edition published in 2001. This edition
rd
constitutes a technical revision. The document has been aligned to the 3 edition of
IEC 60601-1 (2005) and to IEC 60601-1-3 (2010 2008). Further modifications have been
made with respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website
+AMD1:2015 CSV IEC 2015
The committee has decided that the contents of the base publication and its amendment 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
organ
...
IEC 60601-2-45 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
All rights reserved. Unless otherwise specified, 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 either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
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Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
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IEC 60601-2-45 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.50 ISBN 978-2-88912-347-6
– 2 – 60601-2-45 IEC:2011
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 Hazardous situations and fault conditions . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
203 Radiation protection in diagnostic X-ray equipment . 23
Annex AA (informative) Particular guidance and rationale . 46
Bibliography . 48
Index of defined terms used in this particular standard. 49
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 38
60601-2-45 IEC:2011 – 3 –
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
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 IEC Publication may be the subject of
patent rights. 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.
This third edition cancels and replaces the second edition published in 2001. This edition
rd
constitutes a technical revision. The document has been aligned to the 3 edition of
IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with
respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT.
– 4 – 60601-2-45 IEC:2011
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/817/FDIS 62B/821/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
–
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandator
...
IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
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IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-2809-8
IEC 60601-2-45 ®
Edition 3.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-2-45:2011
+AMD1:2015 CSV IEC 2015
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
203 Radiation protection in diagnostic X-ray equipment . 24
Annex AA (informative) Particular guidance and rationale . 47
Bibliography . 49
Index of defined terms used in this particular standard. 50
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 39
+AMD1:2015 CSV IEC 2015
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
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
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
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services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-45 edition 3.1 contains the third edition (2011-02) [document
...
IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-5241-3
IEC 60601-2-45 ®
Edition 3.2 2022-08
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-2-45:2011+AMD1:2015
+AMD2:2022 CSV IEC 2022
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
INTRODUCTION to Amendment 2 . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against
hazardous outputs . 23
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic compatibility – Requirements and tests . 24
203 Radiation protection in diagnostic X-ray equipment . 24
Annex AA (informative) Particular guidance and rationale . 48
Bibliography . 51
Index of defined terms used in this particular standard. 53
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 12
Table 203.101 – Minimum values of TOTAL FILTRATION and factors for determining the
minimum AIR KERMA RATE . 40
+AMD2:2022 CSV 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
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 IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-45 edition 3.2 contains the third edition (2011-02) [documents 62B/817/FDIS
and 62B/821/RVD], its amendment 1 (2015-06) [documents 62B/917/CDV and
62B/954/RVC] and its amendment 2 (2022-08) [documents 62B/1271/CDV and
62B/1282/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 4 – IEC 60601-2-45:2011+AMD1:2015
+AMD2:2022 CSV IEC 2022
International standard IEC 60601-2-
...
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