IEC 60601-2-44:2009
(Main)Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control. The contents of the corrigendum of May 2010 have been included in this copy.
Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie
La CEI 60601-2-44:2009 s'applique à la sécurité de base et aux performances essentielles des tomodensitomètres. Le domaine d'application de la CEI 60601-2-44:2009 est limité aux tomodensitomètres destinés à être utilisés pour les examens de la tête et du corps caractérisés par une enveloppe de la (des) source(s) de rayonnement X et du (des) détecteur(s) d'imagerie dans un couvercle de protection commun de forme toroïdale. Cette norme comprend les exigences de sécurité des générateurs radiologiques utilisés dans les tomodensitomètres, y compris celles pour les générateurs haute tension lorsqu'ils sont intégrés avec une gaine équipée. Cette troisième édition annule et remplace la deuxième édition parue en 2001 et son Amendement 1 (2002). La présente édition constitue une révision technique qui traite essentiellement de la protection contre les rayonnements et de leur contrôle. Le contenu du corrigendum de mai 2010 a été pris en considération dans cet exemplaire.
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IEC 60601-2-44 ®
Edition 3.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de tomodensitométrie
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.
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IEC 60601-2-44 ®
Edition 3.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les
performances essentielles des équipements à rayonnement X de
tomodensitométrie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 978-2-88910-224-2
– 2 – 60601-2-44 © IEC:2009
CONTENTS
FOREWORD.3
201.1 Scope, object and related standards.5
201.2 Normative references .7
201.3 Terms and definitions .7
201.4 General requirements.12
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.14
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 .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.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.24
203 General requirements for RADIATION protection in diagnostic X-ray equipment .24
Annexes .39
Annex AA (informative) Choosing LOADING FACTORS for tests .39
Annex BB (informative) Estimating CTDI for scan projection RADIOGRAPHY (SPR) .40
vol
Bibliography.41
Index of defined terms used in this particular standard.42
Figure 201.101 – Coordinate system.9
Figure 203.101 – Zone of extra-focal RADIATION .29
Figure 203.102 – Minimum dimensions for STRAY RADIATION measurement.32
Table 203.101 − Test pattern for CTDI .36
free air
60601-2-44 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
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 60601-2-44 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 and its
Amendment 1 (2002). This edition constitutes a technical revision primarily related to
RADIATION protection and control.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/727/FDIS 62B/734/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.
– 4 – 60601-2-44 © IEC:2009
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.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
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 perm
...
IEC 60601-2-44 ®
Edition 3.2 2016-03
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de tomodensitométrie
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 20 000 terms and definitions in
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documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
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variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
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CISPR.
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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.
A propos des publications IEC
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IEC 60601-2-44 ®
Edition 3.2 2016-03
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les
performances essentielles des équipements à rayonnement X de
tomodensitométrie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-3290-3
IEC 60601-2-44 ®
Edition 3.2 2016-03
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de tomodensitométrie
– 2 – IEC 60601-2-44:2009+AMD1:2012
+AMD2:2016 CSV IEC 2016
CONTENTS
FOREWORD. 4
Introduction to Amendment 1 . 7
Introduction to Amendment 2 . 8
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 12
201.4 General requirements . 20
201.5 General requirements for testing of ME EQUIPMENT . 21
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 21
201.7 ME EQUIPMENT identification, marking and documents . 22
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 24
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 27
201.10 Protection against unwanted and excessive RADIATION HAZARDS . 30
201.11 Protection against excessive temperatures and other HAZARDS . 31
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 31
201.13 Hazardous situations and fault conditions . 32
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 32
201.15 Construction of ME EQUIPMENT . 32
201.16 ME SYSTEMS . 32
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 32
201.101 Requirements for CT SCANNERS providing images for RADIOTHERAPY
TREATMENT PLANNING (RTP) . 32
202 Electromagnetic compatibility – Requirements and tests . 38
203 General requirements for RADIATION protection in diagnostic X-ray equipment . 38
Annexes . 56
Annex AA (informative) Choosing LOADING FACTORS for tests . 56
)
Annex BB (informative) Estimating CTDI for scan projection RADIOGRAPHY (SPR) . 57
vol
Annex CC (informative) The CTDI concept in IEC 60601-2-44: Relationship
between CTDI and CTDI . 58
100 ∞
Annex DD (informative) Measuring CTDI . 62
free air
Bibliography . 64
Index of defined terms used in this particular standard . 66
Figure 201.101 – Coordinate system . 14
Figure 201.102 – Illustration of N × T, R and (N × T) + R. 17
Figure 201.103 – Vertical alignment of the PATIENT SUPPORT . 33
Figure 201.104 – Z-axis alignment of the PATIENT SUPPORT in the horizontal plane . 35
Figure 203.101 – Zone of extra-focal RADIATION . 44
Figure 203.102 – Minimum dimensions for STRAY RADIATION measurement . 47
Figure CC.1 – CTDI versus beam width along z . 59
w
+AMD2:2016 CSV IEC 2016
Table 203.101 − Test pattern for CTDIfree air . 52
Table CC.1 – Ratios of CTDI by phantom length . 61
– 4 – IEC 60601-2-44:2009+AMD1:2012
+AMD2:2016 CSV IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
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
...
IEC 60601-2-44 ®
Edition 3.1 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de tomodensitométrie
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 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.
Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
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IEC 60601-2-44 ®
Edition 3.1 2012-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-44: Particular requirements for the basic safety and essential performance
of X-ray equipment for computed tomography
Appareils électromédicaux –
Partie 2-44: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de tomodensitométrie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX CT
ICS 11.040.50 ISBN 978-2-8322-0346-0
– 2 – 60601-2-44 IEC:2009+A1:2012
CONTENTS
FOREWORD . 3
Introduction to Amendment 1 . 5
201.1 Scope, object and related standards. 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 17
201.5 General requirements for testing of ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive RADIATION HAZARDS . 27
201.11 Protection against excessive temperatures and other HAZARDS . 28
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 Hazardous situations and fault conditions . 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS. 29
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 29
202 Electromagnetic compatibility – Requirements and tests . 35
203 General requirements for RADIATION protection in diagnostic X-ray equipment . 35
Annexes . 52
Annex AA (informative) Choosing LOADING FACTORS for tests . 52
Annex BB (informative) Estimating CTDI for scan projection RADIOGRAPHY (SPR) . 53
vol
Annex CC (informative) The CTDI concept in IEC 60601-2-44: Relationship
between CTDI and CTDI . 54
100 ∞
Annex DD (informative) Measuring CTDI . 58
free air
Bibliography . 60
Index of defined terms used in this particular standard. 62
Figure 201.101 – Coordinate system . 11
Figure 201.102 – Illustration of N × T, R and (N × T) + R . 14
Figure 201.103 – Vertical alignment of the PATIENT SUPPORT . 30
Figure 201.104 – Z-axis alignment of the PATIENT SUPPORT in the horizontal plane . 32
Figure 203.101 – Zone of extra-focal RADIATION . 41
Figure 203.102 – Minimum dimensions for STRAY RADIATION measurement . 43
Figure CC.1 – CTDI versus beam width along z . 55
w
Table 203.101 − Test pattern for CTDI . 48
free air
Table CC.1 – Ratios of CTDI by phantom length . 57
60601-2-44 IEC:2009+A1:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
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 IEC 60601-2-44 consists of the third edition (2009)
[documents 62B/727/FDIS and 62B/734/RVD], its amendment 1 (2012) [documents
62B/879/FDIS and 62B/890/RVD] and its corrigendum of May 2010. It bears the edition
number 3.1.
The technical content is therefore identical to the base edition and its amendment and
has been prepared for user convenience. A vertical line in the margin shows where the
base publication has been modified by amendment 1. Additions and deletions are
displayed in red, with deletions being struck through.
– 4 – 60601-2-44 IEC:2009+A1:2012
International standard IEC 60601-2-44 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are
...
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