Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy.

Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie

La CEI 60601-2-54:2009 s'applique à la sécurité de base et aux performances essentielles des appareils electromédicaux et des systèmes electromédicaux destinés à la radiographie de projection et à la radioscopie. Les exigences de sécurité minimales spécifiées dans la présente norme particulière sont estimées assurer un degré de sécurité réalisable dans le cadre du fonctionnement des appareils EM utilisés pour la radiographie et la radioscopie. Des dispositions supplémentaires concernant les procédures d'intervention applicables aux appareils EM sont spécifiées dans la CEI 60601-2-43. La CEI 60601-2-54:2009 a été élaborée en vue d'une utilisation avec la troisième édition de la CEI 60601-1 (2005) et ses normes collatérales. Le contenu des corrigendum de mars 2010 et juin 2011 a été pris en considération dans cet exemplaire.

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IEC 60601-2-54 ®
Edition 1.0 2009-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
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
3, rue de Varembé
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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 60601-2-54 ®
Edition 1.0 2009-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.50 ISBN 978-2-88910-227-3
– 2 – 60601-2-54 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
201.1 Scope, object and related standards .7
201.2 Normative references.8
201.3 Terms and definitions.9
201.4 General requirements .10
201.5 General requirements for testing of ME EQUIPMENT .11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS.11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .17
201.10 Protection against unwanted and excessive radiation HAZARDS .21
201.11 Protection against excessive temperatures and other HAZARDS .21
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 .22
202 Electromagnetic compatibility – Requirements and tests .22
203 Radiation protection in diagnostic X-ray equipment.23
Annexes .58
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.59
Annex AA (informative) Particular guidance and rationale.61
Bibliography.64
Index of defined terms used in this particular standard.65

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION .41
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA.43
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD .47
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) .55
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) .55
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) .56
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT).57

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements .10
Table 203.101 – Tests for verifying reproducibility and linearity .29

60601-2-54 © IEC:2009 – 3 –
Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS.31
Table 203.103 – ATTENUATION for the measurement of AIR KERMA .33
Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM.49
Table 203.105 – Application categories .51
Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING .51
Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY .53
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts .59
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS.59

– 4 – 60601-2-54 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy

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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 60601-2-54 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
IEC 60601-2-54 has been developed for
...


IEC 60601-2-54 ®
Edition 1.1 2015-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
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.
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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.

A propos des publications IEC
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IEC 60601-2-54 ®
Edition 1.1 2015-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-54: Particular requirements for the basic safety and essential

performance of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils à rayonnement X utilisés pour la

radiographie et la radioscopie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2619-3

IEC 60601-2-54 ®
Edition 1.1 2015-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
– 2 – IEC 60601-2-54:2009
+AMD1:2015 CSV  IEC 2015
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 7

201.1 Scope, object and related standards. 8

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 . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
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 . 23
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
202 Electromagnetic compatibility – Requirements and tests . 24
203 Radiation protection in diagnostic X-ray equipment . 24
Annexes . 60
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 61
Annex AA (informative) Particular guidance and rationale . 63
Bibliography . 66
Index of defined terms used in this particular standard. 67

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 43
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 45
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 49
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 57
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 57
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 58
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 59

Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 11

+AMD1:2015 CSV  IEC 2015
Table 203.101 – Tests for verifying reproducibility and linearity . 31

Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS . 33

Table 203.103 – ATTENUATION for the measurement of AIR KERMA . 35

Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 51

Table 203.105 – Application categories . 53

Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 53

Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 55

Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 61

Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 61

– 4 – IEC 60601-2-54:2009
+AMD1:2015 CSV  IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION

_____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-54: Particular requirements for the basic safety and essential

performance of X-ray equipment for radiography and radioscopy

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 Organizati
...


IEC 60601-2-54 ®
Edition 1.2 2018-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
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 info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
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IEC 60601-2-54 ®
Edition 1.2 2018-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-54: Particular requirements for the basic safety and essential performance

of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X utilisés pour la radiographie et la

radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-5862-0

IEC 60601-2-54 ®
Edition 1.2 2018-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy

Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
– 2 – IEC 60601-2-54:2009+AMD1:2015

+AMD2:2018 CSV  IEC 2018
CONTENTS
FOREWORD. 4

INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 7

INTRODUCTION TO AMENDMENT 2 . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 9

201.3 Terms and definitions . 10
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 . 13
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 . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic compatibility – Requirements and tests . 25
203 Radiation protection in diagnostic X-ray equipment . 25
Annexes . 65
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 66
Annex AA (informative) Particular guidance and rationale . 68
Bibliography . 73

Index of defined terms used in this particular standard . 75

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 47
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 49
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 53
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 62
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 62
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 63
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 64

+AMD2:2018 CSV  IEC 2018
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 12

Table 203.101 – Tests for verifying reproducibility and linearity. 33

Table 203.102 – Loadings for testing AUTOMATIC EXPOSURE CONTROLS . 35

Table 203.103 – ATTENUATION for the measurement of AIR KERMA . 37

Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 55

Table 203.105 – Application categories . 57

Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 58

Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 60

Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 66
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 66

– 4 – IEC 60601-2-54:2009+AMD1:2015

+AMD2:2018 CSV  IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION

_____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-54: Particular requirements for the basic safety and essential

performance of X-ray equipment for radiography and radioscopy

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 part
...

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