IEC 60601-2-54:2022

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

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3;
c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017;
e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

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

IEC 60601-2-54:2022 est disponible sous forme de IEC 60601-2-54:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-54:2022 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et des SYSTEMES EM destinés à la RADIOGRAPHIE de projection et à la RADIOSCOPIE INDIRECTE. L’IEC 60601-2-43 est applicable aux APPAREILS EM et aux SYSTEMES EM destinés à être utilisés lors de procédures d’interventions et se réfère aux exigences applicables du présent document. Les APPAREILS EM et SYSTEMES EM destinés à l’ostéodensitométrie par absorption, à la tomodensitométrie, à la mammographie ou aux applications dentaires ou de radiothérapie, sont exclus du domaine d’application du présent document. Le domaine d’application du présent document exclut également les simulateurs de radiothérapie. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, son titre et son contenu l’indiquent. Lorsque cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. L'IEC 60601-2-54:2022 nnule et remplace la première édition parue en 2009, l'Amendement 1:2015 et l'Amendement 2:2018. Cette édition constitue une révision technique. La présente édition comprend des modifications techniques et rédactionnelles destinées à représenter l’IEC 60601 1:2005/AMD2:2020. Elle contient également des corrections et des améliorations techniques. Les modifications techniques majeures par rapport à l’édition précédente sont les suivantes:
a) déplacement en 201.3 des termes issus exclusivement de l’IEC TR 60788:2004 et qui sont spécifiquement applicables dans le présent document;
b) si le FABRICANT le déclare, les normes collatérales IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 et IEC 60601-1-12:2014/AMD1:2020 s'appliquent;
c) le paragraphe 201.11.101 “Protection contre les températures excessives des gaines équipées” a été supprimé du présent document, car ses exigences sont suffisamment et clairement traitées par l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012, l’IEC 60601-1:2005/AMD2:2020 et l’IEC 60601-2-28:2017;
d) clarification des exigences pour l’adoption des modifications introduites concernant les voyants lumineux au paragraphe 7.8.1 de l’IEC 60601-1:2005/AMD2:2020 afin d’éviter les conflits avec les exigences relatives aux voyants lumineux stipulées pour les APPAREILS A RAYONNEMENT X;
e) explication du terme PERFORMANCE ESSENTIELLE fournie dans l’Annexe AA afin de mettre l’accent sur la fonction clinique en CONDITION NORMALE ET DE PREMIER DEFAUT.

General Information

• Status: Published
• Publication Date: 25-Sep-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 37 - TC 62/SC 62B/WG 37
• Current Stage: PPUB - Publication issued
• Start Date: 23-Sep-2022
• Completion Date: 26-Sep-2022

Relations

• Revises: IEC 60601-2-54:2009/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-54:2009/AMD1:2015 - Amendment 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-54:2009/COR1:2010 - Corrigendum 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-54:2009/COR2:2011 - Corrigendum 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-54 ®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
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

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.

IEC Secretariat Tel.: [phone]
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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.

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IEC 60601-2-54 ®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-5784-5

– 2 – IEC 60601-2-54:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
INTRODUCTION TO AMENDMENT 1 .
INTRODUCTION TO AMENDMENT 2 .
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 26
201.11 Protection against excessive temperatures and other HAZARDS . 26
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 28
201.16 ME SYSTEMS . 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
202 Electromagnetic compatibility disturbances – Requirements and tests . 28
202.101 * Immunity testing of ESSENTIAL PERFORMANCE . 28
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT. 29
203.4 General requirements . 29
203.5 ME EQUIPMENT identification, marking and documents . 30
203.6 RADIATION management . 33
203.7 RADIATION QUALITY . 48
203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY
FIELD and IMAGE RECEPTION AREA . 49
203.9 FOCAL SPOT TO SKIN DISTANCE . 57
203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 58
203.11 Protection against RESIDUAL RADIATION . 59
203.12 Protection against LEAKAGE RADIATION . 61
203.13 Protection against STRAY RADIATION . 61
Annexes . 67
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 68
Annex AA (informative) Particular guidance and rationale . 70
Bibliography . 75

Index of defined terms used in this document . 78

Figure 203.101 – Zone of EXTRA-FOCAL RADIATION . 50
Figure 203.102 – Discrepancies in covering the IMAGE RECEPTION AREA . 52
Figure 203.103 – Discrepancies in visual indication of the X-RAY FIELD . 56
Figure 203.104 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY below the PATIENT SUPPORT) . 64
Figure 203.105 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY below the PATIENT SUPPORT) . 65
Figure 203.106 – Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY
SOURCE ASSEMBLY above the PATIENT SUPPORT) . 65
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 66

Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 15
Table 203.101 – Tests for verifying reproducibility and linearity . 37
Table 203.102 – LOADINGS for testing automatic exposure controls . 38
Table 203.103 – ATTENUATION for the measurement of AIR KERMA. 40
Table 203.104 – ATTENUATION EQUIVALENT of items in the X-RAY BEAM . 58
Table 203.105 – Application categories. 60
Table 203.106 – Requirements for PRIMARY PROTECTIVE SHIELDING . 61
Table 203.107 – STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY . 63
Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts . 68
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 68

– 4 – IEC 60601-2-54:2022 RLV © IEC 2022
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.
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes made to
the previous edition IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 CSV. A vertical bar appears
in the margin wherever a change has been made. Additions are in green text, deletions are in
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IEC 60601-2-54 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice. It is an International
Standard.
This second edition cancels and replaces the first edition published in 2009, Amendment 1:2015
and Amendment 2:2018. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the
IEC 60601-1:2005/AMD2:2020
...

IEC 60601-2-54 ®
Edition 2.0 2022-09
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
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International Standards for all electrical, electronic and related technologies.

About IEC publications
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latest edition, a corrigendum or an amendment might have been published.

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IEC 60601-2-54 ®
Edition 2.0 2022-09
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
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-5592-6

– 2 – IEC 60601-2-54:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
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 . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 26
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 26
202 Electromagnetic disturbances – Requirements and tests . 26
202.101 * Immunity testing of ESSENTIAL PERFORMANCE . 26
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT. 26
203.4 General requirements . 27
203.5 ME EQUIPMENT identification, marking and documents . 28
203.6 RADIATION management . 31
203.7 RADIATION QUALITY . 46
203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY
FIELD and IMAGE RECEPTION AREA . 47
203.9 FOCAL SPOT TO SKIN DISTANCE . 54
203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 55
203.11 Protection against RESIDUAL RADIATION . 56
203.12 Protection against LEAKAGE RADIATION . 58
203.13 Protection against STRAY RADIATION . 58
Annexes . 64
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 65
Annex AA (informative) Particular guidance and rationale . 67
Bibliography . 72
Index of defined terms used in this document . 74

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) . 61
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) . 62
Figure 203.107 – Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE
ASSEMBLY above the PATIENT SUPPORT) . 63

Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements . 13
Table 203.101 – Tests for verifying reproducibility and linearity . 34
Table 203.102 – LOADINGS for testing automatic exposure controls . 36
Table 203.103 – ATTENUATION for the measurement of AIR KERMA. 38
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 . 65
Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 66

– 4 – IEC 60601-2-54:2022 © IEC 2022
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
...