SIST EN IEC 60601-2-54:2024

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-54. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za radiografijo in radioskopijo (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)
Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie
und Radioskopie (IEC 60601-2-54:2022)
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)
Ta slovenski standard je istoveten z: EN IEC 60601-2-54:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-54

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.040.50 Supersedes EN 60601-2-54:2009; EN 60601-2-
54:2009/A1:2015; EN 60601-2-54:2009/A2:2019
English Version
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)
Appareils électromédicaux - Partie 2-54: Exigences Medizinische elektrische Geräte - Teil 2-54: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und die wesentlichen
essentielles des appareils à rayonnement X utilisés pour la Leistungsmerkmale von Röntgeneinrichtungen für
radiographie et la radioscopie Radiographie und Radioskopie
(IEC 60601-2-54:2022) (IEC 60601-2-54:2022)
This European Standard was approved by CENELEC on 2024-07-31. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-54:2024 E

European foreword
The text of document 62B/1285/FDIS, future edition 2 of IEC 60601-2-54, prepared by SC 62B
"Medical imaging equipment, software, and systems" of IEC/TC 62 "Medical equipment, software, and
systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
document have to be withdrawn
This document supersedes EN 60601-2-54:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-54:2022 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60627 NOTE Approved as EN 60627
IEC 61267:2005 NOTE Approved as EN 61267:2006 (not modified)
ISO 4090:2001 NOTE Approved as EN ISO 4090:2004 (not modified)
IEC 60601-2-28:2017 NOTE Approved as EN IEC 60601-2-28:2019 (not modified)
IEC 60601-1-8 NOTE Approved as EN 60601-1-8
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 60601-1-11:2015 NOTE Approved as EN 60601-1-11:2015 (not modified)
IEC 60601-1-11:2015/A1:2020 NOTE Approved as EN 60601-1-11:2015/A1:2021 (not modified)
IEC 60601-1-12:2014 NOTE Approved as EN 60601-1-12:2015 (not modified)
IEC 60601-1-12:2014/A1:2020 NOTE Approved as EN 60601-1-12:2015/A1:2020 (not modified)
IEC 60601-2-43:2010 NOTE Approved as EN 60601-2-43:2010 (not modified)
IEC 60601-2-43:2010/A1:2017 NOTE Approved as EN 60601-2-43:2010/A1:2018 (not modified)
IEC 60601-2-43:2010/A2:2019 NOTE Approved as EN 60601-2-43:2010/A2:2020 (not modified)
IEC 62563-1:2009 NOTE Approved as EN 62563-1:2010 (not modified)
IEC 62563-1:2009/A1:2016 NOTE Approved as EN 62563-1:2010/A1:2016 (not modified)
IEC 62563-1:2009/AMD2:2021 NOTE Approved as EN 62563-1:2010/A2:2021 (not modified)
IEC 60601-1-9 NOTE Approved as EN 60601-1-9
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) +A11:2021
IEC 62220-1-1:2015 NOTE Approved as EN 62220-1-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60336 2020 Medical electrical equipment - X-ray tube EN IEC 60336 2021
assemblies for medical diagnosis - Focal
spot dimensions and related characteristics
IEC 60580 2019 Medical electrical equipment - Dose area EN IEC 60580 2020
product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
+ AC 2014
- -
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60806 - Determination of the maximum symmetrical EN IEC 60806 -
radiation field of X-ray tube assemblies and
X-ray source assemblies for medical
diagnosis
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
IEC 61910-1 2014 Medical electrical equipment - Radiation EN 61910-1 2014
dose documentation - Part 1: Radiation
dose structured reports for radiography and
radioscopy
IEC 62494-1 2008 Medical electrical equipment - Exposure EN 62494-1 2008
index of digital X-ray imaging systems -
Part 1: Definitions and requirements for
general radiography
Replace:
Publication Year Title EN/HD Year
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + AC 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
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

IEC 60601-2-54:2022 © IEC 2022 – 3 –
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
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.
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. 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;
IEC 60601-2-54:2022 © IEC 2022 – 5 –
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;
ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the
f) explanation of the term
performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS.
The text of this document is based on the following documents:
Draft Report on voting
62B/1285/FDIS 62B/1293/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND IEC
60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, 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 document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this document are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
– 6 – IEC 60601-2-54:2022 © IEC 2022
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 and IEC 80601 series, published under the general title
Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IEC 60601-2-54:2022 © IEC 2022 – 7 –
INTRODUCTION
This document has been prepared to provide, based on IEC 60601-1:2005 (third edition) and
its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and
RADIOSCOPY. The purpose of this second edition is to introduce changes to reference the second
amendment (2020) to IEC 60601-1:2005 and associated collateral standards. Moreover, in
Annex AA a clarification of the term for ESSENTIAL PERFORMANCE is provided. This document
addresses the system level of X-RAY EQUIPMENT, which consists of a combination of an X-RAY
GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component functions are addressed as
far as necessary.
The minimum safety requirements specified in this document 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.
– 8 – IEC 60601-2-54:2022 © IEC 2022
MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document 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.
201.1.2 Object
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE
The object of this document is to establish particular
requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 as
modified in 201.2.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply, as modified in
Clauses 202 and 203 respectively. If the MANUFACTURER declares that the ME EQUIPMENT or ME
SYSTEM is intended to be operated in a HOME HEALTHCARE ENVIRONMENT, then
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply and if the MANUFACTURER
declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in an EMERGENCY
MEDICAL SERVICES ENVIRONMENT, then IEC 60601-1-12:2014 and
IEC 60601-1-12:2015/AMD1:2020 apply. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 do
not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
NOTE 1 OPERATORS of X-RAY EQUIPMENT are used to audible signals as specified in this document rather than to
the concepts of IEC 60601-1-8. Therefore IEC 60601-1-8 does not apply.

IEC 60601-2-54:2022 © IEC 2022 – 9 –
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 and collateral standards as appropriate for the particular ME EQUIPMENT
under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or
applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC
60601-1:2005/AMD2:2020 or the applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.

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201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
Addition:
IEC 60336:2020, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Focal spot dimensions and related characteristics
IEC 60580:2019, Medical electrical equipment – Dose area product meters
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 60806, Determination of the maximum symmetrical radiation field of X-ray tube assemblies
and X-ray source assemblies for medical diagnosis
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62494-1:2008, Medical electrical equipment – Exposure index of digital X-ray imaging
systems – Part 1: Definitions and requirements for general radiography
Amendment:
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-ray
equipment
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC TR 60788:2004 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An Index of defined terms is found in the last part of this document.

IEC 60601-2-54:2022 © IEC 2022 – 11 –
Addition:
201.3.201
APPARENT RESISTANCE OF SUPPLY MAINS
for diagnostic X-RAY GENERATOR, resistance of the SUPPLY MAINS determined under specific load
conditions
201.3.202
AUTOMATIC INTENSITY CONTROL
in an X-RAY GENERATOR, mode of operation in which one or more LOADING FACTORS are controlled
automatically in order to obtain at a pre-selected location a desired rate of a RADIATION QUANTITY
201.3.203
DIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected at an IMAGE RECEPTION AREA
Example: Film-screen or film RADIOGRAPHY.
201.3.204
DIRECT RADIOSCOPY
RADIOSCOPY in which the visible images are presented at the IMAGE RECEPTION AREA, or close to
it, in the RADIATION BEAM
201.3.205
DOSE AREA PRODUCT
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that
cross-section. The unit is the gray square metre (Gy⋅m )
Note 1 to entry: This definition is equivalent to AIR KERMA area product.
201.3.206
DOSIMETER
EQUIPMENT which uses ionization chambers or semiconductor detectors for the measurement of
AIR KERMA or AIR KERMA RATE in the beam of an X-RAY EQUIPMENT used for diagnostic medical
RADIOLOGICAL examinations
201.3.207
ENTRANCE FIELD SIZE
dimensions of the field in the entrance plane of an X-RAY IMAGE RECEPTOR that can be used for
the transmission of an X-RAY PATTERN under specific conditions
201.3.208
EXAMINATION PROTOCOL
full set of any programmed technical factors, control functions and settings, including image
processing settings, designed to optimize the image acquisition and DISPLAY
201.3.209
EXAMINATION PROTOCOL SELECTION CONTROL
control to select a PRE-PROGRAMMED EXAMINATION PROTOCOL
201.3.210
HIGH-VOLTAGE GENERATOR
in an X-RAY GENERATOR, combination of all components for control and production of the
electrical energy to be supplied to an X-RAY TUBE, usually consisting of a high-voltage
transformer assembly and a control assembly
201.3.211
IMAGE RECEPTION PLANE
plane containing the greatest dimensions of the IMAGE RECEPTION AREA

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201.3.212
INDIRECT RADIOGRAPHY
RADIOGRAPHY in which the permanent recording is effected after TRANSFER of the information
obtained at an IMAGE RECEPTION AREA
Examples: CR systems, digital detector systems, image intensifier systems.
201.3.213
INDIRECT RADIOSCOPY
RADIOSCOPY in which the images are presented at a location outside the RADIATION BEAM after
TRANSFER of the information
201.3.214
INTERLOCK
means preventing the start or the continued operation of ME EQUIPMENT unless certain
predetermined conditions prevail
201.3.215
ISOCENTRE
in RADIOLOGICAL equipment with several modes of movement of the REFERENCE AXIS around a
common centre, centre of the smallest sphere through which the X-RAY BEAM AXIS passes
201.3.216
LAST IMAGE HOLD RADIOGRAM
LIH RADIOGRAM
single image obtained by sampling or temporal processing of one or more images from the end
of a radioscopic IRRADIATION
Note 1 to entry: This note applies to the French language only.
201.3.217
NOMINAL ELECTRIC POWER
for a HIGH-VOLTAGE GENERATOR, highest constant electric power which can be delivered for a
single X-RAY TUBE load in a specific LOADING TIME
201.3.218
NOMINAL SHORTEST IRRADIATION TIME
shortest LOADING TIME for which a required constancy of the controlled radiation quantity is
maintained
Note 1 to entry: The IRRADIATION TIME is controlled by a HIGH-VOLTAGE GENERATOR with AUTOMATIC CONTROL
SYSTEMS.
201.3.219
PRE-PROGRAMMED EXAMINATION PROTOCOL
single hardware or software setting, or both, which is associated with an EXAMINATION PROTOCOL
201.3.220
QUALITY CONTROL
operational techniques and activities that are used to fulfil requirements for quality
201.3.221
RADIATION OUTPUT
AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in
the primary X-RAY BEAM
201.3.222
RADIOSCOPY REPLAY IMAGE SEQUENCE
series of the most recent images of the most recent RADIOSCOPY IRRADIATION-EVENT

IEC 60601-2-54:2022 © IEC 2022 – 13 –
201.3.223
REGION OF INTEREST
localized part of an image, which is of particular interest at a given time
201.3.224
SERIAL RADIOGRAPHY
RADIOGRAPHY in which the information is obtained and recorded in a regular or irregular series
of LOADINGS with equal or unequal LOADING FACTORS
201.3.225
SIX-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with six peaks during each cycle of the supply
201.3.226
TIMING DEVICE
device integrating and/or presenting time elapsed during an equipment function and optionally
changing the state of operation at the end of a predetermined time interval
201.3.227
TWELVE-PEAK HIGH-VOLTAGE GENERATOR
HIGH-VOLTAGE GENERATOR for operation on a three-phase supply that delivers a rectified output
voltage with twelve peaks during each cycle of the supply
201.3.228
X-RAY BEAM AXIS
for a symmetrical RADIATION BEAM, line through the centre of the RADIATION SOURCE and half way
between the effective edges of the BEAM LIMITING DEVICE
Note 1 to entry: Usually, the X-RAY BEAM AXIS coincides within required tolerances with the REFERENCE AXIS of the
RADIATION SOURCE.
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
SSENTIAL PERFORMANCE
201.4.3 E
Additional subclause:
ESSENTIAL PERFORMANCE requirements
201.4.3.101 * Additional potential
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Accuracy of LOADING FACTORS 203.6.4.3.104
Reproducibility of the RADIATION output 203.6.3.2
AUTOMATIC CONTROL SYSTEM 203.6.5
Imaging performance 203.6.7
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201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS
Addition:
The internal impedance of a SUPPLY MAINS shall be considered sufficiently low for the operation
of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY if the value of the APPARENT RESISTANCE
OF SUPPLY MAINS does not exceed the value specified in the ACCOMPANYING DOCUMENTS.
Either the APPARENT RESISTANCE OF SUPPLY MAINS or other appropriate SUPPLY MAINS
specifications used in a facility shall be specified in the ACCOMPANYING DOCUMENTS.
NOTE If a NOMINAL voltage is claimed for a mains power supply system, it is assumed that there is no voltage of a
higher value between any of the conductors of the system or between any of these conductors and earth.
An alternating voltage is considered in practice to be sinusoidal if any instantaneous value of the waveform concerned
differs from the instantaneous value of the ideal waveform at the same moment by no more than ± 2 % of the peak
value of the ideal waveform.
A three-phase SUPPLY MAINS is considered to have a practical symmetry if it delivers symmetrical voltages and
produces, when loaded symmetrically, symmetrical currents.
The requirements of this document are based upon the assumption that three-phase systems have a symmetrical
configuration of the MAINS VOLTAGE with respect to earth. Single-phase systems can be derived from such three-phase
systems. Where the supply system is not earthed at the source it is assumed that adequate measures have been
provided to detect, limit and remedy any disturbance of symmetry within a reasonably short time.
X-RAY EQUIPMENT is considered to comply with the requirements of this document only if its specified NOMINAL
ELECTRIC POWER can be demonstrated at an APPARENT RESISTANCE OF SUPPLY MAINS having a value not less than the
APPARENT RESISTANCE OF SUPPLY MAINS specified by the MANUFACTURER in the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the accompanying documents.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Addition:
For ME EQUIPMENT that is specified to be PERMANENTLY INSTALLED, the information may be stated
in the ACCOMPANYING DOCUMENTS only.
The information on the input power shall be specified in terms of combinations of
a) the RATED MAINS VOLTAGE of the ME EQUIPMENT in volts; see 7.2.1 and 7.2.6 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
...