EN IEC 60601-2-54:2024

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.

Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie

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.

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)

General Information

• Status: Published
• Publication Date: 19-Sep-2024
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-Sep-2024
• Completion Date: 20-Sep-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 60601-2-54:2024 - 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)

Relations

• Replaces: EN 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: 07-Jun-2022
• Replaces: EN 60601-2-54:2009/A2:2019 - 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: 03-Aug-2021
• Replaces: EN 60601-2-54:2009/A1:2015 - 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: 03-Aug-2021

Standards Content (Sample)

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 .
...