IEC 60601-2-43:2022

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-43:2022 is available as IEC 60601-2-43:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-43:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X RAY EQUIPMENT;
- dental X RAY EQUIPMENT.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY 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 INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. 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 as in IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
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 former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE ASSEMBLIES” is removed since covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017, and the former subclause 201.11.102 is renumbered as 201.11.101, as in IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in IEC 60601 1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT, as in IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.

Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d'interventions

IEC 60601-2-43:2022 est disponible sous forme de IEC 60601-2-43:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-43:2022 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS A RAYONNEMENT X FIXES et MOBILES déclarés par leur FABRICANT comme étant adaptés aux INTERVENTIONS GUIDEES PAR RADIOSCOPIE, désignés ci-après par le terme APPAREILS A RAYONNEMENT X D'INTERVENTION. Son domaine d’application exclut en particulier:
- les équipements de RADIOTHERAPIE;
- les équipements de TOMODENSITOMETRIE;
- les ACCESSOIRES destinés à être introduits dans le corps du PATIENT;
- les APPAREILS de mammographie A RAYONNEMENT X;
- les APPAREILS de radiographie dentaire A RAYONNEMENT X.
Les APPAREILS A RAYONNEMENT X D’INTERVENTION déclarés par le FABRICANT comme étant adaptés aux INTERVENTIONS GUIDEES PAR RADIOSCOPIE, qui n’incluent pas le SUPPORT PATIENT sont exemptés des dispositions du présent document applicables au SUPPORT PATIENT.
Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS A RAYONNEMENT X D’INTERVENTION ou uniquement aux SYSTEMES EM, le titre et le contenu de l’article ou du paragraphe concerné l'indiquent. Si tel n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS A RAYONNEMENT X D’INTERVENTION et aux SYSTEMES EM, selon le cas.
L'IEC 60601-2-54 s'applique uniquement en ce qui concerne les paragraphes cités; les paragraphes non cités de l'IEC 60601-2-54 ne s'appliquent pas.
L'IEC 60601-2-43:2022 annule et remplace la deuxième édition parue en 2010, l'Amendement 1:2017 et l'Amendement 2:2019. Cette édition constitue une révision technique.
Cette édition inclut des modifications rédactionnelles et techniques pour refléter les modifications dans l’IEC 60601 1:2005/AMD2:2020 et l’IEC 60601-2-54:2022. Elle contient également des corrections et des améliorations techniques. Les modifications techniques majeures par rapport à l’édition précédente sont les suivantes:
a) un nouveau terme spécifique DOSIMETRE est utilisé pour remplacer le terme général DOSIMETRE comme dans l’IEC 60601-2-54:2022;
b) plusieurs termes et définitions de l’IEC TR 60788:2004 déplacés dans l’Article 201.3 de l’IEC 60601-2-54:2022 sont aussi référencés à partir de l’IEC 60601-2-54:2022;
c) 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 sont applicables lorsque le FABRICANT les déclare telles quelles;
d) l’ancien paragraphe 201.11.101 "Protection contre les températures excessives des GAINES EQUIPEES" est supprimé car il est couvert 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 et l’ancien paragraphe 201.11.102 est renuméroté en 201.11.101, comme dans l’IEC 60601-2-54:2022;
e) pour adopter les modifications du paragraphe 7.8.1 "Couleurs des voyants lumineux" de l’IEC 60601-1:2005/AMD2:2020, une clarification des exigences est fournie en 201.7.8.1 pour éviter les contradictions avec les exigences des voyants lumineux stipulées pour les APPAREILS A RAYONNEMENT X, comme dans l’IEC 60601-2-54:2022;
f) une explication du terme PERFORMANCE ESSENTIELLE est donnée à l’Annexe AA pour mettre l’accent sur les performances de la fonction clinique dans les CONDITIONS NORMALES et les CONDITIONS DE PREMIER DEFAUT.

General Information

• Status: Published
• Publication Date: 04-Dec-2022
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 41 - TC 62/SC 62B/MT 41
• Current Stage: PPUB - Publication issued
• Start Date: 23-Dec-2022
• Completion Date: 05-Dec-2022

Relations

• Revises: IEC 60601-2-43:2010/AMD2:2019 - Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-43:2010/AMD1:2017 - Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-43:2010 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-43 ®
Edition 3.0 2022-12
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures

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]
3, rue de Varembé [e-mail]
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
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IEC 60601-2-43 ®
Edition 3.0 2022-12
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50; 37.040.25 ISBN 978-2-8322-6213-9

– 2 – IEC 60601-2-43:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 8
201.2 Normative references . 11
201.3 Terms and definitions. 12
201.4 General requirements . 13
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 . 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
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 . 24
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 disturbances – Requirements and tests . 29
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT . 29
Annexes . 42
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (normative) Distribution maps of STRAY RADIATION . 55
Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43
and Edition 1 .
Bibliography . 60
Index of defined terms . 63

Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration . 56
Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration . 57

Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
by the MANUFACTURER in the RISK MANAGEMENT analysis . 13
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS . 20
Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES for which deterministic effects of IRRADIATION are possible . 43
Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
which deterministic effects are unlikely . 44
Table AA.3 – Examples of isodose boundaries and colour codes for SKIN DOSE MAP and
AIR KERMA map . 53

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures

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
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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
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes made to
the previous edition IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV. A vertical bar appears
in the margin wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
– 4 – IEC 60601-2-43:2022 RLV © IEC 2022
IEC 60601-2-43 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 third edition cancels and replaces the second edition published in 2010,
Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the changes in
IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. 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 as in
IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of
IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
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 former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE
ASSEMBLIES” is removed since covered by IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017,
and the former subclause 201.11.102 is renumbered as 201.11.101, as in
IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in
IEC 60601-1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to
RAY EQUIPMENT, as in
avoid conflicts with requirements of indicator lights stipulated for X-
IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the
performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.
The text of this International Standard is based on the following documents:
Draft Report on voting
62B/1297/FDIS 62B/1309/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 numbe
...

IEC 60601-2-43 ®
Edition 3.0 2022-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures

Appareils électromédicaux –
Partie 2-43: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X lors d’interventions

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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About the IEC
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International Standards for all electrical, electronic and related technologies.

About IEC publications
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IEC 60601-2-43 ®
Edition 3.0 2022-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-43: Particular requirements for the basic safety and essential performance

of X-ray equipment for interventional procedures

Appareils électromédicaux –
Partie 2-43: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à rayonnement X lors d’interventions

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50; 37.040.25 ISBN 978-2-8322-6087-6

– 2 – IEC 60601-2-43:2022 © IEC 2022
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 11
201.5 General requirements for testing 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 . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic disturbances – Requirements and tests . 26
203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT . 26
Annexes . 39
Annex AA (informative) Particular guidance and rationale . 40
Annex BB (normative) Distribution maps of STRAY RADIATION . 52
Bibliography . 55
Index of defined terms . 58

Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration . 53
Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration . 54

Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
by the MANUFACTURER in the RISK MANAGEMENT analysis . 11
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS . 17
Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES for which deterministic effects of IRRADIATION are possible . 40
Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
which deterministic effects are unlikely . 41
Table AA.3 – Examples of isodose boundaries and colour codes for SKIN DOSE MAP and
AIR KERMA map . 50

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures

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
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IEC 60601-2-43 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 third edition cancels and replaces the second edition published in 2010,
Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the changes in
IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. 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 as in
IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2
...