IEC 60601-2-43:2022
(Main)Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
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 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
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.
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IEC 60601-2-43 ®
Edition 3.0 2022-12
REDLINE VERSION
INTERNATIONAL
STANDARD
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Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures
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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
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6) All users should ensure that they have the latest edition of this publication.
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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 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.
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.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.
– 6 – IEC 60601-2-43:2022 RLV © IEC 2022
INTRODUCTION
The purpose of this new edition is to introduce changes to reference the Amendment 2 (2020)
to IEC 60601-1:2005 and some minor technical clarifications.
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may can subject
PATIENTS and OPERATORS to higher levels of RADIATION than those which normally prevail during
diagnostic X-ray imaging procedures. One consequence for the PATIENT may can be the
occurrence of deterministic injury when RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
involve the delivery of substantial amounts of RADIATION to localized areas. Another
consequence can be an increased RISK of stochastic effects, such as cancer. These health
concerns apply also to the OPERATOR. In addition, for this particular type of equipment, there is
a need for availability of critical functions with minimal periods of loss.
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES of the type envisaged are well
established in clinical fields such as:
– invasive cardiology;
– interventional RADIOLOGY;
– interventional neuroradiology.
These RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES also include many newly
developing and emerging applications in a wide range of medical and surgical specialties.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
which may sometimes do not align with the provisions of this document.
INTRODUCTION to Amendment 1
The purpose of this first amendment to IEC 60601-2-43:2010 is to introduce changes as follows:
– refer to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its applicable collateral
standards;
– refer to IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 and consequent
subclause adaptations;
– include a requirement to have a maximum time of 10 min to recover all functions after a
recoverable failure in 201.4.101;
– include several aspects from IEC 61910-1:2014 and remove the reference to
IEC PAS 61910-1:2007 in 201.4.102;
– include an alternative way of testing in 201.11.6.5.103;
– include a clarification for tableside controls in 201.12.4.106.
In addition, a number of technical errors have been corrected.
INTRODUCTION to Amendment 2
The purpose of this second amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– scope clarification with regards to MOBILE X-ray equipment and applicability of IEC 60601-2-
54 subclauses;
– reference to IEC 60601-2-54:2009/AMD2:2018 for common subclauses;
– alignment of 201.7.9.1 with IEC 60601-2-54:2009/AMD2:2018 – 201.7.9.1 is no longer
modified;
– inclusion of adapted requirements or recommendations from
IEC 60601-2-54:2009/AMD2:2018 for
• management of radioscopy image storage in 203.6.1.101,
• display of last image hold (LIH RADIOGRAM) in 203.6.7.101, and
• graphical indication of the boundaries of the X-RAY FIELD in 203.8.102.2;
– inclusion of a recommendation for protection of gantry enclosures in 201.11.6.5.103;
– inclusion of a requirement for X-RADIATION pulse repetition frequency during radioscopy
in 203.6.3.103;
– inclusion of a recommendation for a DOSE MAP in 203.6.4.5 with additional definitions
in 201.3;
– inclusion of a requirement for display unit of dose area product in 203.6.4.5;
– addition of a number of technical clarifications.
– 8 – IEC 60601-2-43:2022 RLV © IEC 2022
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures
201.1 Scope, object and related standards
1 )
Clause 1 of the general standard 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 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.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL
X-RAY EQUIPMENT complying with this document is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT
in an operating room environment were not considered in this document; therefore, no specific requirements have
been developed for these devices or uses. In any case, such devices or uses remain under the general clause
requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this document and
not by IEC 60601-2-44 [1] . No additional requirements for operation in cone-beam CT mode were identified for this
document (see also Note 5 in 203.6.4.5).
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.
INTERVENTIONAL X-RAY
If a clause or subclause is specifically intended to be applicable to
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.
NOTE 4 See also 4.2 of the general standard.
___________
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
Numbers in square brackets refer to the Bibliography.
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54
applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do
not apply.
201.1.2 Object
Replacement:
The object of this document is:
– to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the
design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES, as defined in 201.3.205.
– to specify information which is to shall be provided with such INTERVENTIONAL X-RAY
EQUIPMENT for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing
the RADIATION RISK and equipment failure RISK arising from these RADIOSCOPICALLY GUIDED
INTERVENTIONAL PROCEDURES which could affect PATIENTS or staff.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203 respectively.
3) 4) 5) 6) 7)
IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12
do not apply.
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, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply as modified in
Clause 202 and Clause 203 respectively.
IEC 60601-1-8 [2], IEC 60601-1-9 [3], IEC 60601-1-10 [4] do not apply.
NOTE OPERATORS of INTERVENTIONAL X-RAY EQUIPMENT are used to audible signals as specified in this document
rather than the concepts of IEC 60601-1-8.
___________
3) IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential
performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
4) IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design
5) IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
6)
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment
7) IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
intended for use in the emergency medical services environment
– 10 – IEC 60601-2-43:2022 RLV © IEC 2022
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 [5] apply only if the
MANUFACTURER declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in a
HOME HEALTHCARE ENVIRONMENT, and otherwise do not apply.
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 [6] apply only if the
MANUFACTURER declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in an
EMERGENCY MEDICAL SERVICES ENVIRONMENT, and otherwise do not apply.
All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard 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
requirements.
PERFORMANCE
A requirement of a particular standard takes priority over the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the
general standard 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 addresses the content of Clause
1 of the general standard 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.101"
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 addresses
the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 addresses the content
of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the
general IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020
or applicable collateral standard are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard 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 particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the
general standard 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 the general standard 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 particular standard.
Subclauses, figures or tables which are additional to those of the general standard
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 the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through 3.139154, additional definitions 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.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly relevant, is not to be applied, a statement to
that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
NOTE Informative references are listed in the Bibliography.
Amendment:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
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
Delete the reference to IEC 60601-1-8 and its amendments.
Addition:
IEC 60580:20002019, 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 60601-2-54:20092022, Medical electrical equipment – Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment for radiography and
radioscopy
IEC 60601-2-54:2009/AMD1:2015
IEC 60601-2-54:2009/AMD2:2018
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
– 12 – IEC 60601-2-43:2022 RLV © IEC 2022
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
ISO 14971, Medical devices – Application of risk management to medical devices
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 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021, IEC 60601-2-54:2009,
IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-54:2009/AMD2:20182022,
IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply.
NOTE 1 The location of defined terms is listed in the Index of defined terms.
NOTE 2 The reference point labelled as ‘interventional reference point’ in Edition 1 is replaced by PATIENT ENTRANCE
REFERENCE POINT in this edition.
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
Addition:
201.3.205201
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.204202
EMERGENCY RADIOSCOPY
RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
201.3.201203
* IMAGE DISPLAY DELAY
during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-RAY
LOADING used to create an image and the DISPLAY of this event on the image
201.3.202204
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
201.3.203205
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
RGI PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into
the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
treatment or diagnosis of the medical condition of the PATIENT
201.3.206
SKIN DOSE
estimated ABSORBED DOSE to the skin at a specific point
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
201.4 General requirements
Clause 4 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Subclause 201.4.3 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:20152022 applies,
except as follows:
Addition:
NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of
IEC 60601-2-54:2022 specifies a limitation in applying subclause 203.6.4.3.104.3 (Accuracy of X-RAY TUBE VOLTAGE)
and 203.6.4.3.104.4 (Accuracy of X-RAY TUBE CURRENT) of IEC 60601-2-54:2022. This limitation is also valid for the
ESSENTIAL PERFORMANCE list.
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
the MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
201.4.10.2 SUPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
Subclause 201.4.10.2 of IEC 60601-2-54:20092022 applies.
Additional subclauses:
201.4.101 * Recovery management
The time to recover all of the functions necessary for performing EMERGENCY RADIOSCOPY, after
a failure recoverable automatically or by the OPERATOR shall be as short as reasonably
practicable. The RISK MANAGEMENT shall take into account the availability of emergency power
supply in the determination of the recovery time.
When the recovery is complete, a reinitiation of IRRADIATION shall be required to produce further
IRRADIATION.
The time to recover all functions, after a failure recoverable automatically or by the OPERATOR,
shall be as short as reasonably practicable.
In case of a manually recoverable failure, the time to recover all functions shall not exceed
10 min from the time the OPERATOR has initiated the recovery to the time the INTERVENTIONAL
X-RAY EQUIPMENT has all functions available.
– 14 – IEC 60601-2-43:2022 RLV © IEC 2022
In case of an automatically detected and automatically recoverable failure, the time to recover
all functions shall not exceed 10 min from the time of the failure of the INTERVENTIONAL X-RAY
EQUIPMENT to the time the INTERVENTIONAL X-RAY EQUIPMENT has all functions available.
INTERVENTIONAL X-RAY EQUIPMENT may can have both recovery modes.
NOTE Less than 1 min is a desirable value for the time to recover all functions for performing EMERGENCY
RADIOSCOPY. Less than 3 min is a desirable value to recover all functions.
The instructions for use shall indicate:
– the time necessary to get all functions for EMERGENCY RADIOSCOPY operable;
– the time to restore all functions of the INTERVENTIONAL X-RAY EQUIPMENT;
– for failures recoverable by the OPERATOR, the required PROCEDURE which the OPERATOR must
can follow to perform this recovery.
When the system is in the EMERGENCY RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The functions necessary for performing EMERGENCY RADIOSCOPY shall include, at minimum:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION that was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible to
the one which was used at the time of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the GANTRY;
– normal operation of tableside controls for all functions described above;
– normal operation of the IRRADIATION disabling switch (see 203.6.103);
– normal operation of the motion disabling switch (see 201.9.2.3.1 of IEC 60601-2-54:2009
and IEC 60601-2-54:2009/AMD1:20152022);
– normal operation of anti-collision functions (see 201.9.2.4).
Compliance is checked by inspection of the instructions for use and the RISK MANAGEMENT FILE
and by functional tests.
201.4.102 * RADIATION dose documentation
The INTERVENTIONAL X-RAY EQUIPMENT shall create RADIATION DOSE STRUCTURED REPORTS
(RDSR) and shall have the ability to perform RDSR END OF PROCEDURE TRANSMISSION.
The RDSR shall contain the data elements that are required (‘shall’) in 5.1.2 and 5.1.3 of
IEC 61910-1:2014.
The RDSR should contain the data elements that are recommended (‘should’) in 5.1.2 and 5.1.3
of IEC 61910-1:2014.
NOTE The conditional statements associated with the data elements in IEC 61910-1:2014 are considered to be part
of these data elements.
If the INTERVENTIONAL X-RAY EQUIPMENT does not have means to determine GANTRY angulations,
the RDSR need not contain the data elements related to positioner angles.
The data elements shall be populated with the specified data.
Compliance is checked by appropriate inspection and functional test.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:
For INTERVENTIONAL X-RAY EQUIPMENT that is to be used only in controlled environments, as
specified in the ACCOMPANYING DOCUMENTS, no humidity preconditioning treatment is required.
The ACCOMPANYING DOCUMENTS shall include the time period that to maintain the room
environmental operating conditions need to be maintained prior to powering the system on.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard 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 the general standard 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
Subclause 201.7.2.7 of IEC 60601-2-54:20092022 applies.
201.7.2.15 Cooling conditions
Subclause 201.7.2.15 of IEC 60601-2-54:20092022 applies.
Additional subclauses:
201.7.2.101 BEAM LIMITING DEVICE
Subclause 201.7.2.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:20152022
applies.
201.7.2.102 * PATIENT SUPPORT load
The PATIENT SUPPORT shall be marked with the maximum permissible mass in kilograms for
NORMAL USE, excluding use for cardiopulmonary resuscitation (CPR).
This maximum permissible mass shall be the SAFE WORKING LOAD minus the CPR loading (see
201.9.8.3.1 for CPR loading value).
– 16 – IEC 60601-2-43:2022 RLV © IEC 2022
201.7.2.103 Cardiopulmonary resuscitation (CPR)
The PATIENT SUPPORT shall be marked with abbreviated instructions on configuring the
INTERVENTIONAL X-RAY EQUIPMENT for CPR.
201.7.2.104 Marking of compliance
If, for INTERVENTIONAL X-RAY EQUIPMENT, compliance with this document is to be marked on the
outside of the INTERVENTIONAL X-RAY EQUIPMENT, the marking shall be made in combination with
the MODEL OR TYPE REFERENCE as follows:
INTERVENTIONAL X-RAY EQUIPMENT [model or type reference] IEC 60601-2-43:2010, IEC 60601-
2-43:2010/AMD1:2017 and IEC 60601-2-43:2010/AMD2:20192022.
201.7.2.105 * Protection against ingress of liquids
Specific parts ENCLOSURES of the INTERVENTIONAL X-RAY EQUIPMENT, which are located in the
PATIENT vicinity (or around the PATIENT), shall be marked with the degree of protection as defined
in IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013. When an
ACCESSORY is required for protection against ingress of liquids, this shall be stated in the
instructions for use.
NOTE 1 This is an addition compared to the first edition of IEC 60601-2-43:2000.
NOTE 2 1 See also 201.11.6.5.103.
NOTE 3 2 The marking of parts that are IPX0 need not be marked is optional.
201.7.8.1 Colours of indicator lights
The indication of X-RAY related states shall be excluded from subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
Subclause 201.7.8.1 of IEC 60601-2-54:2022 applies.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Subclause 201.7.9.1 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:20182022
applies.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Subclause 201.7.9.2.1 of IEC 60601-2-54:20092022 applies.
201.7.9.2.12 * Cleaning, disinfection and sterilization
Addition:
NOTE In order to satisfy 11.6.6 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, the information given has to exclude preferably excludes commonly used but possibly
corrosive substances, such as sodium hypochlorite, if the use of such substances would present a RISK of damage
to the parts of the INTERVENTIONAL X-RAY EQUIPMENT concerned.
201.7.9.2.17 ME EQUIPMENT emitting radiation
Subclause 201.7.9.2.17 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:20152022
applies.
NOTE The corresponding requirements in 203.5 cited in subclause 201.7.9.2.17 of IEC 60601-2-54:2022 are
located in 203.5 of this document and not in subclause 203.5 of IEC 60601-2-54:2022.
Additional subclauses:
201.7.9.2.101 PROTECTIVE DEVICES and ACCESSORIES
A list shall be provided of PROTECTIVE DEVICES and ACCESSORIES recommended when the
...
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
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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
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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 60601-2-43 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.
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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;
RAY TUBE
d) the former subclause 201.11.101 “Protection against excessive temperature of X-
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.
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 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.
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.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.
– 6 – IEC 60601-2-43:2022 © IEC 2022
INTRODUCTION
The purpose of this new edition is to introduce changes to reference the Amendment 2 (2020)
to IEC 60601-1:2005 and some minor technical clarifications.
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES can subject
PATIENTS and OPERATORS to higher levels of RADIATION than those which normally prevail during
diagnostic X-ray imaging procedures. One consequence for the PATIENT can be the occurrence
of deterministic injury when RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES involve the
delivery of substantial amounts of RADIATION to localized areas. Another consequence can be
an increased RISK of stochastic effects, such as cancer. These health concerns apply also to
the OPERATOR. In addition, for this particular type of equipment, there is a need for availability
of critical functions with minimal periods of loss.
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES of the type envisaged are well
established in clinical fields such as:
– invasive cardiology;
– interventional RADIOLOGY;
– interventional neuroradiology.
These RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES also include many newly
developing and emerging applications in a wide range of medical and surgical specialties.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
which sometimes do not align with the provisions of this document.
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures
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 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.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL
X-RAY EQUIPMENT complying with this document is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT
in an operating room environment were not considered in this document; therefore, no specific requirements have
been developed for these devices or uses. In any case, such devices or uses remain under the general clause
requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this document and
not by IEC 60601-2-44 [1] . No additional requirements for operation in cone-beam CT mode were identified for this
document (see also Note 5 in 203.6.4.5).
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.
___________
Numbers in square brackets refer to the Bibliography.
– 8 – IEC 60601-2-43:2022 © IEC 2022
201.1.2 Object
Replacement:
The object of this document is:
BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the
– to establish particular
design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES, as defined in 201.3.205.
– to specify information which shall be provided with such INTERVENTIONAL X-RAY EQUIPMENT
RESPONSIBLE ORGANIZATION and OPERATOR in managing the
for the assistance of the
RADIATION RISK and equipment failure RISK arising from these RADIOSCOPICALLY GUIDED
INTERVENTIONAL PROCEDURES which could affect PATIENTS or staff.
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, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021 apply as modified in
Clause 202 and Clause 203 respectively.
IEC 60601-1-8 [2], IEC 60601-1-9 [3], IEC 60601-1-10 [4] do not apply.
NOTE OPERATORS of INTERVENTIONAL X-RAY EQUIPMENT are used to audible signals as specified in this document
rather than the concepts of IEC 60601-1-8.
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 [5] apply only if the
MANUFACTURER declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in a
HOME HEALTHCARE ENVIRONMENT, and otherwise do not apply.
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 [6] apply only if the
MANUFACTURER declares that the ME EQUIPMENT or ME SYSTEM is intended to be operated in an
EMERGENCY MEDICAL SERVICES ENVIRONMENT, and otherwise do not apply.
All other published collateral standards in the IEC 60601-1 series apply as published.
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 particular standard 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 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.101" where x is the final digit(s) of the collateral standard
document number (e.g. 202.4 addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 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 or applicable collateral standard 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 particular standard.
"Addition" means that the text of this particular standard 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 particular standard.
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 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 particular standard, the clause or
subclause of the IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of the IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard, although possibly relevant, is not to be applied, a statement to that effect is given in
this particular standard.
201.2 Normative references
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
NOTE Informative references are listed in the Bibliography.
Amendment:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
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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
Delete the reference to IEC 60601-1-8 and its amendments.
Addition:
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 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 TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
ISO 14971, Medical devices – Application of risk management to medical devices
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 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008,
IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021, IEC 60601-2-54:2022,
IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply.
NOTE The location of defined terms is listed in the Index of defined terms.
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
Addition:
201.3.201
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.202
EMERGENCY RADIOSCOPY
RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
201.3.203
* IMAGE DISPLAY DELAY
during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-RAY
LOADING used to create an image and the DISPLAY of this event on the image
201.3.204
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
201.3.205
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
RGI PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into
PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
the
treatment or diagnosis of the medical condition of the PATIENT
201.3.206
SKIN DOSE
estimated ABSORBED DOSE to the skin at a specific point
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
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:
201.4.3 * ESSENTIAL PERFORMANCE
Subclause 201.4.3 of IEC 60601-2-54:2022 applies, except as follows:
Addition:
NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of
IEC 60601-2-54:2022 specifies a limitation in applying subclause 203.6.4.3.104.3 (Accuracy of X-RAY TUBE VOLTAGE)
and 203.6.4.3.104.4 (Accuracy of X-RAY TUBE CURRENT) of IEC 60601-2-54:2022. This limitation is also valid for the
ESSENTIAL PERFORMANCE list.
Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
the MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
201.4.10.2 SUPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
Subclause 201.4.10.2 of IEC 60601-2-54:2022 applies.
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Additional subclauses:
201.4.101 * Recovery management
The time to recover all of the functions necessary for performing EMERGENCY RADIOSCOPY, after
a failure recoverable automatically or by the OPERATOR shall be as short as reasonably
practicable. The RISK MANAGEMENT shall take into account the availability of emergency power
supply in the determination of the recovery time.
When the recovery is complete, a reinitiation of IRRADIATION shall be required to produce further
IRRADIATION.
The time to recover all functions, after a failure recoverable automatically or by the OPERATOR,
shall be as short as reasonably practicable.
In case of a manually recoverable failure, the time to recover all functions shall not exceed
10 min from the time the OPERATOR has initiated the recovery to the time the INTERVENTIONAL
X-RAY EQUIPMENT has all functions available.
In case of an automatically detected and automatically recoverable failure, the time to recover
all functions shall not exceed 10 min from the time of the failure of the INTERVENTIONAL X-RAY
EQUIPMENT to the time the INTERVENTIONAL X-RAY EQUIPMENT has all functions available.
INTERVENTIONAL X-RAY EQUIPMENT can have both recovery modes.
NOTE Less than 1 min is a desirable value for the time to recover all functions for performing EMERGENCY
RADIOSCOPY. Less than 3 min is a desirable value to recover all functions.
The instructions for use shall indicate:
– the time necessary to get all functions for EMERGENCY RADIOSCOPY operable;
– the time to restore all functions of the INTERVENTIONAL X-RAY EQUIPMENT;
– for failures recoverable by the OPERATOR, the required PROCEDURE which the OPERATOR can
follow to perform this recovery.
When the system is in the EMERGENCY RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The functions necessary for performing EMERGENCY RADIOSCOPY shall include, at minimum:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION that was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible to
the one which was used at the time of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the GANTRY;
– normal operation of tableside controls for all functions described above;
– normal operation of the IRRADIATION disabling switch (see 203.6.103);
– normal operation of the motion disabling switch (see 201.9.2.3.1 of IEC 60601-2-54:2022);
– normal operation of anti-collision functions (see 201.9.2.4).
Compliance is checked by inspection of the instructions for use and the RISK MANAGEMENT FILE
and by functional tests.
201.4.102 * RADIATION dose documentation
The INTERVENTIONAL X-RAY EQUIPMENT shall create RADIATION DOSE STRUCTURED REPORTS
(RDSR) and shall have the ability to perform RDSR END OF PROCEDURE TRANSMISSION.
The RDSR shall contain the data elements that are required (‘shall’) in 5.1.2 and 5.1.3 of
IEC 61910-1:2014.
The RDSR should contain the data elements that are recommended (‘should’) in 5.1.2 and 5.1.3
of IEC 61910-1:2014.
NOTE The conditional statements associated with the data elements in IEC 61910-1:2014 are considered to be part
of these data elements.
If the INTERVENTIONAL X-RAY EQUIPMENT does not have means to determine GANTRY angulations,
the RDSR need not contain the data elements related to positioner angles.
The data elements shall be populated with the specified data.
Compliance is checked by appropriate inspection and functional test.
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, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:
For INTERVENTIONAL X-RAY EQUIPMENT that is used only in controlled environments, as specified
in the ACCOMPANYING DOCUMENTS, no humidity preconditioning treatment is required. The
ACCOMPANYING DOCUMENTS shall include the time period to maintain the room environmental
operating conditions prior to powering the system on.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
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
Subclause 201.7.2.7 of IEC 60601-2-54:2022 applies.
201.7.2.15 Cooling conditions
Subclause 201.7.2.15 of IEC 60601-2-54:2022 applies.
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Additional subclauses:
201.7.2.101 BEAM LIMITING DEVICE
Subclause 201.7.2.101 of IEC 60601-2-54:2022 applies.
201.7.2.102 * PATIENT SUPPORT load
The PATIENT SUPPORT shall be marked with the maximum permissible mass in kilograms for
NORMAL USE, excluding use for cardiopulmonary resuscitation (CPR).
This maximum permissible mass shall be the SAFE WORKING LOAD minus the CPR loading (see
201.9.8.3.1 for CPR loading value).
201.7.2.103 Cardiopulmonary resuscitation (CPR)
The PATIENT SUPPORT shall be marked with abbreviated instructions on configuring the
INTERVENTIONAL X-RAY EQUIPMENT for CPR.
201.7.2.104 Marking of compliance
If compliance with this document is marked on the outside of the INTERVENTIONAL X-RAY
EQUIPMENT, the marking shall be made in combination with the MODEL OR TYPE REFERENCE as
follows:
INTERVENTIONAL X-RAY EQUIPMENT [model or type reference] IEC 60601-2-43:2022.
201.7.2.105 * Protection against ingress of liquids
ENCLOSURES of the INTERVENTIONAL X-RAY EQUIPMENT, which are located in the PATIENT vicinity
(or around the PATIENT), shall be marked with the degree of protection as defined in
IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013. When an
ACCESSORY is required for protection against ingress of liquids, this shall be stated in the
instructions for use.
NOTE 1 See also 201.11.6.5.103.
NOTE 2 The marking of parts that are IPX0 is optional.
201.7.8.1 Colours of indicator lights
Subclause 201.7.8.1 of IEC 60601-2-54:2022 applies.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Subclause 201.7.9.1 of IEC 60601-2-54:2022 applies.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Subclause 201.7.9.2.1 of IEC 60601-2-54:2022 applies.
201.7.9.2.12 * Cleaning, disinfection and sterilization
Addition:
NOTE In order to satisfy 11.6.6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, the information given preferably excludes commonly used but possibly corrosive
substances, such as sodium hypochlorite, if the use of such substances would present a RISK of damage to the parts
of the INTERVENTIONAL X-RAY EQUIPMENT concerned.
201.7.9.2.17 ME EQUIPMENT emitting radiation
Subclause 201.7.9.2.17 of IEC 60601-2-54:2022 applies.
NOTE The corresponding requirements in 203.5 cited in subclause 201.7.9.2.17 of IEC 60601-2-54:2022 are
located in 203.5 of this document and not in subclause 203.5 of IEC 60601-2-54:2022.
Additional subclauses:
201.7.9.2.101 PROTECTIVE DEVICES and ACCESSORIES
A list shall be provided of PROTECTIVE DEVICES and ACCESSORIES recommended when the
INTERVENTIONAL X-RAY EQUIPMENT is employed for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES. There may be different lists for different types of RGI PROCEDURES. The listing can
include PROTECTIVE DEVICES such as PROTECTIVE CLOTHING, recommended for use but not
forming part of the INTERVENTIONAL X-RAY EQUIPMENT.
201.7.9.2.102 * Provisions for cardiopulmonary resuscitation (CPR)
The instruction for use shall include instructions for at least one method of configuring the
INTERVENTIONAL X-RAY EQUIPMENT to permit CPR including the use of any necessary
ACCESSORIES provided with the INTERVENTIONAL X-RAY EQUIPMENT. These instructions shall not
call for the use of ACCESSORIES that are not provided with the INTERVENTIONAL X-RAY EQUIPMENT.
If instructions differ between NORMAL USE and in cases of SINGLE FAULT CONDITIONS, the
instructions shall be given for all appropriate cases.
201.7.9.2.103 * Emergency instructions
Emergency instructions shall be provided in non-electronic form, resistant to manipulation,
water damage and cleaning.
The content of the emergency instructions should be reproduced in a single location in the
complete instructions for use.
Emergency instructions shall contain only instructions related to emergency functions and
situations.
At minimum, emergency instructions shall include instructions for the following cases:
• configuring the INTERVENTIONAL X-RAY EQUIPMENT for CPR (only for INTERVENTIONAL X-RAY
EQUIPMENT including a PATIENT SUPPORT) (see 201.7.9.2.102);
• the re-starting PROCEDURE in case of recoverable failure by the OPERATOR (see 201.4.101);
• the re-starting PROCEDURE for the INTERVENTIONAL X-RAY EQUIPMENT in the event of failure of
SUPPLY MAINS (see 201.7.9.2.104);
• the re-starting PROCEDURE for the INTERVENTIONAL X-RAY EQUIPMENT in the case of the use
of an emergency power supply requiring such actions (see 201.7.9.2.104);
• the location, function and operation of the IRRADIATION disabling switch (see 203.5.2.4.101);
• the location, function and operation of the motion disabling switch (see 201.9.2.3.1 in
IEC 60601-2-54:2022);
– 16 – IEC 60601-2-43:2022 © IEC 2022
• the list of emergency functions, as defined in 201.4.101;
• if the complete instructions for use are only available in electronic form, instructions for
accessing the complete instructions for use.
Compliance is determined by inspection and by the appropriate functional tests.
201.7.9.2.104 Failure of SUPPLY MAINS
The instructions for use shall describe the functional response and re-starting PROCEDURE for
the INTERVENTIONAL X-RAY EQUIPMENT in the event of failure of the SUPPLY MAINS.
Compliance is determined by inspection of the instructions for use.
201.7.9.2.105 Description of the protection against ingress of liquids
The instructions for use shall explain the IPXY marking used on the INTERVENTIONAL X-RAY
EQUIPMENT.
NOTE See also 201.7.2.105.
201.7.9.3 Technical description
Additional subclauses:
201.7.9.3.101 X-RAY SOURCE ASSEMBLY
Subclause 201.7.9.3.101 of IEC 60601-2-54:2022 applies.
201.7.9.3.102 Installation
For PERMANENTLY INSTALLED INTERVENTIONAL X-RAY EQUIPMENT, the technical description shall
contain the following recommendations concerning the installation of the INTERVENTIONAL X-RAY
EQUIPMENT:
– INTERLOCKS must not be present on the doors of the room containing the INTERVENTIONAL X-
RAY EQUIPMENT. No other measures, whether or not employed for RADIATION PROTECTION,
should be able to cause the interruption of IRRADIATION or any other disturbance of a RGI
in progress, unless the OPERATO
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