SIST EN IEC 60601-2-43:2023
(Main)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)
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)
This International Standard 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 standard 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 particular standard; 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 standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 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 standard.
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.
NOTE 4 See also 4.2 of the general standard.
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.
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit und wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2022)
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)
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’acce
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke (IEC 60601-2-43:2022)
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI FIKSNE in MOBILNE RENTGENSKE OPREME, za katero je PROIZVAJALEC izjavil, da je primerna za RADIOSKOPSKO VODENE INTERVENTNE POSTOPKE, v nadaljnjem besedilu INTERVENTNA RENTGENSKA OPREMA. Njegovo področje uporabe ne vključuje:
– opreme za RADIOTERAPIJO;
– opreme za RAČUNALNIŠKO TOMOGRAFIJO;
– PRIPOMOČKOV, namenjenih za vnos v BOLNIKA;
– mamografske RENTGENSKE OPREME;
– zobne RENTGENSKE OPREME.
OPOMBA 1: Primeri RADIOSKOPSKO VODENIH INTERVENTNIH POSTOPKOV, za katere se priporoča uporaba INTERVENTNE RENTGENSKE OPREME, ki je skladna s tem standardom, so podani v dodatku AA.
OPOMBA 2: Posebne zahteve za magnetne navigacijske naprave in za uporabo INTERVENTNE RENTGENSKE OPREME v okolju operacijske sobe niso bile upoštevane v tem standardu, zato za te naprave ali vrste uporabe ni posebnih zahtev. Za take naprave ali vrste uporabe veljajo splošne zahteve.
OPOMBA 3: Za INTERVENTNO RENTGENSKO OPREMO, ki se uporablja v načinu CT s stožčastim žarkom, velja ta standard in ne IEC 60601-2-44 [2]2. Za ta standard niso bile opredeljene nobene dodatne zahteve za delovanje v načinu CT s stožčastim žarkom (glej tudi opombo 4 v 203.6.4.5).
INTERVENTNA RENTGENSKA OPREMA, za katero PROIZVAJALEC izjavlja, da je primerna za RADIOSKOPSKO VODENE INTERVENTNE POSTOPKE, ki ne vključuje OPORE ZA BOLNIKE kot del sistema, je izvzeta iz določb o OPORI ZA BOLNIKE v tem standardu.
Če je točka ali podtočka namenjena samo obravnavi INTERVENTNE RENTGENSKE OPREME ali samo ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini dane točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava oboje, INTERVENTNO RENTGENSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
OPOMBA 4: Glej tudi točko 4.2 splošnega standarda.
Podtočke tega standarda nadomeščajo podtočke standarda IEC 60601-2-54. IEC 60601-2-54 se uporablja le za navedene podtočke; necitirane podtočke standarda IEC 60601-2-54 ne veljajo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2023
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke (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)
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit
und wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für interventionelle
Verfahren (IEC 60601-2-43:2022)
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)
Ta slovenski standard je istoveten z: EN IEC 60601-2-43:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-43
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2023
ICS 11.040.50; 37.040.25 Supersedes EN 60601-2-43:2010;
EN 60601-2-43:2010/AC:2014;
EN 60601-2-43:2010/A1:2018;
EN 60601-2-43:2010/A2:2020
English Version
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)
Appareils électromédicaux - Partie 2-43: Exigences Medizinische elektrische Geräte - Teil 2-43: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und wesentlichen
essentielles des appareils à rayonnement X lors Leistungsmerkmale von Röntgeneinrichtungen für
d'interventions interventionelle Verfahren
(IEC 60601-2-43:2022) (IEC 60601-2-43:2022)
This European Standard was approved by CENELEC on 2023-01-09. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-43:2023 E
European foreword
The text of document 62B/1297/FDIS, future edition 3 of IEC 60601-2-43, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-
43:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-10-09
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-01-09
document have to be withdrawn
This document supersedes EN 60601-2-43:2010 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-43:2022 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-2-44 NOTE Harmonized as EN 60601-2-44
IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:2015 (not modified)
IEC 60601-2-28:2017 NOTE Harmonized as EN IEC 60601-2-28:2019 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Clause 2 of EN 60601-1:2006 , EN 60601-1:2006/A1:2013, and EN 60601-1:2005/A2:2021 applies,
except as follows:
Publication Year Title EN/HD Year
Replace the references to IEC 60529:1989 and IEC 60601-1-3 with the following new references:
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- - + corrigendum May 1993
+ A1 1999 + A1 2000
+ A2 2013 + A2 2013
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+ corrigendum Mar. 2010
+ A1 2013 + A1 2013
+ AC 2014
+ A11 2016
+ A2 2021 + A2 2021
Delete the reference to IEC 60601-1-8 and its amendments.
As impacted by EN 60601-1:2006/corrigendum Mar. 2010, EN 60601-1:2006/A12:2014, EN 60601-
1:2006/A1:2013/AC:2014 and EN 60601-1:2006/AC:2022-12.
Add the following references:
IEC 60580 2019 Medical electrical equipment - Dose area EN IEC 60580 2020
product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
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 EN 61910-1 2014
dose documentation - Part 1: Radiation
dose structured reports for radiography
and radioscopy
IEC 62220-1-1 2015 Medical electrical equipment - EN 62220-1-1 2015
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
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
IEC 60601-2-43:2022 © IEC 2022 – 3 –
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
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-43 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.
– 4 – IEC 60601-2-43:2022 © IEC 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;
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.
IEC 60601-2-43:2022 © IEC 2022 – 5 –
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.
IEC 60601-2-43:2022 © IEC 2022 – 7 –
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.
IEC 60601-2-43:2022 © IEC 2022 – 9 –
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
– 10 – IEC 60601-2-43:2022 © IEC 2022
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
IEC 60601-2-43:2022 © IEC 2022 – 11 –
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.
– 12 – IEC 60601-2-43:2022 © IEC 2022
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.
IEC 60601-2-43:2022 © IEC 2022 – 13 –
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.
– 14 – IEC 60601-2-43:2022 © IEC 2022
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.
IEC 60601-2-43:2022 © IEC 2022 – 15 –
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 docume
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