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
SIST EN IEC 60601-2-43:2023
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
SIST EN IEC 60601-2-43:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-43:2023
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SIST EN IEC 60601-2-43:2023
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
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SIST EN IEC 60601-2-43:2023
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)
2
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SIST EN IEC 60601-2-43:2023
EN IEC 60601-2-43:2023 (E)
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.
1
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.
1
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.
3
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SIST EN IEC 60601-2-43:2023
EN IEC 60601-2-43:2023 (E)
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
4
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SIST EN IEC 60601-2-43:2023
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60601-2-43:2023
– 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
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SIST EN IEC 60601-2-43:2023
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,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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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.
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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SIST EN IEC 60601-2-43:2023
– 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.
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SIST EN IEC 60601-2-43:2023
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.
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SIST EN IEC 60601-2-43:2023
– 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.
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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
1
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.
___________
1
Numbers in square brackets refer to the Bibliography.
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– 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.
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SIST EN IEC 60601-2-43:2023
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 Claus
...
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-43:2022
01-februar-2022
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke
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
Ta slovenski standard je istoveten z: prEN IEC 60601-2-43:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN IEC 60601-2-43:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 60601-2-43:2022
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oSIST prEN IEC 60601-2-43:2022
62B/1264/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-43 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-12-03 2022-02-25
SUPERSEDES DOCUMENTS:
62B/1263/RR
IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
TITLE:
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and
essential performance of X-ray equipment for interventional procedures
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing
National Committee positions. You may not copy or "mirror" the file or printed version of the document, or any
part of it, for any other purpose without permission in writing from IEC.
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oSIST prEN IEC 60601-2-43:2022
62B/1264/CDV – 2 – IEC CDV 60601-2-43 © IEC 2021
1 CONTENTS
2 FOREWORD . 3
3 INTRODUCTION . 6
4 201.1 Scope, object and related standards . 7
5 201.2 Normative references . 9
6 201.3 Terms and definitions . 10
7 201.4 General requirements . 11
8 201.5 General requirements for testing of ME EQUIPMENT . 12
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
10 201.7 ME EQUIPMENT identification, marking and documents . 13
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 19
14 201.11 Protection against excessive temperatures and other HAZARDS . 19
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21
16 201.13 HAZARDOUS SITUATIONS and fault conditions . 24
17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS). 24
18 201.15 Construction of ME EQUIPMENT . 24
19 201.16 ME SYSTEMS . 25
20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
21 202 Electromagnetic disturbances – Requirements and tests . 25
22 203 RADIATION PROTECTION in diagnostic X-RAY EQUIPMENT . 25
23 Annexes. 37
24 Annex AA (informative) Particular guidance and rationale . 38
25 Annex BB (normative) Distribution maps of STRAY RADIATION . 50
26 Bibliography . 53
27 Index of defined terms used in this particular standard . 56
28
29 Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration . 51
30 Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration . 52
31
32 Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
33 by MANUFACTURER in the RISK MANAGEMENT analysis . 11
34 Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS . 17
35 Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 26
36 Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL
37 PROCEDURES for which deterministic effects of IRRADIATION are possible . 38
38 Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
39 which deterministic effects are unlikely . 39
40 Table AA.3 – Examples of isodose boundaries and colour codes for SKIN DOSE MAP and
41 AIR KERMA map . 47
42
43
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44 INTERNATIONAL ELECTROTECHNICAL COMMISSION
45
46 ____________
47
48 MEDICAL ELECTRICAL EQUIPMENT –
49
50 Part 2-43: Particular requirements for the basic safety and essential
51 performance of X-ray equipment for interventional procedures
52
53
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
57 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
58 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
59 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
60 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
61 in the subject dealt with may participate in this preparatory work. International, governmental and non-
62 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
63 with the International Organization for Standardization (ISO) in accordance with conditions determined by
64 agreement between the two organizations.
65 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
66 consensus of opinion on the relevant subjects since each technical committee has representation from all
67 interested IEC National Committees.
68 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
69 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
70 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
71 misinterpretation by any end user.
72 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
73 transparently to the maximum extent possible in their national and regional publications. Any divergence
74 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
75 the latter.
76 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
77 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for a ny
78 services carried out by independent certification bodies.
79 6) All users should ensure that they have the latest edition of this publication.
80 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
81 members of its technical committees and IEC National Committees for any personal injury, property damage or
82 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
83 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
84 Publications.
85 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
86 indispensable for the correct application of this publication.
87 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
88 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
89 International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B:
90 Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
91 practice.
92 This third edition constitutes a technical revision.
93 This particular standard has been revised to introduce changes to reference the second
94 amendment:2020 to IEC 60601-1:2005. The present edition remains a system standard for X-
95 RAY EQUIPMENT designed for the use during interventional procedures using X-ray imaging,
96 whether of prolonged or normal duration.
97 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
98 In this standard, the following print types are used:
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99 – Requirements and definitions: roman type.
100 – Test specifications: italic type.
101 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
102 Normative text of tables is also in a smaller type.
103 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
104 NOTED: SMALL CAPITALS.
105 In referring to the structure of this standard, the term
106 – “clause” means one of the seventeen numbered divisions within the table of contents,
107 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
108 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
109 subclauses of Clause 7).
110 References to clauses within this standard are preceded by the term “Clause” followed by the
111 clause number. References to subclauses within this particular standard are by number only.
112 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
113 combination of the conditions is true.
114 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
115 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
116 – “shall” means that compliance with a requirement or a test is mandatory for compliance
117 with this standard;
118 – “should” means that compliance with a requirement or a test is recommended but is not
119 mandatory for compliance with this standard;
120 – “may” is used to describe a permissible way to achieve compliance with a requirement or
121 test.
122 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
123 indicates that there is guidance or rationale related to that item in Annex AA.
124 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
125 equipment, can be found on the IEC website.
126
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127 The committee has decided that the contents of the base publication and its amendments will
128 remain unchanged until the stability date indicated on the IEC web site under
129 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
130 publication will be
131 • reconfirmed,
132 • withdrawn,
133 • replaced by a revised edition, or
134 • amended.
135
IMPORTANT – The 'colour inside' logo on the cover page of this publication 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.
136
137
138
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139 INTRODUCTION
140 The purpose of this new edition is to introduce changes to reference the second
141 amendment:2020 to IEC 60601-1:2005 and some minor technical clarifications.
142 X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may subject
143 PATIENTS and OPERATORS to higher levels of RADIATION than those which normally prevail
144 during diagnostic X-ray imaging procedures. One consequence for the PATIENT may be the
145 occurrence of deterministic injury when RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
146 involve the delivery of substantial amounts of RADIATION to localized areas. Another
147 consequence can be an increased RISK of stochastic effects, such as cancer. These health
148 concerns apply also to the OPERATOR. In addition, for this particular type of equipment, there
149 is a need for availability of critical functions with minimal periods of loss.
150 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES of the type envisaged are well
151 established in clinical fields such as:
152 – invasive cardiology;
153 – interventional RADIOLOGY;
154 – interventional neuroradiology.
155 These RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES also include many newly
156 developing and emerging applications in a wide range of medical and surgical specialities.
157 NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
158 which may not align with the provisions of this standard.
159
160
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161 MEDICAL ELECTRICAL EQUIPMENT –
162
163 Part 2-43: Particular requirements for the basic safety and essential
164 performance of X-ray equipment for interventional procedures
165
166
167
168 201.1 Scope, object and related standards
1)
169 Clause 1 of the general standard applies, except as follows:
170 201.1.1 * Scope
171 Replacement:
172 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both
173 FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for
174 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as
175 INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
176 – equipment for RADIOTHERAPY;
177 – equipment for COMPUTED TOMOGRAPHY;
178 – ACCESSORIES intended to be introduced into the PATIENT;
179 – mammographic X-RAY EQUIPMENT;
180 – dental X-RAY EQUIPMENT.
181 NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL
182 X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.
183 NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY
184 EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific
185 requirements have been developed for these devices or uses. In any case, such devi ces or uses remain under the
186 general clause requirements.
187 NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and
2
188 not by IEC 60601-2-44 [2] . No additional requirements for operation in cone-beam CT mode were identified for
189 this standard (see also Note 4 in 203.6.4.5).
190 INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for
191 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT
192 SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this
193 standard.
194 If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY
195 EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will
196 say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY
197 EQUIPMENT and to ME SYSTEMS, as relevant.
198 NOTE 4 See also 4.2 of the general standard.
199 The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54
200 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do
201 not apply.
—————————
1)
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
2)
Figures in square brackets refer to the Bibliography.
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202 201.1.2 Object
203 Replacement:
204 The object of this particular standard is:
205 – to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the
206 design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL
207 PROCEDURES, as defined in 201.3.205.
208 – to specify information which is to be provided with such INTERVENTIONAL X-RAY EQUIPMENT
209 for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the
210 RADIATION RISK and equipment failure RISK arising from these RADIOSCOPICALLY GUIDED
211 INTERVENTIONAL PROCEDURES which could affect PATIENTS or staff.
212 201.1.3 Collateral standards
213 Addition:
214 This particular standard refers to those applicable collateral standards that are listed in
215 Clause 2 of the general standard and Clause 201.2 of this particular standard.
216 IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203
3 ) 4 ) 5 ) 6 )
217 respectively. IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 and
7)
218 IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1
219 series apply as published.
220 201.1.4 Particular standards
221 Replacement:
222 In the IEC 60601 series, particular standards may modify, replace or delete requirements
223 contained in the general standard and collateral standards as appropriate for the particular
224 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
225 PERFORMANCE requirements.
226 A requirement of a particular standard takes priority over the general standard.
227 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
228 Collateral standards are referred to by their document number.
229 The numbering of clauses and subclauses of this particular standard corresponds to that of
230 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
231 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
232 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
233 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
—————————
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
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234 standard, 203.4 in this particular standard addresses the content of Clause 4 of the
235 IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
236 specified by the use of the following words:
237 "Replacement" means that the clause or subclause of the general standard or applicable
238 collateral standard is replaced completely by the text of this particular standard.
239 "Addition" means that the text of this particular standard is additional to the requirements of
240 the general standard or applicable collateral standard.
241 "Amendment" means that the clause or subclause of the general standard or applicable
242 collateral standard is amended as indicated by the text of this particular standard.
243 Subclauses, figures or tables which are additional to those of the general standa rd are
244 numbered starting from 201.101. However, due to the fact that definitions in the general
245 standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered
246 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
247 aa), bb), etc.
248 Subclauses, figures or tables which are additional to those of a collateral standard are
249 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
250 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
251 The term "this standard" is used to make reference to the general standard, any applicable
252 collateral standards and this particular standard taken together.
253 Where there is no corresponding clause or subclause in this particular standard, the cla use or
254 subclause of the general standard or applicable collateral standard, although possibly not
255 relevant, applies without modification; where it is intended that any part of the general
256 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
257 statement to that effect is given in this particular standard.
258 201.2 Normative references
259 Clause 2 of the general standard applies, except as follows:
260 NOTE Informative references are listed in the Bibliography beginning on page 54.
261 Amendment:
262 IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
263 IEC 60529:1989/AMD1:1999
264 IEC 60529:1989/AMD2:2013
265 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
266 safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
267 ray equipment
268 IEC 60601-1-3:2008/AMD1:2013
269 IEC 60601-1-3:2008/AMD2:2021
270 IEC 60601-1-8 does not apply.
271 Addition:
272 IEC 60580:2019, Medical electrical equipment – Dose area product meters
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273 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
274 safety and essential performance
275 IEC 60601-1:2005/AMD1:2012
276 IEC 60601-1:2005/AMD2:2020
277 IEC 60601-2-54:20xx, Medical electrical equipment – Part 2-54: Particular requirements for
278 the basic safety and essential performance of X-ray equipment for radiography and
279 radioscopy
280 IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
281 IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
282 Radiation dose structured reports for radiography and radioscopy
283 IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
284 devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
285 radiographic imaging
286 201.3 Terms and definitions
287 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
288 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008,
289 IEC 60601-1-3/AMD1:2013 and IEC 60601-1-3/AMD2:2021, IEC 60601-2-54:20xx,
290 IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply.
291 NOTE 1 An index of defined terms is found beginning on page 56.
292 Addition:
293 201.3.201
294 DOSE MAP
295 representation of the spatial distribution of a RADIATION dose quantity
296 201.3.202
297 EMERGENCY RADIOSCOPY
298 RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
299 recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
300 201.3.203
301 * IMAGE DISPLAY DELAY
302 during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-ray
303 LOADING used to create an image and the DISPLAY of this event on the image
304 201.3.204
305 INTERVENTIONAL X-RAY EQUIPMENT
306 X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
307 201.3.205
308 RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
309 RGI PROCEDURE
310 invasive procedure (involving the introduction of a device, such as a needle or a catheter into
311 the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
312 treatment or diagnosis of the medical condition of the PATIENT
313 201.3.206
314 SKIN DOSE
315 estimated ABSORBED DOSE to the skin at a specific point
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316 201.3.207
317 SKIN DOSE MAP
318 DOSE MAP of the SKIN DOSE
319 201.4 General requirements
320 Clause 4 of the general standard applies, except as follows:
321 201.4.3 * ESSENTIAL PERFORMANCE
322 Subclause 201.4.3 of IEC 60601-2-54:20xx, except as follows:
323 Addition:
324 NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of IEC 60601-2-54
325 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
326 (Accuracy of X-RAY TUBE CURRENT). This limitation is also valid for the ESSENTIAL PERFORMANCE list.
327 Additional potential ESSENTIAL PERFORMANCE requirements are found in the subclauses listed
328 in Table 201.101.
329 Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
330 MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
331
332 201.4.10.2 SUPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
333 Subclause 201.4.10.2 of IEC 60601-2-54:20xx applies.
334 Additional subclauses:
335 201.4.101 * Recovery management
336 The time to recover all of the functions necessary for performing EMERGENCY RADIOSCOPY,
337 after a failure recoverable automatically or by the OPERATOR shall be as short as reasonably
338 practicable. The RISK MANAGEMENT shall take into account the availability of emergency power
339 supply i
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