EN IEC 60601-2-43:2023

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

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

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

IEC 60601-2-43:2022 est disponible sous forme de IEC 60601-2-43:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-43:2022 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS A RAYONNEMENT X FIXES et MOBILES déclarés par leur FABRICANT comme étant adaptés aux INTERVENTIONS GUIDEES PAR RADIOSCOPIE, désignés ci-après par le terme APPAREILS A RAYONNEMENT X D'INTERVENTION. Son domaine d’application exclut en particulier: - les équipements de RADIOTHERAPIE; - les équipements de TOMODENSITOMETRIE; - les ACCESSOIRES destinés à être introduits dans le corps du PATIENT; - les APPAREILS de mammographie A RAYONNEMENT X; - les APPAREILS de radiographie dentaire A RAYONNEMENT X. Les APPAREILS A RAYONNEMENT X D’INTERVENTION déclarés par le FABRICANT comme étant adaptés aux INTERVENTIONS GUIDEES PAR RADIOSCOPIE, qui n’incluent pas le SUPPORT PATIENT sont exemptés des dispositions du présent document applicables au SUPPORT PATIENT. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS A RAYONNEMENT X D’INTERVENTION ou uniquement aux SYSTEMES EM, le titre et le contenu de l’article ou du paragraphe concerné l'indiquent. Si tel n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS A RAYONNEMENT X D’INTERVENTION et aux SYSTEMES EM, selon le cas. L'IEC 60601-2-54 s'applique uniquement en ce qui concerne les paragraphes cités; les paragraphes non cités de l'IEC 60601-2-54 ne s'appliquent pas. L'IEC 60601-2-43:2022 annule et remplace la deuxième édition parue en 2010, l'Amendement 1:2017 et l'Amendement 2:2019. Cette édition constitue une révision technique. Cette édition inclut des modifications rédactionnelles et techniques pour refléter les modifications dans l’IEC 60601 1:2005/AMD2:2020 et l’IEC 60601-2-54:2022. Elle contient également des corrections et des améliorations techniques. Les modifications techniques majeures par rapport à l’édition précédente sont les suivantes: a) un nouveau terme spécifique DOSIMETRE est utilisé pour remplacer le terme général DOSIMETRE comme dans l’IEC 60601-2-54:2022; b) plusieurs termes et définitions de l’IEC TR 60788:2004 déplacés dans l’Article 201.3 de l’IEC 60601-2-54:2022 sont aussi référencés à partir de l’IEC 60601-2-54:2022; c) les normes collatérales IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 et IEC 60601-1-12:2014/AMD1:2020 sont applicables lorsque le FABRICANT les déclare telles quelles; d) l’ancien paragraphe 201.11.101 "Protection contre les températures excessives des GAINES EQUIPEES" est supprimé car il est couvert par l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012, l’IEC 60601-1:2005/AMD2:2020 et l’IEC 60601-2-28:2017 et l’ancien paragraphe 201.11.102 est renuméroté en 201.11.101, comme dans l’IEC 60601-2-54:2022; e) pour adopter les modifications du paragraphe 7.8.1 "Couleurs des voyants lumineux" de l’IEC 60601-1:2005/AMD2:2020, une clarification des exigences est fournie en 201.7.8.1 pour éviter les contradictions avec les exigences des voyants lumineux stipulées pour les APPAREILS A RAYONNEMENT X, comme dans l’IEC 60601-2-54:2022; f) une explication du terme PERFORMANCE ESSENTIELLE est donnée à l’Annexe AA pour mettre l’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

• Status: Published
• Publication Date: 19-Jan-2023
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-Jan-2023
• Due Date: 13-Oct-2023
• Completion Date: 20-Jan-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 60601-2-43:2023 - 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)

Relations

• Replaces: EN 60601-2-43:2010 - Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 22-Jan-2023
• Replaces: EN 60601-2-43:2010/AC:2014 - Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 26-Oct-2021
• Replaces: EN 60601-2-43:2010/A2:2020 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 26-Oct-2021
• Replaces: EN 60601-2-43:2010/A1:2018 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 26-Oct-2021

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 Spe
...