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

2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation
2019-11-07 mah: consultant assessment missing: blocked.
2019-11-12 - JO: BT document to remove link to the MDD under review

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

Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC 60601-2-43:2010/A2:2019)

General Information

• Status: Published
• Publication Date: 02-Apr-2020
• 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: 03-Apr-2020
• Completion Date: 03-Apr-2020
• 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
• Ref Project: SIST 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 (IEC 60601-2-43:2010/A2:2019)

Relations

• Replaced By: 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
• Effective Date: 26-Oct-2021
• Amends: 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

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2020
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC
60601-2-43:2010/A2:2019)
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-
43:2010/A2:2019)
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: EN 60601-2-43:2010/A2:2020
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 60601-2-43:2010/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.50; 37.040.25
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 60601-2-43:2010/A2:2019)
Appareils électromédicaux - Partie 2-43: Exigences To be completed
particulières pour la sécurité de base et les performances (IEC 60601-2-43:2010/A2:2019)
essentielles des appareils à rayonnement X lors
d'interventions
(IEC 60601-2-43:2010/A2:2019)
This amendment A2 modifies the European Standard EN 60601-2-43:2010; it was approved by CENELEC on 2019-11-20. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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,
Turkey 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-43:2010/A2:2020 E

European foreword
The text of document 62B/1137/FDIS, future IEC 60601-2-43/A2, 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 60601-2-43:2010/A2:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
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.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-43:2010.
Endorsement notice
The text of the International Standard IEC 60601-2-43:2010/A2:2019 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 standards
indicated:
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 60601-1-12 NOTE Harmonized as EN 60601-1-12

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.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Amendment
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
+EN 1993
60529:1991/corrige
ndum May 1993
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
Addition
IEC 60580 2000 Medical electrical equipment - Dose area EN 60580 2000
product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
Publication Year Title EN/HD Year
IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54: EN 60601-2-54 2009
Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy
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 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -- Part 1: Determination of the
detective quantum efficiency
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
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-43 ®
Edition 2.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 2
AM ENDEMENT 2
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 ISBN 978-2-8322-7349-4

– 2 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/1137/FDIS 62B/1146/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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.
___________
INTRODUCTION to Amendment 2
The purpose of this second amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– scope clarification with regards to MOBILE X-ray equipment and applicability of
IEC 60601-2-54 subclauses;
– reference to IEC 60601-2-54:2009/AMD2:2018 for common subclauses;
– alignment of 201.7.9.1 with IEC 60601-2-54:2009/AMD2:2018 – 201.7.9.1 is no longer
modified;
– inclusion of adapted requirements or recommendations from
IEC 60601-2-54:2009/AMD2:2018 for
• management of radioscopy image storage in 203.6.1.101,
• display of last image hold (LIH RADIOGRAM) in 203.6.7.101, and
• graphical indication of the boundaries of the X-RAY FIELD in 203.8.102.2;
– inclusion of a recommendation for protection of gantry enclosures in 201.11.6.5.103;
– inclusion of a requirement for X-RADIATION pulse repetition frequency during radioscopy
in 203.6.3.103;
IEC 60601-2-43:2010/AMD2:2019 – 3 –
 IEC 2019
– inclusion of a recommendation for a DOSE MAP in 203.6.4.5 with additional definitions
in 201.3;
– inclusion of a requirement for display unit of dose area product in 203.6.4.5;
– addition of a number of technical clarifications.
__________
201.1.1 Scope
Replace the first sentence of the first existing paragraph by the following new sentence:
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.
Replace the third existing note, including the footnote, by the following new note and footnote:
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] . No additional requirements for operation in cone-beam CT mode were identified for this
standard (see also Note 4 in 203.6.4.5).
__________
2) Figures in square brackets refer to the Bibliography.
Add, after the fourth existing note, the following new paragraph:
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54
applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do
not apply.
201.1.3 Collateral standards
Replace, in the second existing paragraph, the second sentence, including its corresponding
footnotes, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new sentence and
footnotes:
6 7 8 9 10
IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 , IEC 60601-1-12 do
not apply.
__________
6 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
7 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
8 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
9 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
10 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

– 4 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
201.2 Normative references
Add, immediately after the instruction "Amendment", the following new reference:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Replace, under "Addition", the existing reference to IEC 60580 and the one to
IEC 60601-2-54, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new
references:
IEC 60580:2000, Medical electrical equipment – Dose area product meters
IEC 60601-2-54:2009, Medical electrical equipment –
...