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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
IEC 60601-2-43:2010-03/AMD2:2019-10(en-fr)
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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• withdrawn,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 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 – Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for radiography and
radioscopy
IEC 60601-2-54:2009/AMD1:2015
IEC 60601-2-54:2009/AMD2:2018
201.3 Terms and definitions
Replace the first existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, by the
following new paragraph:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3/AMD1:2013,
IEC 60601-2-54:2009, IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-
54:2009/AMD2:2018, IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the
following apply.
Add, after the existing definition 201.3.204, added by IEC 60601-2-43:2010/AMD1:2017, the
following new terms and definitions:
201.3.205
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.206
SKIN DOSE
estimated ABSORBED DOSE to the skin at a specific point
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
201.4.102 RADIATION dose documentation
Add, at the end of the paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, but before
the compliance statement, the following new paragraph:
The data elements shall be populated with the specified data.
Replace the existing compliance statement by the following new compliance statement:
Compliance is checked by appropriate inspection and functional test.
IEC 2019
201.5 General requirements for testing of ME EQUIPMENT
Replace the existing text by the following new text:
Clause 5 of the general standard applies, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:
For INTERVENTIONAL X-RAY EQUIPMENT that is to be used only in controlled environments, as
specified in the ACCOMPANYING DOCUMENTS, no humidity preconditioning treatment is required.
The ACCOMPANYING DOCUMENTS shall include the time period that the room environmental
operating conditions need to be maintained prior to powering the system on.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.2.104 Marking of compliance
Replace, in the second existing paragraph, the reference "IEC 60601-2-43:2010" by
"IEC 60601-2-43:2010, IEC 60601-2-43:2010/AMD1:2017, IEC 60601-2-43:2010/AMD2:2019".
201.7.2.105 Protection against ingress of liquids
Replace, in the existing paragraph, the reference "IEC 60529" by "IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
201.7.9.1 General
Replace the existing text by the following new text:
Subclause 201.7.9.1 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.7.9.101 Additional
...