IEC 60601-2-43:2010/AMD2:2019

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

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

General Information

• Status: Published
• Publication Date: 15-Oct-2019
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 41 - TC 62/SC 62B/MT 41
• Current Stage: DELPUB - Deleted Publication
• Start Date: 05-Dec-2022
• Completion Date: 26-Oct-2025

Relations

• Amends: IEC 60601-2-43:2010 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 05-Sep-2023
• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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 statements in ACCOMPANYING DOCUMENTS
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS
Add, after the last row, the following new rows:
201.5.7 Humidity preconditioning treatment
201.11.6.5.103 ENCLOSURES
203.5.2.4.102 EXAMINATION PROTOCOLS
203.6.4.5 Dosimetric indications

Add, after Table 201.102, the following new note:
NOTE While Table 201.C.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 lists the following
subclauses "203.6.4.5 Dosimetric indications" and "203.5.2.4.5.101 Dosimetric information for X-RAY EQUIPMENT
specified for RADIOSCOPY and/or SERIAL RADIOGRAPHY", the corresponding requirements for statements in
ACCOMPANYING DOCUMENTS are located in this standard and not in IEC 60601-2-54:2009 and its amendments.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Delete the sentence: "Clause 8 of the general standard applies, except as follows:"

– 6 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
201.9.8 HAZARDS associated with support systems
Replace the existing title of this subclause by the following new title:
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.3.3 Dynamic forces due to loading from persons
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
201.10 Protection against unwanted and excessive radiation HAZARDS
Replace the existing paragraph, excluding the note, by the following new paragraph:
Clause 201.10 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.11 Protection against excessive temperatures and other HAZARDS
201.11.6.5.103 ENCLOSURES
Add, in the first existing paragraph, the following new sentence to the third dash, modified by
IEC 60601-2-43:2010/AMD1:2017:
For the PATIENT SUPPORT test, testing may be considered sufficient by angulating the PATIENT
SUPPORT 15° from the horizontal position.
Add, in the first existing paragraph, the following item to the dash list:
– X-RAY TUBE ASSEMBLY and associated GANTRY elements should have a minimum degree of
protection of IPX2, except for INTERVENTIONAL X-RAY EQUIPMENT with a FIXED over-table X-
RAY SOURCE ASSEMBLY. The ACCOMPANYING DOCUMENTS shall describe the associated
GANTRY elements that are included within the IPX2 classification. Testing may be
considered sufficient by tilting the C-arm in the least favourable position with a maximum
of 15° in any direction from the vertical position.
Replace, in the second paragraph, the reference "IEC 60529" by "IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
Replace "NOTE 1" by "NOTE".
Delete the second note.
Add, after 201.11.6.5.103, the following new text:
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Subclause 201.11.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Replace, in the note, the reference "under 203.6.4.3 of IEC 60601-2-54:2009" by "under
203.6.4.3 of this document".
 IEC 2019
201.16 ME SYSTEMS
Replace the existing text by the following new text:
Clause 16 of the general standard applies, except as follows:
201.16.8 Interruption of the power supply to parts of an ME SYSTEM
Replacement:
Subclause 201.16.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
203.4.1 Statement of compliance
Replace, in the existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, the
reference "IEC 60601-2-43:2010" by "IEC 60601-2-43:2010, IEC 60601-2-
43:2010/AMD1:2017 and IEC 60601-2-43:2010/AMD2:2019".
Add, after the existing 203.4.101, the following new text:
203.5.2.1 References in subclauses
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS
Amendment:
The row about Clinical protocols, Subclause 5.2.4.4, does not apply.
203.5.2.4 Instructions for use
Add, after the existing 203.5.2.4, the following new subclause:
203.5.2.4.4 Clinical protocols
Subclause 5.2.4.4 of IEC 60601-1-3:2008 does not apply.
203.5.2.4.5.102 Test for dosimetric information
Replace, in the last paragraph, "NOTE 2" by "NOTE".
Add, after the existing 203.5.2.4.101, the following new subclause:
203.5.2.4.102 EXAMINATION PROTOCOLS
Subclause 203.5.2.4.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
NOTE The numbering of the cited subclause from IEC 60601-2-54 is different.
Add, after the existing 203.6, the following new text:
203.6.1 General
Additional subclauses:
– 8 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
203.6.1.101 Management of RADIOSCOPY image storage
NTERVENTIONAL X-RAY EQUIPMENT shall provide the capability to store a RADIOSCOPY REPLAY
I
IMAGE SEQUENCE for display. This capability may be limited to storage of images as follows:
RADIOSCOPY;
– at pulse rates up to 10 pulses per second, the last 30 s of
– for pulse rates greater than 10 pulses per second, the last 300 images;
RADIOSCOPY, the last 10 s of RADIOSCOPY.
– for continuous
This requirement does not apply to MOBILE X-RAY EQUIPMENT with a maximum FOCAL SPOT TO
less than 45 cm and that is specified for extremities use only in its
IMAGE RECEPTOR DISTANCE
INTENDED USE.
NOTE The storage is not required to be a permanent storage.
Compliance is checked by functional test.
203.6.1.102 Management of EXAMINATION PROTOCOLS
Subclause 203.6.1.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
203.6.2 Initiation and termination of the IRRADIATION
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.3 RADIATION dose and RADIATION QUALITY
203.6.3.2 Reproducibility of the RADIATION output
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
Add, after the existing 203.6.3.102, the following new subclause:
203.6.3.103 * X-RADIATION pulse repetition frequency during RADIOSCOPY
If the RADIOSCOPY pulse rate is selectable, the minimum pulse rate shall be less than or equal
to 4 pulses per second.
203.6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.4.5 * Dosimetric indications
Replace the existing note by the following new note:
NOTE 1 Differences related to the same subclause in IEC 60601-2-54:2009, IEC 60601-2-54:2009/AMD1:2015
st rd
and IEC 60601-2-54:2009/AMD2:2018 include: the 1 dash of the 3 paragraph is applicable also to SERIAL
th 2 2
RADIOGRAPHY; in the 4 paragraph, the minimal value is 2,5 Gy⋅cm instead of 5 µGy⋅m , i.e. is 50 times larger; the
DOSE AREA PRODUCT is Gy⋅cm ; a requirement to have means for configuring
recommended unit for displaying the
the display unit of the DOSE AREA PRODUCT is present; additional requirements and recommendations are present
after the requirement about DOSE AREA PRODUCT METERS, including additional requirement and recommendation
about DOSE MAP and SKIN DOSE MAP; and also, unlike in IEC 60601-2-54, there is no specific requirement for
INDIRECT RADIOGRAPHY and DIRECT RADIOGRAPHY.
Add, in the third existing paragraph after the note, the following dashed item to the list:

 IEC 2019
– The displayed values of REFERENCE AIR KERMA RATE and cumulative REFERENCE AIR KERMA
may be measured or calculated.
Add, in the fourth paragraph after the note, the following new text after the third sentence:
Means shall be provided to the RESPONSIBLE ORGANIZATION to allow configuring the unit for
display of DOSE AREA PRODUCT at least among all the following:
– Gy⋅cm ;
2 2
– µGy⋅m or cGy⋅cm ;
– mGy⋅cm .
The instructions for use shall indicate that the unit for display of DOSE AREA PRODUCT is
configurable.
Delete, in the fourth paragraph after the note, the last sentence.
Add, after the fourth paragraph after the note, the following new paragraph:
The overall uncertainty of the displayed values of the cumulative DOSE AREA PRODUCT above
2,50 Gy⋅cm shall not exceed 35 %.
Add, before the compliance statement, the following new text:
The INTERVENTIONAL X-RAY EQUIPMENT should have a DOSE MAP.
NOTE 2 If a DOSE MAP is provided, it is intended for display during the procedure and to be available for export at
the end of the procedure.
NOTE 3 A SKIN DOSE MAP is preferred over other DOSE MAPS. An example of a DOSE MAP can be obtained by
cumulating the values of REFERENCE AIR KERMA over ranges of the available parameters that influence the location
of the X-RAY BEAM relative to the PATIENT. When the INTERVENTIONAL X-RAY EQUIPMENT cannot determine the
orientation of the X-RAY BEAM AXIS, creation of a DOSE MAP is not practical. Mapping head, chest, abdomen and
pelvic anatomy is of primary value; mapping extremities is of secondary value due to smaller body part thickness
and their variability in position on the PATIENT SUPPORT.
A DOSE MAP shall not be designated as a SKIN DOSE MAP, unless the RADIATION dose quantity is
SKIN DOSE.
NOTE 4 Dosimetric indications apply also for operation in cone-beam CT mode. This provides a means to
combine the RADIATION dose for all MODES OF OPERATIONS.
203.6.5 AUTOMATIC CONTROL SYSTEM
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.6 SCATTERED RADIATION reduction
Replace, in the first sentence of the subclause, the reference "IEC 60601-2-54:2009" by
"IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.7 Imaging performance
Replace the existing paragraph by the following new text:
Additional subclause:
– 10 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
203.6.7.101 * Display of LAST IMAGE HOLD RADIOGRAM or RADIOSCOPY REPLAY IMAGE
SEQUENCE
INTERVENTIONAL X-RAY EQUIPMENT shall be equipped with means to display either a LIH
RADIOGRAM or a RADIOSCOPY REPLAY IMAGE SEQUENCE following termination of the radioscopic
IRRADIATION and shall comply with the following.
1) When the LIH RADIOGRAM is displayed, it shall be displayed following termination of the
radioscopic IRRADIATION and shall remain visible either until an action by the OPERATOR or
until display of the RADIOSCOPY REPLAY IMAGE SEQUENCE.
2) Means shall be provided to clearly indicate to the OPERATOR whether a displayed image is
– a LIH RADIOGRAM or a RADIOSCOPY REPLAY IMAGE SEQUENCE, or
– from ongoing RADIOSCOPY.
3) Display of the LIH RADIOGRAM or the RADIOSCOPY REPLAY IMAGE SEQUENCE shall be replaced
by the RADIOSCOPY image concurrently with reinitiation of radioscopic IRRADIATION, unless
DISPLAY is provided for the RADIOSCOPY images.
a separate
4) For a LIH RADIOGRAM obtained by retaining pre-termination RADIOSCOPY images, if the
number of images and method of combining images are selectable by the OPERATOR, the
selection shall be indicated prior to initiation of the radioscopic IRRADIATION.
Compliance is checked by inspection and functional tests.
203.7 RADIATION QUALITY
Replace, in the existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, the
reference "IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015" by "IEC 60601-2-
54:2009, IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-54:2009/AMD2:2018".
203.8.102 Methods of beam limitation in X-RAY EQUIPMENT
Replace the existing paragraph by the following new text:
Additional subclauses:
203.8.102.1 General
Subclause 203.8.102.1 of IEC 60601-2-54:2009 applies.
203.8.102.2 Indication on the X-RAY EQUIPMENT
INTERVENTIONAL X-RAY EQUIPMENT shall provide a graphical representation of the boundaries
of the X-RAY FIELD on the image DISPLAY while the BEAM LIMITING DEVICE is adjusted when no
IRRADIATION SWITCH is actuated. This representation shall be
– provided at the working position of the OPERATOR, and
– updated during BEAM LIMITING DEVICE adjustment.
203.8.102.3 Indication in the instructions for use
Subclause 203.8.102.3 of IEC 60601-2-54:2009 applies.
203.8.102.4 Accuracy of marked and written indications
Subclause 203.8.102.4 of IEC 60601-2-54:2009 applies.
203.8.103 Interception of the X-RAY BEAM in RADIOSCOPY
Replace the reference "IEC 60601-2-54:2009" by "IEC 60601-2-54:2009 and IEC 60601-2-
54:2009/AMD2:2018".
 IEC 2019
203.9 FOCAL SPOT TO SKIN DISTANCE
Replace the reference "IEC 60601-2-54:2009" by "IEC 60601-2-54:2009 and IEC 60601-2-
54:2009/AMD2:2018".
203.13.6 Test for STRAY RADIATION
Replace the first paragraph by the following new paragraph:
For testing 203.13.4, subclause 13.6 of IEC 60601-1-3:2008 does not apply and Annex BB
applies.
Replace, in the second paragraph, the reference "IEC 60601-2-54" by "IEC 60601-2-54:2009
and IEC 60601-2-54:2009/AMD2:2018".
AA.2 Rationale for particular clauses and subclauses
Subclause 201.11.6.5.103 – ENCLOSURES
Replace, in the first sentence of the existing paragraph, the reference "IEC 60529" by
"IEC 60529:1989 and IEC 60529:1989/AMD2:2013".
Add, after the existing Subclause 203.5.2.4.5.102, the following new text:
Subclause 203.6.3.103 – X-RADIATION pulse repetition frequency during RADIOSCOPY
Radiation usage is optimised when the amount of radiation used to produce an image or an
image series is the least possible that permits adequate visualization of the structures of
interest. International and national guidelines from radiation protection organizations [23] [24]
and medical professional societies [26] [27] [28] recommend that in interventional
RADIOSCOPY, dose rate is reduced to the extent possible. Clinical circumstances can require a
high or low dose per pulse independent of pulse rate. In these situations, the ability to select
a low pulse rate independently of dose per pulse is essential for optimisation.
Subclause 203.6.101 of this document already requires a minimum of two MODES OF
OPERATION for NORMAL USE in RADIOSCOPY – "normal" and "low" REFERENCE AIR KERMA RATES –
with the "low" MODE OF OPERATION providing a REFERENCE AIR KERMA RATE that does not
exceed 50 % of the value for the normal mode. This permits the OPERATOR to select a low
dose rate when clinically appropriate. When a selectable RADIOSCOPY pulse rate is available,
the new requirement extends the OPERATOR'S ability to optimise radiation usage by specifying
OPERATOR to select the lowest
that at least one low pulse rate is available. This will permit the
clinically acceptable pulse rate independently of dose rate.
Subclause 203.6.4.5 – Dosimetric indications
Delete the existing fourth paragraph saying "In relation to DOSE AREA PRODUCT METERS:
Although IEC 60580 allows for SI prefixes, it is recommended to use only the Gy⋅cm unit."
Add, after the last paragraph, the following new paragraphs and table:
In relation to notations:
REFERENCE AIR KERMA is sometimes written differently in the bibliography (e.g. in [23] and
[24]) and denoted as K .
a,r
DOSE AREA PRODUCT is sometimes written differently in the bibliography (e.g. in [23] and 24])
and denoted as air kerma area product P .
KA
– 12 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
In relation to SKIN DOSE MAP:
Introduction:
The application of any form of RADIATION to a PATIENT is part of the practice of medicine. The
practitioner has the responsibility of balancing the expected benefits of a procedure against
associated risks. To meet this goal, the practitioner needs to have timely access to
appropriate information.
X-RAY EQUIPMENT that meets IEC 60601-2-43 or IEC 60601-2-54, or for example U.S.
performance standards (21 CFR 1020.32 [3]) includes dosimetric displays. Depending on the
applicable standard, this includes real time displays of cumulative REFERENCE AIR KERMA at the
PATIENT ENTRANCE REFERENCE POINT, DOSE AREA PRODUCT, or both. The cumulative REFERENCE
AIR KERMA is required to be visible at the OPERATOR's working position. SKIN DOSE MAPS were
foreseen as a logical extension of these real time displays and were recommended in NCRP
Report 168 [23] and ICRP Publication 120 [24]. However, when IEC 60601-2-43:2010 was
published, the technology was not sufficiently developed to include a normative requirement
for SKIN DOSE MAPS.
The distribution of IRRADIATION on the PATIENT has been intermittently available from various
MANUFACTURERS since the late 1990's in various real-time or post-procedure modes.
IEC 61910-1:2014 defines a radiation dose structured report (RDSR) with sufficient
information ("extended dose documentation") to construct a SKIN DOSE MAP using additional
geometric and anatomical information supplied externally to the imaging equipment.
Depending on the use of IEC 61910-1:2014 and the supporting equipment, this might be
either real-time or post-procedure. Some models of X-RAY INTERVENTIONAL EQUIPMENT already
provide integrated SKIN DOSE MAPS using the equipment's own resources.
The clinical goal of these efforts is to provide the OPERATOR with sufficient real-time
information to avoid unnecessary tissue reactions. Reducing the frequency and severity of
tissue reactions is a requirement for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
above the requirements for general procedures (X-RAY EQUIPMENT within the scope of
IEC 60601-2-54).
Real-time dosimetric displays:
Radiation is one of many factors affecting the practitioner's ability to safely and effectively
complete a procedure. Automatic alarms of any kind can result in poorer overall clinical
results if they unnecessarily distract the OPERATOR's attention. Many non-radiation events that
occur during a procedure also require the OPERATOR's attention. Unless OPERATOR action is
urgent, such notifications can be given to the OPERATOR by a knowledgeable participant in the
procedure (located either in the control room or the procedure room) as soon as it is safe to
do so.
Continuous, real-time display provides immediate access to accumulated dosimetric
information without requiring an action or distracting the OPERATOR's concentration. NCRP
Report 168 [23], ICRP Publication 120 [24] and guidelines from interventional radiology [25]
and interventional cardiology [26] societies recommend OPERATOR notification when specified
dosimetric levels, including peak SKIN DOSE, are exceeded. Radiation injuries do not have a
binary dose-response function. Exceeding any nominal radiation threshold by a few tens of
percent is highly unlikely to substantially affect the frequency or nature of any radiation injury.
Some equipment currently has the capability of non-distractively indicating when the
cumulative REFERENCE AIR KERMA exceeds a threshold using means such as reversing the
colours of a display and its background.
DOSE MAPS:
 IEC 2019
The simplest DOSE MAP is a display of the REFERENCE AIR KERMA as a function of gantry angle.
Such maps typically display a single value for all of the IRRADIATION occurring in a range of
angles (e.g. 30° x 30°). Their construction does not require any information about the PATIENT
or the PATIENT's position relative to the beam. Nevertheless, these air kerma maps may be
sufficient for certain aspects of operational radiation management.
During a procedure, the availability of a current SKIN DOSE MAP displayed on a surface that
reasonably represents the actual PATIENT is clinically important. This map needs to indicate
the size, shape, and location of the current X-RAY FIELD(S). Such a display provides the
OPERATOR with immediate information regarding the risks of continuing irradiation and
provides the information necessary to manage the radiation fields so as to control the
likelihood and severity of a cutaneous tissue reaction [29].
The skin surface of the PATIENT can be represented by a model. In that case, the PATIENT
surface model can be a stylized representation of the skin surface of a human. The PATIENT
surface model can be adaptable to the PATIENT under examination. The PATIENT surface model
can exclude PATIENT extremities. For example, the PATIENT surface model could be based on
the PATIENT's height and weight.
Isodose boundaries and colour codes:
OPERATORS may work in one or more locations with different manufacturers' equipment. A
consistent use of isodose boundaries and colour codes is useful to avoid confusion amongst
OPERATORS when working between systems from different MANUFACTURERS.
Table AA.3 presents examples of colour and grayscale code with isodose boundaries. Isodose
boundaries are derived from Table 2.5 from NCRP-168 [23]. Colour and grayscale codes are
expressed in RGB space (see e.g. reference [30] for RGB space description). Lower isodose
boundaries for air kerma maps could be used to keep meaningful biological risk indications.
These could be 75 % of the SKIN DOSE MAP ones since air kerma does not account for effects
like backscatter.
Table AA.3 – Examples of isodose boundaries and colour codes
for SKIN DOSE MAP and air kerma map
SKIN DOSE MAP isodose Air kerma map isodose RGB RGB
boundaries boundaries colour grayscale
A. Example 1
Base surface to < 0,1 Gy Base surface to < 0,075Gy 220,220,220 220,220,220
0,1 Gy 0,075 Gy 0,0,0 0,0,0
1,0 Gy 0,75 Gy 0,0,255 70,70,70
2,0 Gy 1,5 Gy 0,255,0 105,105,105
5,0 Gy 3,75 Gy 255,255,0 145,145,145
8,0 Gy 6,0 Gy 255,128,0 190,190,190
11,0 Gy 8,25 Gy 255,0,0 235,235,235
≥ 15,0 Gy ≥ 11,25 Gy 255,255,255 255,255,255
B. Example 2
0,1 Gy 0,075 Gy 0,0,255 0,0,0
1,0 Gy 0,75 Gy 0,255,0 70,70,70
2,0 Gy 1,5 Gy 255,255,0 105,105,105
3,0 Gy 2,25 Gy 255,128,0 145,145,145
5,0 Gy 3,75 Gy 255,0,0 190,190,190
10,0 Gy 7,5 Gy 240,160,160 235,235,235

– 14 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
≥ 15,0 Gy ≥ 11,25 Gy 255,255,255 255,255,255
NOTE Except for the first and last table entry, the colours used to represent doses between isodose
boundaries could be displayed as either a continuous transition between the values or as the lower dose value.

The following considerations are relevant as part of the design process for a SKIN DOSE MAP.
– The SKIN DOSE MAP is configurable by the OPERATOR to be displayed at least at the position
of the RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE when LOADING in RADIOSCOPY
or RADIOGRAPHY is not active. A second display of the SKIN DOSE MAP in the control room is
a helpful option for OPERATOR notification. The SKIN DOSE MAP includes at least the relevant
anatomical region of the body.
– The PATIENT orientation is apparent on the SKIN DOSE MAP.
– An indication of the current location of the X-RAY FIELD(S) is displayed on the SKIN DOSE
MAP.
– The SKIN DOSE MAP can be displayed as a grayscale or colour-coded image. A colour-
coded map is preferred. When the SKIN DOSE MAP is intended to be displayed without
colour, a dedicated grayscale scheme is necessary.
– Providing a mean to use colour or grayscale schemes different from those shown in
Table AA.3 or provided by the MANUFACTURER is desirable because it promotes future
standardization of the SKIN DOSE MAP display, and therefore could provide additional
PATIENT safety.
– For clinically important values of SKIN DOSE, displayed values of SKIN DOSE are close to
actual SKIN DOSE. The minimum value stated as part of the criterion for accuracy concerns
only the accuracy of the displayed SKIN DOSE. It is not intended to be used to determine
which values of SKIN DOSE are displayed.
– The current value of the highest SKIN DOSE within the current X-RAY FIELD(S) and the
highest SKIN DOSE at any point on the SKIN DOSE MAP (peak SKIN DOSE) are displayed in
conjunction with the SKIN DOSE MAP. These displayed values are CLEARLY LEGIBLE at 1,5 m
from the display, when configured by the OPERATOR.
– Use of tissue equivalent anthropomorphic phantoms for quantifying accuracy.
The following information is relevant for inclusion in the ACCOMPANYING DOCUMENTS:
– description of the PATIENT surface model;
– description of the phantom(s) for quantifying accuracy;
– test conditions and accuracy.
Add, after Subclause 203.6.4.5, the following new text:
Subclause 203.6.7.101 – Display of LAST IMAGE HOLD RADIOGRAM or RADIOSCOPY REPLAY
IMAGE SEQUENCE
INTERVENTIONAL X-RAY EQUIPMENT differs from non-interventional X-RAY EQUIPMENT with
respect to display of a LIH RADIOGRAM. There are specific RADIOSCOPICALLY GUIDED
INTERVENTIONAL PROCEDURES (e.g. a coronary artery chronic total occlusion procedure) for
which the OPERATOR may need to have a display of a reference acquisition image instead of a
LIH display.
While the requirements for display of a LIH RADIOGRAM differ from 203.6.7.101 of
IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018, the LIH RADIOGRAM definition is
the same as in 201.3.212 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018.

 IEC 2019
Bibliography
Add, after the existing reference [22] of the Bibliography, modified by IEC 60601-2-
43:2010/AMD1:2017, the following new references:
[23] National Council on Radiation Protection and Measurements. Radiation Dose
Management for Fluoroscopically-Guided Interventional Medical Procedures. NCRP
Report 168, Bethesda, MD, 2010
[24] International Commission on Radiological Protection. Radiological Protection in
Cardiology, ICRP Publication 120, Ann. ICRP 42(1), 2013: 1-125
[25] Miller, D.L., Balter S., Dixon R.G., Nikolic B., Bartal G., Cardella J.F., Dauer L.T.,
Stecker M.S. Quality improvement guidelines for recording patient radiation dose in the
medical record for fluoroscopically guided procedures. J Vasc Interv Radiol, 2012,
23(1):11-18
[26] Chambers, C.E., Fetterly K.A., Holzer R., Lin P.J., Blankenship J.C., Balter S., Laskey
W.K. Radiation safety program for the cardiac catheterization laboratory. Catheter
Cardiovasc Interv, 2011. 77(4):546-556
[27] Stecker M.S., Balter S., Towbin R.B., Miller D.L., Vano E., Bartal G., Angle J.F., Chao
C.P., Cohen A.M., Dixon R.G., Gross K., Hartnell G.G., Schueler B., Statler J.D., de
Baère T., Cardella J.F. Guidelines for patient radiation dose management. J Vasc Interv
Radiol. 2009;20(7S):S263-S273
[28] Duran A., Hian S.K., Miller D.L., Le Heron J., Padovani R., Vano E. Recommendations
for occupational radiation protection in interventional cardiology. Catheter Cardiovasc
Interv. 2013, 82:29-42
[29] Miller D.L., Balter S., Noonan P.T., Georgia J.D. Minimizing radiation-induced skin injury
in interventional radiology procedures. Radiology, 2002, 225(2):329-336
[30] Kimpe T., Rostang J., Van Hoey G., Xthona A. Color standard display function: A
proposed extension of DICOM GSDF. Med. Phys., 2016, 43:5009-5019
[31] 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
[32] 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
[33] 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
[34] 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
[35] 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
– 16 – IEC 60601-2-43:2010/AMD2:2019
 IEC 2019
Index of defined terms used in this particular standard
Delete the following existing term and its reference:
ORIGINAL DATA . IEC 62220-1-1:2015, 3.13
Add the following new terms and their references:
ABSORBED DOSE . IEC TR 60788:2004, rm-13-08
AUTOMATIC CONTROL SYSTEM . IEC 60601-1-3:2008, 3.9
BEAM LIMITING DEVICE . IEC 60601-1-3:2008, 3.11
DOSE MAP . 201.3.205
EXAMINATION PROTOCOL . IEC 60601-2-54:2009/AMD2:2018,201.3.210
FIXED . IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.30
LAST IMAGE HOLD RADIOGRAM (LIH RADIOGRAM) . IEC 60601-2-54:2009/AMD2:2018,201.3.212
MOBI
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