IEC 60601-2-43:2010
(Main)Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
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 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration.
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d'interventions
La CEI 60601-2-43:2010 établit des exigences particulières de sécurité de base et de performances essentielles pour la conception et la fabrication des appareils à rayonnement X pour les interventions guidées par radioscopie. Elle spécifie les informations qui doivent être fournies avec de tels appareils à rayonnement X d'intervention pour aider l'organisme responsable et l'opérateur à gérer le risque de rayonnement et le risque de défaillance des équipements découlant de ces interventions et qui pourrait affecter les patients ou le personnel. Cette deuxième édition annule et remplace la première édition publiée en 2000. La présente norme particulière a été révisée pour fournir un ensemble complet d'exigences de sécurité pour les appareils à rayonnement X pour les interventions guidées par radioscopie; ces exigences sont fondées sur la troisième édition de la CEI 60601-1 et sur ses normes collatérales. La présente édition a été élargie pour devenir une norme système pour les appareils à rayonnement X conçus pour être employés au cours des interventions utilisant l'imagerie à rayonnement X qu'elles soient d'une durée normale ou prolongée.
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IEC 60601-2-43 ®
Edition 2.0 2010-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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IEC 60601-2-43 ®
Edition 2.0 2010-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.40.50; 37.040.25 ISBN 978-2-88910-223-5
– 2 – 60601-2-43 © IEC:2010
CONTENTS
FOREWORD.3
INTRODUCTION.6
201.1 Scope, object and related standards .7
201.2 Normative references.9
201.3 Terms and definitions.9
201.4 General requirements.10
201.5 General requirements for testing of ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .12
201.7 ME EQUIPMENT identification, marking and documents.12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS.17
201.11 Protection against excessive temperatures and other HAZARDS.17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.19
201.13 HAZARDOUS SITUATIONS and fault conditions.22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22
201.15 Construction of ME EQUIPMENT .22
201.16 ME SYSTEMS .23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .23
202 Electromagnetic compatibility – Requirements and tests .23
203 Radiation protection in diagnostic X-ray equipment .24
Annexes .34
Annex AA (informative) Particular guidance and rationale.35
Annex BB (normative) Distribution maps of STRAY RADIATION.43
Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43 and
Edition 1 .47
Bibliography.49
Index of defined terms used in this particular standard.51
Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration .
Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration.46
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
by MANUFACTURER in the RISK MANAGEMENT analysis.10
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS .15
Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES for which deterministic effects of IRRADIATION are possible .35
Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
which deterministic effects are unlikely .36
60601-2-43 © IEC:2010 – 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
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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.
International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 2000. This edition
constitutes a technical revision.
This particular standard has been revised to provide a complete set of safety requirements for
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, based on the third
edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a
system standard for X-RAY EQUIPMENT designed for the use during interventional procedures
using X-ray imaging, whether of prolonged or normal duration.
– 4 – 60601-2-43 © IEC:2010
The text of this standard is based on the following documents:
FDIS Report on voting
62B/779/FDIS 62B/792/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
60601-2-43 © IEC:2010 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site 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.
– 6 – 60601-2-43 © IEC:2010
INTRODUCTION
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may 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 may be the
occurrence of deterministic injury when 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.
Interventional procedures of the type envisaged are well established in clinical fields such as:
– invasive cardiology;
– interventional RADIOLOGY;
– interventional neuroradiology.
These procedures also include many newly developing and emerging applications in a wide
range of medical and surgical specialities.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
which may not align with the provisions of this standard.
60601-2-43 © IEC:2010 – 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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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 in cross-sectional imaging mode (sometimes described as
CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2] . Additional
requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.
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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2)
Figures in square brackets refer to the Bibliography.
– 8 – 60601-2-43 © IEC:2010
201.1.2 Object
Replacement:
The object of this particular standard is:
– to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the
design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES, as defined in 201.3.203.
– to specify information which is to be provided with such INTERVENTIONAL X-RAY EQUIPMENT
for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the
RADIATION RISK and equipment failure RISK arising from these procedures which could
affect PATIENTS or staff.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203
respectively. IEC 60601-1-8 and IEC 60601-1-10 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 the general standard 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 the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
60601-2-43 © IEC:2010 – 9 –
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the Bibliography beginning on page 50.
Amendment:
IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance– Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-3:2008 Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
ray equipment
Addition:
IEC 60580, 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 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
NOTE 1 An index of defined terms is found beginning on page 51.
NOTE 2 The reference point labelled as ‘interventional reference point’ in Edition 1 is replaced by PATIENT
ENTRANCE REFERENCE POINT in this edition.
– 10 – 60601-2-43 © IEC:2010
Addition:
201.3.201
* IMAGE DISPLAY DELAY
during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-ray
LOADING used to create an image and the DISPLAY of this event on the image
201.3.202
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT FOR RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
201.3.203
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into
the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
treatment or diagnosis of the medical condition of the PATIENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Subclause 201.4.3 of IEC 60601-2-54:2009 applies, except as follows:
Addition:
The list in Table 201.101 of IEC 60601-2-54 is a list of potential ESSENTIAL PERFORMANCE to be
considered by MANUFACTURER in the RISK MANAGEMENT analysis.
NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of IEC 60601-2-54
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
(Accuracy of X-RAY TUBE CURRENT). This limitation is also valid for the ESSENTIAL PERFORMANCE list.
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table
201.101.
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
UPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
201.4.10.2 S
Subclause 201.4.10.2 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.4.101 * Recovery management
The time to recover a minimum set of functions for performing emergency RADIOSCOPY, after a
failure recoverable by the OPERATOR, shall be as short as reasonably practicable. The RISK
MANAGEMENT shall take into account the availability of emergency power supply in the
determination of the recovery time.
60601-2-43 © IEC:2010 – 11 –
When the recovery is complete, a reinitiation of IRRADIATION procedure shall be required to
further produce IRRADIATION.
The time to recover all functions, after a failure recoverable by the operator, shall be as short
as reasonably practicable. The RISK MANAGEMENT shall determine means of realization with
definition of the transition timing.
In case of failure recoverable by the OPERATOR, the instructions for use shall describe the
required procedure, which the OPERATOR must follow, to perform this recovery. The
instructions for use shall indicate:
– the time necessary to get the minimum set of functions for emergency RADIOSCOPY
operable;
– the time to get all the functions of the INTERVENTIONAL X-RAY EQUIPMENT operable.
When the system is in the emergency RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The minimum set of functions necessary for performing emergency RADIOSCOPY are called
“emergency functions” and include:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION which was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible
to the one which was used at the time of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the GANTRY;
– normal operation of tableside controls for all functions described above;
– normal operation of the IRRADIATION disabling switch (see 203.6.103);
– normal operation of the motion disabling switch (see subclause 201.9.2.3.1 in
IEC 60601-2-54);
– normal operation of anti-collision functions (see 201.9.2.4).
Compliance is checked by inspection of the RISK MANAGEMENT FILE and by functional tests.
NOTE 3 This item is an addition compared to the first edition of IEC 60601-2-43:2000.
201.4.102 * RADIATION dose documentation
NTERVENTIONAL X-RAY EQUIPMENT shall provide RADIATION dose structured reports (RDSR).
I
NOTE The Radiation Dose Structured Report (RDSR) is defined in the DICOM standard [23].
RDSR should be created and handled by the INTERVENTIONAL X-RAY EQUIPMENT according to
IEC/PAS 61910-1:2007 [24].
The method for testing the performance/accuracy of the RSDR shall be stated in the RISK
MANAGEMENT FILE.
Compliance is checked by functional test and the RISK MANAGEMENT FILE, if applicable.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
– 12 – 60601-2-43 © IEC:2010
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME QUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Subclause 201.7.2.7 of IEC 60601-2-54:2009 applies.
201.7.2.15 Cooling conditions
Subclause 201.7.2.15 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.7.2.101 Beam limiting device
Subclause 201.7.2.101 of IEC 60601-2-54:2009 applies.
201.7.2.102 * PATIENT SUPPORT load
The PATIENT SUPPORT shall be marked with the maximum permissible mass in kilograms for
NORMAL USE, excluding use for cardiopulmonary resuscitation (CPR).
SAFE WORKING LOAD minus the CPR loading (see
This maximum permissible mass shall be the
201.9.8.3.1 for CPR loading value).
201.7.2.103 Cardiopulmonary resuscitation (CPR)
The PATIENT SUPPORT shall be marked with abbreviated instructions on configuring the
INTERVENTIONAL X-RAY EQUIPMENT for CPR.
201.7.2.104 Marking of compliance
INTERVENTIONAL X-RAY EQUIPMENT, compliance with this standard is to be marked on the
If, for
outside of the INTERVENTIONAL X-RAY EQUIPMENT, the marking shall be made in combination
with the MODEL OR TYPE REFERENCE as follows:
INTERVENTIONAL X-RAY EQUIPMENT [model or type reference] IEC 60601-2-43:2010.
201.7.2.105 * Protection against ingress of liquids
Specific parts of the INTERVENTIONAL X-RAY EQUIPMENT, which are located in the PATIENT
vicinity (or around the PATIENT), shall be marked with the degree of protection as defined in
IEC 60529. When an ACCESSORY is required for protection against ingress of liquids, this shall
be stated in the instructions for use.
NOTE 1 This is an addition compared to the first edition of IEC 60601-2-43:2000.
NOTE 2 See also 201.11.6.5.103.
60601-2-43 © IEC:2010 – 13 –
201.7.8.1 Colours of indicator lights
The indication of X-RAY related states shall be excluded from subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain quality control procedures to be performed on
the INTERVENTIONAL X-RAY EQUIPMENT by the RESPONSIBLE ORGANIZATION. These shall include
acceptance criteria and frequency for the tests.
Additionally for INTERVENTIONAL X-RAY EQUIPMENT provided with an integrated digital X-RAY
IMAGE RECEPTOR, the ACCOMPANYING DOCUMENTS shall contain:
– the identification of the version of image processing applied to ORIGINAL DATA;
NOTE Information displayed on the user interface can be considered to satisfy this requirement.
– a description of the file transfer format of the images acquired with this unit and of any
data associated with these images;
The performance of means required to present the images for diagnostic purpose shall be
stated according to the INTENDED USE.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Subclause 201.7.9.2.1 of IEC 60601-2-54:2009 applies.
201.7.9.2.12 * Cleaning, disinfection and sterilization
Addition:
NOTE In order to satisfy subclause 11.6.6 of the general standard, the information given has to exclude
commonly used but possibly corrosive substances, such as sodium hypochlorite, if the use of such substances
would present a risk of damage to the parts of the INTERVENTIONAL X-RAY EQUIPMENT concerned.
Additional subclauses:
201.7.9.2.101 PROTECTIVE DEVICES and ACCESSORIES
A list shall be provided of PROTECTIVE DEVICES and ACCESSORIES recommended when the
INTERVENTIONAL X-RAY EQUIPMENT is employed for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES. There may be different lists for different types of procedures. The listing may
include PROTECTIVE DEVICES such as PROTECTIVE CLOTHING, recommended for use but not
forming part of the INTERVENTIONAL X-RAY EQUIPMENT.
201.7.9.2.102 * Provisions for CPR
Instructions shall be given for at least one method of configuring the INTERVENTIONAL X-RAY
EQUIPMENT to permit CPR including the use of any necessary ACCESSORIES provided with the
INTERVENTIONAL X-RAY EQUIPMENT. These instructions shall not call for the use of ACCESSORIES
that are not provided with the INTERVENTIONAL X-RAY EQUIPMENT.
– 14 – 60601-2-43 © IEC:2010
If instructions differ between NORMAL USE and in cases of SINGLE FAULT CONDITIONS, the
instructions shall be given for all appropriate cases.
NOTE This last sentence is an addition compared to the first edition of IEC 60601-2-43:2000.
201.7.9.2.103 * Emergency instructions
Emergency instructions shall be provided in non-electronic form, resistant to manipulation,
water damage and cleaning.
Emergency instructions shall contain only instructions related to emergency functions and
situations.
At minimum, emergency instructions shall include instructions for:
• configuring the INTERVENTIONAL X-RAY EQUIPMENT for CPR (only for INTERVENTIONAL X-RAY
EQUIPMENT including a PATIENT SUPPORT) (201.7.9.2.102);
• the re-starting procedure in case of recoverable failure by the OPERATOR (201.4.101);
• the re-starting procedure for the INTERVENTIONAL X-RAY EQUIPMENT in the event of failure of
SUPPLY MAINS(201.7.9.2.104);
• the re-starting procedure for the INTERVENTIONAL X-RAY EQUIPMENT in the case of the use of
an emergency power supply requiring such actions (201.7.9.2.104);
• the location, function and operation of the IRRADIATION disabling switch (203.5.2.4.101);
• the location, function and operation of the motion disabling switch (see 201.9.2.3.1 of
IEC 60601-2-54);
• the list of emergency functions, as defined in 201.4.101;
• if the complete instructions for use are only available in electronic form, instructions for
accessing the complete instructions for use.
NOTE This is an addition compared to the first edition of IEC 60601-2-43:2000.
201.7.9.2.104 Failure of supply mains
The instructions for use shall describe the functional response and re-starting procedure for
the INTERVENTIONAL X-RAY EQUIPMENT in the event of failure of the SUPPLY MAINS. Details shall
be given of the possibilities for provisions being made in the installation of emergency power
supply for the following cases:
– for the preservation of stored images only;
– for emergency RADIOSCOPY (as described in 201.4.101);
– for minimum equipment motion (limited motion of GANTRY, table and source-to-image
motion as determined by the MANUFACTURER);
– for all functions for performing RADIOSCOPY and RADIOGRAPHY.
– for placing the INTERVENTIONAL X-RAY EQUIPMENT in CPR position in case of the failure of
SUPPLY MAINS, if placing the INTERVENTIONAL X-RAY EQUIPMENT IN CPR configuration
requires electrical power.
This information is necessary so that the RESPONSIBLE ORGANIZATION is able to decide on an
appropriate level of protection to be provided against such failures.
Compliance is determined by inspection of the instructions for use.
NOTE See 201.12.4.101.4 for requirements on indications of emergency power supply mode. See also
201.12.4.108 for requirements on operation of the emergency power supply.
60601-2-43 © IEC:2010 – 15 –
201.7.9.2.105 Description of the protection against ingress of liquids
The instructions for use shall explain the IPXY marking used on the INTERVENTIONAL X-RAY
EQUIPMENT.
NOTE 1 See also 201.7.2.105.
NOTE 2 This is an addition compared to the first edition of IEC 60601-2-43:2000.
201.7.9.3 Technical Description
Additional subclauses:
201.7.9.3.101 X-RAY SOURCE ASSEMBLY
Subclause 201.7.9.3.101 of IEC 60601-2-54:2009 applies.
201.7.9.3.102 Installation
For PERMANENTLY INSTALLED INTERVENTIONAL X-RAY EQUIPMENT, the technical description shall
contain the following recommendations concerning the installation of the INTERVENTIONAL X-
RAY EQUIPMENT:
– INTERLOCKS must not be present on the doors of the room containing the INTERVENTIONAL
X-RAY EQUIPMENT. No other measures, whether or not employed for RADIATION PROTECTION,
should be able to cause the interruption of IRRADIATION or any other disturbance of a
procedure in progress, unless the OPERATOR has the means to prevent such action from
occurring during the procedure;
– all emergency stop controls in the system must be protected against accidental actuation;
– sufficient space must be available around the PATIENT SUPPORT for the unimpeded conduct
of CPR;
– one or more warning lights must be present in order to indicate the LOADING STATE to
persons at all positions in the room containing the INTERVENTIONAL X-RAY EQUIPMENT; see
also requirement of 203.13.4
– appropriate warning lights to indicate the LOADING STATE must be present adjacent to
doors opening into the procedure room when warning lights within the procedure room are
not visible.
NOTE This list is a set of information for the RESPONSIBLE ORGANIZATION, therefore the verb ‘must’ is used to
clearly distinguish these from requirements on the INTERVENTIONAL X-RAY EQUIPMENT itself.
Additional subclauses:
ACCOMPANYING DOCUMENTS
201.7.9.101 Additional statements in
Additional requirements for statements in ACCOMPANYING DOCUMENTS (which include
instructions for use and technical description) are found in the subclauses listed in Annex C
Table 201.C.102 of IEC 60601-2-54:2009 and in Table 201.102 of this particular standard.
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS
Subclause Heading
201.4.101 Recovery management
201.7.2.105 Protection against ingress of liquids
201.9.8.3.1 Strength of PATIENT or OPERATOR support or suspension systems – General
201.11.6.1 Overflow, spillage, etc. – General
201.11.6.5.102 Sources of dust and other particles
201.12.4.101.2 Management of image storage capacity
– 16 – 60601-2-43 © IEC:2010
Subclause Heading
201.12.4.102 IMAGE DISPLAY DELAY
201.12.4.107 Measuring functions
201.15.102 Attachment of sterile drapes
203.5.2.4.5 Deterministic effects
203.5.2.4.101 IRRADIATION disabling switch
203.6.4.2 Indication of LOADING STATE
203.13.4 Designated SIGNIFICANT ZONES OF OCCUPANCY
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
Replacement:
Clause 201.8 of IEC 60601-2-54:2009 applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
AZARDS associated with moving parts
201.9.2 H
201.9.2.2.4 GUARDS and protective measures
Subclause 201.9.2.2.4 of IEC 60601-2-54:2009 applies.
201.9.2.2.5 Continuous activation
Subclause 201.9.2.2.5 of IEC 60601-2-54:2009 applies.
201.9.2.2.6 Speed of movement(s)
Subclause 201.9.2.2.6 of IEC 60601-2-54:2009 applies.
201.9.2.3 Other HAZARDS associated with moving parts
Subclause 201.9.2.3 of IEC 60601-2-54:2009 applies.
201.9.2.4 * Emergency stopping devices
Addition:
aa) In order to prevent HAZARDS arising from the unintended interruption of RADIOSCOPICALLY
GUIDED INTERVENTIONAL PROCEDURES, the operation of anti-collision devices in
INTERVENTIONAL X-RAY EQUIPMENT shall not automatically switch off IRRADIATION and shall
not impair other functions of the INTERVENTIONAL X-RAY EQUIPMENT, except movements
connected with the potential collision. Means shall be provided for any movement
disabled by the actuation of an anti-collision device to be caused to recover from collision
within 5 s after a positive action taken at the working position of the OPERATOR.
Additional subclause:
60601-2-43 © IEC:2010 – 17 –
201.9.2.4.101 Controls
Subclause 201.9.2.4.101 of IEC 60601-2-54:2009 applies.
201.9.8 HAZARDS associated with support systems
201.9.8.3 Strength of patient or operator support or suspension systems
201.9.8.3.1 General
Addition:
In INTERVENTIONAL X-RAY EQUIPMENT, the load for which the PATIENT SUPPORT is designed shall
be the normal load imposed by the PATIENT (as specified and marked, or otherwise as
required in this subclause), with the addition of a mass of not less than 50 kg to provide for
additional load imposed in the performance of CPR. This additional load shall be assumed to
be applied uniformly over a length of 1 500 mm from the head-end of the PATIENT SUPPORT, or
over the whole length if it is less than 1 500 mm, when the INTERVENTIONAL X-RAY EQUIPMENT
is configured for CPR in accordance with the instructions for use, including the fitting of any
ACCESSORIES specified for use in CPR.
Addition to the description of the compliance test:
For INTERVENTIONAL X-RAY EQUIPMENT, the test shall be carried out in the least favourable
position other than when configured for CPR, and also in the least favourable position when
configured for CPR. When configured for CPR, the test shall include the application of
additional weight evenly over the portion of the PATIENT SUPPORT from the head-end up to a
length of 1 500 mm or the maximum available length if less than 1 500 mm. This additional
weight shall be applied after an interval of 1
...
IEC 60601-2-43 ®
Edition 2.1 2017-05
CONSOLIDATED VERSION
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
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IEC 60601-2-43 ®
Edition 2.1 2017-05
CONSOLIDATED VERSION
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 978-2-8322-4448-7
IEC 60601-2-43 ®
Edition 2.1 2017-05
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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
– 2 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to the Amendment . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 12
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 . 17
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 . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic compatibility disturbances – Requirements and tests . 25
203 Radiation protection in diagnostic X-ray equipment . 25
Annexes . 36
Annex AA (informative) Particular guidance and rationale . 37
Annex BB (normative) Distribution maps of STRAY RADIATION . 45
Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43
and Edition 1 . 49
Bibliography . 51
Index of defined terms used in this particular standard. 53
Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration . 47
Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration . 48
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
by 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 . 37
Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
for which deterministic effects are unlikely . 38
IEC 2017
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
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This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-43 edition 2.1 contains the second edition (2010-03) [documents 62B/779/FDIS and
62B/792/RVD] and its amendment 1 (2017-05) [documents 62B/1012/CDV and 62B/1037/RVC].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions are in green text, deletions are in strikethrough red text.
A separate Final version with all changes accepted is available in this publication.
– 4 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition constitutes a technical revision.
This particular standard has been revised to provide a complete set of safety requirements for
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, based on the third
edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a
system standard for X-RAY EQUIPMENT designed for the use during interventional procedures
using X-ray imaging, whether of prolonged or normal duration.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
IEC 2017
The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability date indicated on the IEC web site 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.
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understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
INTRODUCTION
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may 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 may be the
occurrence of deterministic injury when 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.
Interventional procedures of the type envisaged are well established in clinical fields such as:
– invasive cardiology;
– interventional RADIOLOGY;
– interventional neuroradiology.
These procedures also include many newly developing and emerging applications in a wide
range of medical and surgical specialities.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
which may not align with the provisions of this standard.
INTRODUCTION to the Amendment
The purpose of this first amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– refer to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its applicable collateral
standards;
– refer to IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 and consequent
subclause adaptations;
– include a requirement to have a maximum time of 10 min to recover all functions after a
recoverable failure in 201.4.101;
– include several aspects from IEC 61910-1:2014 and remove the reference to
IEC PAS 61910-1:2007 in 201.4.102;
– include an alternative way of testing in 201.11.6.5.103;
– include a clarification for tableside controls in 201.12.4.106.
In addition, a number of technical errors have been corrected.
IEC 2017
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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 in cross-sectional imaging mode (sometimes described as
CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2] . Additional
requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.
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
only, or to ME SYSTEMS only, the title and content of that clause or subclause will
EQUIPMENT
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.
—————————
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
2)
Figures in square brackets refer to the Bibliography.
– 8 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
201.1.2 Object
Replacement:
The object of this particular standard is:
– to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the
design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES, as defined in 201.3.203.
– to specify information which is to be provided with such INTERVENTIONAL X-RAY EQUIPMENT
for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the
RADIATION RISK and equipment failure RISK arising from these procedures which could
affect PATIENTS or staff.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203
3) 4) 5)
respectively. IEC 60601-1-8, IEC 60601-1-10 , IEC 60601-1-11 and IEC 60601-1-12 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 the general standard 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 the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
—————————
3) 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
4)
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
5) 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
IEC 2017
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the Bibliography beginning on page 52.
Amendment:
IEC 60601-1-2:2007 2014 Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
ray equipment
IEC 60601-1-3:2008/AMD1:2013
Addition:
IEC 60580, Medical electrical equipment – Dose area product meters
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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
– 10 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008, IEC 60601-2-54:2009,
IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the following apply, except
as follows.
NOTE 1 An index of defined terms is found beginning on page 53.
NOTE 2 The reference point labelled as ‘interventional reference point’ in Edition 1 is replaced by PATIENT
ENTRANCE REFERENCE POINT in this edition.
Addition:
201.3.201
* IMAGE DISPLAY DELAY
during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-ray
LOADING used to create an image and the DISPLAY of this event on the image
201.3.202
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT FOR RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
201.3.203
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into
the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
treatment or diagnosis of the medical condition of the PATIENT
201.3.204
EMERGENCY RADIOSCOPY
RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Subclause 201.4.3 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 applies,
except as follows:
Addition:
IEC 2017
The list in Table 201.101 of IEC 60601-2-54 is a list of potential ESSENTIAL PERFORMANCE to be
considered by MANUFACTURER in the RISK MANAGEMENT analysis.
NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of IEC 60601-2-54
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
(Accuracy of X-RAY TUBE CURRENT). This limitation is also valid for the ESSENTIAL PERFORMANCE list.
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table
201.101.
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
UPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
201.4.10.2 S
Subclause 201.4.10.2 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.4.101 * Recovery management
The time to recover a minimum set all of the functions necessary for performing EMERGENCY
RADIOSCOPY, after a failure recoverable automatically or by the OPERATOR shall be as short as
reasonably practicable. The RISK MANAGEMENT shall take into account the availability of
emergency power supply in the determination of the recovery time.
When the recovery is complete, a reinitiation of IRRADIATION procedure shall be required to
further produce further IRRADIATION.
The time to recover all functions, after a failure recoverable automatically or by the operator,
shall be as short as reasonably practicable. The RISK MANAGEMENT shall determine means of
realization with definition of the transition timing.
In case of failure recoverable by the OPERATOR, the instructions for use shall describe the
required procedure, which the OPERATOR must follow, to perform this recovery.
In case of a manually recoverable failure, the time to recover all functions shall not exceed
10 min from the time the OPERATOR has initiated the recovery to the time the INTERVENTIONAL
X-RAY EQUIPMENT has all functions available.
In case of an automatically detected and automatically recoverable failure, the time to recover
all functions shall not exceed 10 min from the time of the failure of the INTERVENTIONAL X-RAY
EQUIPMENT to the time the INTERVENTIONAL X-RAY EQUIPMENT has all functions available.
INTERVENTIONAL X-RAY EQUIPMENT may have both recovery modes.
NOTE Less than 1 min is a desirable value for the time to recover all functions for performing EMERGENCY
RADIOSCOPY. Less than 3 min is a desirable value to recover all functions.
The instructions for use shall indicate:
– the time necessary to get the minimum set of all functions for EMERGENCY RADIOSCOPY
operable;
– the time to get restore all the functions of the INTERVENTIONAL X-RAY EQUIPMENT operable;
– 12 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
– for failures recoverable by the OPERATOR, the required procedure which the OPERATOR
must follow to perform this recovery.
When the system is in the EMERGENCY RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The minimum set of functions necessary for performing EMERGENCY RADIOSCOPY are called
“emergency functions” and shall include, at minimum:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION that was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible
to the one which was used at the time of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the GANTRY;
– normal operation of tableside controls for all functions described above;
– normal operation of the IRRADIATION disabling switch (see 203.6.103);
– normal operation of the motion disabling switch (see 201.9.2.3.1 in IEC 60601-2-54:2009
and IEC 60601-2-54:2009/AMD1:2015);
– normal operation of anti-collision functions (see 201.9.2.4).
Compliance is checked by inspection of the RISK MANAGEMENT FILE and by functional tests.
NOTE 3 This item is an addition compared to the first edition of IEC 60601-2-43:2000.
201.4.102 * RADIATION dose documentation
The INTERVENTIONAL X-RAY EQUIPMENT shall provide create RADIATION DOSE STRUCTURED
REPORTS (RDSR) and shall have the ability to perform RDSR END OF PROCEDURE TRANSMISSION.
NOTE The Radiation Dose Structured Report (RDSR) is defined in the DICOM standard [23].
RDSR should be created and handled by the INTERVENTIONAL X-RAY EQUIPMENT according to
IEC/PAS 61910-1:2007 [24].
The method for testing the performance/accuracy of the RSDR shall be stated in the RISK
MANAGEMENT FILE.
The RDSR shall contain the data elements that are required (‘shall’) in 5.1.2 and 5.1.3 of
IEC 61910-1:2014.
The RDSR should contain the data elements that are recommended (‘should’) in 5.1.2 and
5.1.3 of IEC 61910-1:2014.
NOTE The conditional statements associated with the data elements in IEC 61910-1:2014 are considered to be
part of these data elements.
If the INTERVENTIONAL X-RAY EQUIPMENT does not have means to determine GANTRY
angulations, the RDSR need not contain the data elements related to positioner angles.
Compliance is checked by functional test and the RISK MANAGEMENT FILE, if applicable.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
IEC 2017
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME QUIPMENT or ME EQUIPMENT parts
201.7.2.7 Electrical input power from the SUPPLY MAINS
Subclause 201.7.2.7 of IEC 60601-2-54:2009 applies.
201.7.2.15 Cooling conditions
Subclause 201.7.2.15 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.7.2.101 Beam limiting device
Subclause 201.7.2.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015
applies.
201.7.2.102 * PATIENT SUPPORT load
The PATIENT SUPPORT shall be marked with the maximum permissible mass in kilograms for
NORMAL USE, excluding use for cardiopulmonary resuscitation (CPR).
This maximum permissible mass shall be the SAFE WORKING LOAD minus the CPR loading (see
201.9.8.3.1 for CPR loading value).
201.7.2.103 Cardiopulmonary resuscitation (CPR)
The PATIENT SUPPORT shall be marked with abbreviated instructions on configuring the
INTERVENTIONAL X-RAY EQUIPMENT for CPR.
201.7.2.104 Marking of compliance
If, for INTERVENTIONAL X-RAY EQUIPMENT, compliance with this standard is to be marked on the
outside of the INTERVENTIONAL X-RAY EQUIPMENT, the marking shall be made in combination
with the MODEL OR TYPE REFERENCE as follows:
INTERVENTIONAL X-RAY EQUIPMENT [model or type reference] IEC 60601-2-43:2010.
201.7.2.105 * Protection against ingress of liquids
Specific parts of the INTERVENTIONAL X-RAY EQUIPMENT, which are located in the PATIENT
vicinity (or around the PATIENT), shall be marked with the degree of protection as defined in
IEC 60529. When an ACCESSORY is required for protection against ingress of liquids, this shall
be stated in the instructions for use.
NOTE 1 This is an addition compared to the first edition of IEC 60601-2-43:2000.
NOTE 2 See also 201.11.6.5.103.
NOTE 3 Parts that are IPX0 need not be marked.
– 14 – IEC 60601-2-43:2010+AMD1:2017 CSV
IEC 2017
201.7.8.1 Colours of indicator lights
The indication of X-RAY related states shall be excluded from subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain quality control procedures to be performed on
the INTERVENTIONAL X-RAY EQUIPMENT by the RESPONSIBLE ORGANIZATION. These shall include
acceptance criteria and frequency for the tests.
Additionally for INTERVENTIONAL X-RAY EQUIPMENT provided with an integrated digital X-RAY
IMAGE RECEPTOR, the ACCOMPANYING DOCUMENTS shall contain:
– the identification of the version of image processing applied to ORIGINAL DATA;
NOTE Information displayed on the user interface can be considered to satisfy this requirement.
– a description of the file transfer format of the images acquired with this unit and of any
data associated with these images;
The performance of means required to present the images for diagnostic purpose shall be
stated according to the INTENDED USE.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Subclause 201.7.9.2.1 of IEC 60601-2-54:2009 applies.
201.7.9.2.12 * Cleaning, disinfection and sterilization
Addition:
NOTE In order to satisfy subclause 11.6.6 of the general standard, the information given has to exclude
commonly used but possibly corrosive substances, such as sodium hypochlorite, if the use of such substances
would present a risk of damage to the parts of the INTERVENTIONAL X-RAY EQUIPMENT concerned.
201.7.9.2.17 ME EQUIPMENT emitting radiation
Subclause 201.7.9.2.17 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015
applies.
Additional subclauses:
201.7.9.2.101 PROTECTIVE DEVICES and ACCESSORIES
A list shall be provided of PROTECTIVE DEVICES and ACCESSORIES recommended when the
INTERVENTIONAL X-RAY EQUIPMENT is employed for RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES. There may be different lists for different types of procedures. The listing may
include PROTECTIVE DEVICES such as PROTECTIVE CLOTHING, recommended for use but not
forming part of the INTERVENTIONAL X-RAY EQUIPMENT.
IEC 2017
201.7.9.2.102 * Provisions for CPR
Instructions shall be given for at least one method of configuring the INTERVENTIONAL X-RAY
EQUIPMENT to permit CPR including the use of any necessary ACCESSORIES provided with the
INTERVENTIONAL X-RAY EQUIPMENT. These instructions shall not call for the use of ACCESSORIES
that are not provided with the INTERVENTIONAL X-RAY EQUIPMENT.
If instructions differ between NORMAL USE and in cases of SINGLE FAULT CONDITIONS, the
instructions shall be given for all appropriate cases.
NOTE This last sentence is an addition compared to the first edition of IEC 60601-2-43:2000.
201.7.9.2.103 * Emergency instructions
Emergency instructions shall be provided in non-electronic form, resistant to manipulation,
water damage and cleaning.
Emergency instructions shall contain only instructions related to emergency functions and
situations.
At minimum, emergency instructions shall include instructions for:
• configuring the INTERVENTIONAL X-RAY EQUIPMENT for CPR (only for INTERVENTIONAL X-RAY
EQUIPMENT including a PATIENT SUPPORT) (201.7.9.2.102);
• the re-starting procedure in case of recoverable failure by the OPERATOR (201.4.101);
• the re-starting procedure for the INTERVENTIONAL X-RAY EQUIPMENT in the event of failure of
SUPPLY MAINS(201.7.9.2.104);
• the re-starting procedure for the INTERVENTIONAL X-RAY EQUIPMENT in the case of the use of
an emergency power supply re
...
IEC 60601-2-43 ®
Edition 2.2 2019-10
CONSOLIDATED VERSION
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
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IEC 60601-2-43 ®
Edition 2.2 2019-10
CONSOLIDATED VERSION
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 ISBN 978-2-8322-7532-0
IEC 60601-2-43 ®
Edition 2.2 2019-10
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
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
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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 12
201.4 General requirements . 13
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions . 27
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
201.15 Construction of ME EQUIPMENT . 27
201.16 ME SYSTEMS . 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
202 Electromagnetic compatibility disturbances – Requirements and tests . 28
203 Radiation protection in diagnostic X-ray equipment . 29
Annexes . 42
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (normative) Distribution maps of STRAY RADIATION . 55
Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43
and Edition 1 . 58
Bibliography . 60
Index of defined terms used in this particular standard. 63
Figure BB.1 – Example of isokerma map at 100 cm height in lateral configuration . 56
Figure BB.2 – Example of isokerma map at 100 cm height in vertical configuration . 57
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered
by MANUFACTURER in the RISK MANAGEMENT analysis . 13
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS . 20
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 29
Table AA.1 – Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL
PROCEDURES for which deterministic effects of IRRADIATION are possible . 43
Table AA.2 – Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
which deterministic effects are unlikely . 44
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Table AA.3 – Examples of isodose boundaries and colour codes for SKIN DOSE MAP and
air kerma map . 53
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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 Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for 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
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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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other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-43 edition 2.2 contains the second edition (2010-03) [documents 62B/779/
FDIS and 62B/792/RVD], its amendment 1 (2017-05) [documents 62B/1012/CDV and
62B/1037/RVC] and its amendment 2 (2019-10) [documents 62B/1137/FDIS and 62B/1146/
RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
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International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition constitutes a technical revision.
This particular standard has been revised to provide a complete set of safety requirements for
RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, based on the third
X-
edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a
system standard for X-RAY EQUIPMENT designed for the use during interventional procedures
using X-ray imaging, whether of prolonged or normal duration.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
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The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the stability date indicated on the IEC web site 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.
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INTRODUCTION
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may 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 may be the
occurrence of deterministic injury when 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.
Interventional procedures of the type envisaged are well established in clinical fields such as:
– invasive cardiology;
– interventional RADIOLOGY;
– interventional neuroradiology.
These procedures also include many newly developing and emerging applications in a wide
range of medical and surgical specialities.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIOLOGICAL PROTECTION,
which may not align with the provisions of this standard.
INTRODUCTION to Amendment 1
The purpose of this first amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– refer to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its applicable collateral
standards;
– refer to IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 and consequent
subclause adaptations;
– include a requirement to have a maximum time of 10 min to recover all functions after a
recoverable failure in 201.4.101;
– include several aspects from IEC 61910-1:2014 and remove the reference to
IEC PAS 61910-1:2007 in 201.4.102;
– include an alternative way of testing in 201.11.6.5.103;
– include a clarification for tableside controls in 201.12.4.106.
In addition, a number of technical errors have been corrected.
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;
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– 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;
– 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.
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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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
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 in cross-sectional imaging mode (sometimes described as
CT-like mode or cone-beam CT) for cone-beam CT mode, is covered by this particular standard and not by
IEC 60601-2-44 [2] . No additional requirements for operation in CT-like mode or cone-beam CT mode were not
considered in the present 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.
—————————
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 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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201.1.2 Object
Replacement:
The object of this particular standard 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 201.3.203.
– to specify information which is to 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 procedures which could
affect PATIENTS or staff.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203
3 ) 4 ) 5 ) 6 )
respectively. IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 and
7)
IEC 60601-1-12 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 the general standard 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 the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
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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standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the Bibliography beginning on page 61.
Amendment:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
IEC 60601-1-2:20072014 Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
ray equipment
IEC 60601-1-3:2008/AMD1:2013
Addition:
IEC 60580:2000, Medical electrical equipment – Dose area product meters
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IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61910-1:2014, Medical electrical equipment – Radiation dose documentation – Part 1:
Radiation dose structured reports for radiography and radioscopy
IEC 62220-1:2003, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1: Determination of the detective quantum efficiency
IEC 62220-1-1:2015, Medical electrical equipment – Characteristics of digital X-ray imaging
devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in
radiographic imaging
201.3 Terms and definitions
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, except as follows.
NOTE 1 An index of defined terms is found beginning on page 63.
NOTE 2 The reference point labelled as ‘interventional reference point’ in Edition 1 is replaced by PATIENT
ENTRANCE REFERENCE POINT in this edition.
Addition:
201.3.201
* IMAGE DISPLAY DELAY
during RADIOSCOPY or RADIOGRAPHY, time delay between an event captured during an X-ray
LOADING used to create an image and the DISPLAY of this event on the image
201.3.202
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT FOR RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
201.3.203
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into
the PATIENT) using RADIOSCOPY as the principal means of guidance, and intended to effect
treatment or diagnosis of the medical condition of the PATIENT
201.3.204
EMERGENCY RADIOSCOPY
RADIOSCOPY with availability of a limited set of functions (emergency functions), for use during
recovery from a recoverable failure of the INTERVENTIONAL X-RAY EQUIPMENT
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201.3.205
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.206
SKIN DOSE
ABSORBED DOSE to the skin at a specific point
estimated
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Subclause 201.4.3 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015 applies,
except as follows:
Addition:
The list in Table 201.101 of IEC 60601-2-54 is a list of potential ESSENTIAL PERFORMANCE to be
considered by MANUFACTURER in the RISK MANAGEMENT analysis.
NOTE Subclause 203.6.4.3.104.2 (Accuracy of LOADING FACTORS in automatic control mode) of IEC 60601-2-54
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
(Accuracy of X-RAY TUBE CURRENT). This limitation is also valid for the ESSENTIAL PERFORMANCE list.
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table
201.101.
Table 201.101 – Additional list of potential ESSENTIAL PERFORMANCE to be considered by
MANUFACTURER in the RISK MANAGEMENT analysis
Requirement Subclause
Recovery management 201.4.101
RADIATION dose documentation 201.4.102
201.4.10.2 SUPPLY MAINS FOR ME EQUIPMENT and ME SYSTEMS
Subclause 201.4.10.2 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.4.101 * Recovery management
The time to recover a minimum set all of the functions necessary for performing EMERGENCY
RADIOSCOPY, after a failure recoverable automatically or by the OPERATOR shall be as short as
reasonably practicable. The RISK MANAGEMENT shall take into account the availability of
emergency power supply in the determination of the recovery time.
When the recovery is complete, a reinitiation of IRRADIATION procedure shall be required to
further produce further IRRADIATION.
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The time to recover all functions, after a failure recoverable automatically or by the operator,
shall be as short as reasonably practicable. The RISK MANAGEMENT shall determine means of
realization with definition of the transition timing.
In case of failure recoverable by the OPERATOR, the instructions for use shall describe the
required procedure, which the OPERATOR must follow, to perform this recovery.
In case of a manually recoverable failure, the time to recover all functions shall not exceed
10 min from the time the OPERATOR has initiated the recovery to the time the INTERVENTIONAL
X-RAY EQUIPMENT has all functions available.
In case of an automatically detected and automatically recoverable failure, the time to recover
all functions shall not exceed 10 min from the time of the failure of the INTERVENTIONAL X-RAY
EQUIPMENT to the time the INTERVENTIONAL X-RAY EQUIPMENT has all functions available.
NTERVENTIONAL X-RAY EQUIPMENT may have both recovery modes.
I
NOTE Less than 1 min is a desirable value for the time to recover all functions for performing EMERGENCY
RADIOSCOPY. Less than 3 min is a desirable value to recover all functions.
The instructions for use shall indicate:
– the time necessary to get the minimum set of all functions for EMERGENCY RADIOSCOPY
operable;
– the time to get restore all the functions of the INTERVENTIONAL X-RAY EQUIPMENT operable;
– for failures recoverable by the OPERATOR, the required procedure which the OPERATOR
must follow to perform this recovery.
When the system is in the EMERGENCY RADIOSCOPY mode, this mode shall be indicated at the
working position of the OPERATOR.
The minimum set of functions necessary for performing EMERGENCY RADIOSCOPY are called
“emergency functions” and shall include, at minimum:
– RADIOSCOPY MODE OF OPERATION, in priority order:
• RADIOSCOPY in the MODE OF OPERATION that was used at the time of the recoverable
equipment failure;
• or, if this is not possible, RADIOSCOPY in the MODE OF OPERATION as close as possible
to the one which was used at the time of the recoverable equipment failure;
– normal operation of the PATIENT SUPPORT;
– normal operation of the GANTRY;
– normal operation of tableside controls for all functions described above;
– normal operation of the IRRADIATION disabling switch (see 203.6.103);
– normal operation of the motion disabling switch (see 201.9.2.3.1 in IEC 60601-2-54:2009
and IEC 60601-2-54:2009/AMD1:2015);
– normal operation of anti-collision functions (see 201.9.2.4).
Compliance is checked by inspection of the RISK MANAGEMENT FILE and by functional tests.
NOTE 3 This item is an addition compared to the first edition of IEC 60601-2-43:2000.
201.4.102 * RADIATION dose documentation
The INTERVENTIONAL X-RAY EQUIPMENT shall provide create RADIATION DOSE STRUCTURED
REPORTS (RDSR) and shall have the ability to perform RDSR END OF PROCEDURE TRANSMISSION.
+AMD2:2019 CSV IEC 2019
NOTE The Radiation Dose Structured Report (RDSR) is defined in the DICOM standard [23].
RDSR should be created and handled by the INTERVENTIONAL X-RAY EQUIPMENT according to
IEC/PAS 61910-1:2007 [24].
The method for testing the performance/accuracy of the RSDR shall be stated in the RISK
MANAGEMENT FILE.
The RDSR shall contain the data elements that are required (‘shall’) in 5.1.2 and 5.1.3 of
IEC 61910-1:2014.
The RDSR should contain the data elements that are recommended (‘should’) in 5.1.2 and
5.1.3 of IEC 61910-1:2014.
NOTE The conditional statements associated with the data elements in IEC 61910-1:2014 are considered to be
part of these data elements.
If the INTERVENTIONAL X-RAY EQUIPMENT does not have means to determine GANTRY
angulations, the RDSR need not contain the data elements related to positioner angles.
The data elements shall be populated with the specified data.
Compliance is checked by appropriate inspection and functional test and the RISK
MANAGEMENT FILE, if applicable.
201.5 General requirements for testing of ME EQUIPMENT
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.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME QUIPMENT or ME EQUIPMENT parts
SUPPLY MAINS
201.7.2.7 Electrical input power from the
Subclause 201.7.2.7 of IEC 60601-2-54:2009 applies.
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+AMD2:2019 CSV IEC 2019
201.7.2.15 Cooling conditions
Subclause 201.7.2.15 of IEC 60601-2-54:2009 applies.
Additional subclauses:
201.7.2.101 Beam limiting device
Subclause 201.7.2.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD1:2015
applies.
201.7.2.102 * PATIENT SUPPORT load
The PATIENT SUPPORT shall be marked with the maximum permissible mass in kilograms for
NORMAL USE, excluding use for cardiopulmonary resuscitation (CPR).
This maximum permissible mass shall be the SAFE WORKING LOAD minus the CPR loading (see
201.9.8.3.1 for CPR loading value).
201.7.2.103 Cardiopulmonary resuscitation (CPR)
The PATIENT SUPPORT shall be marked with abbreviated instructions on configuring the
INTERVENTIONAL X-RAY EQUIPMENT for CPR.
201.7.2.104 Marking of compliance
If, for INTERVENTIONAL X-RAY EQUIPMENT, compliance with this standard is to be marked on the
outside of the INTERVENTIONAL X-RAY EQUIPMENT, the marking shall be made in combination
MODEL OR TYPE REFERENCE as follows:
with the
INTERVENTIONAL X-RAY EQUIPMENT [model or type reference] IEC 60601-2-43:2010, IEC 60601-
2-43:2010/AMD1:2017 and IEC 60601-2-43:2010/AMD2:2019.
201.7.2.105 * Protection against ingress of liquids
Specific parts of the INTERVENTIONAL X-RAY EQUIPMENT, which are located in the PATIENT
vicinity (or around the PATIENT), shall be marked with the degree of protection as defined in
IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013. When an
ACCESSORY is required for protection against ingress of liquids, this shall be stated in the
instructions for use.
NOTE 1 This is an addition compared to the first edition of IEC 60601-2-43:2000.
NOTE 2 See also 201.11.6.5.103.
NOTE 3 Parts that are IPX0 need not be marked.
201.7.8.1 Colours of indicator lights
The indication of X-RAY related states shall be excluded from subclause 7.8 in the general
standard. Subclauses 203.6.4.2 and 203.6.4.101 shall apply instead.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall contain quality con
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