IEC 60601-2-43:2010

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

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.

General Information

• Status: Published
• Publication Date: 24-Mar-2010
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 05-Dec-2022

Standards Content (Sample)

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
IEC 60601-2-43:2010
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
CODE PRIX
ICS 11.40.50; 37.040.25 ISBN 978-2-88910-223-5
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

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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

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

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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.
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– 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.
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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.
---------------------- Page: 7 ----------------------
– 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.
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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
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.
—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
Figures in square brackets refer to the Bibliography.
---------------------- Page: 9 ----------------------
– 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.

---------------------- Page: 10 ----------------------
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.
---------------------- Page: 11 ----------------------
– 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.
---------------------- Page: 12 ----------------------
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
...