SIST EN 60601-2-43:2010
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010)
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010)
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. 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.
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2010)
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d'interventions (CEI 60601-2-43:2010)
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.
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke (IEC 60601-2-43:2010)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RENGENTSKE OPREME, za katero PROIZVAJALEC navaja, da je primerna za RADIOSKOPSKO VODENE INTERVENTNE POSTOPKE, v nadaljevanju INTERVENTNE RENTGENSKE OPREME. Njeno področje uporabe izključuje zlasti: - opremo za RADIOTERAPIJO; opremo za RAČUNALNIŠKO TOMOGRAFIJO; - DODATKE, ki so namenjeni vstavitvi v PACIENTA; MAMOGRAFSKO OPREMO; zobno RENTGENSKO OPREMO. INTERVENCIJSKA RENTGENTSKA OPREMA, za katero PROIZVAJALEC navaja, da je primerna za RADIOSKOPSKO VODENE INTERVENCIJSKE POSTOPKE, ki ne vključuje PODPORE PACIENTU kot del sistema, je izvzeta iz določb tega standarda. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za INTERVENCIJSKO RENGENTSKO OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru, tako klavzula ali podklavzula veljata za ustrezno INTERVENCIJSKO RENTGENSKO OPREMO in ME SISTEME.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-43:2010
01-september-2010
1DGRPHãþD
SIST EN 60601-2-43:2002
SIST EN 60601-2-54:2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNHRSUHPH]DLQWHUYHQWQHSRVWRSNH ,(&
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and
essential performance of X-ray equipment for interventional procedures (IEC 60601-2-
43:2010)
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit
von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2010)
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X lors d'interventions (CEI
60601-2-43:2010)
Ta slovenski standard je istoveten z: EN 60601-2-43:2010
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-43:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-43:2010
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SIST EN 60601-2-43:2010
EUROPEAN STANDARD
EN 60601-2-43
NORME EUROPÉENNE
June 2010
EUROPÄISCHE NORM
ICS 11.040.50; 37.040.25 Supersedes EN 60601-2-43:2000, EN 60601-2-54:2009 (partially)
English version
Medical electrical equipment -
Part 2-43: Particular requirements for basic safety and essential
performance of X-ray equipment for interventional procedures
(IEC 60601-2-43:2010)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-43: Exigences particulières Teil 2-43: Besondere Festlegungen
pour la sécurité de base für die Sicherheit
et les performances essentielles von Röntgeneinrichtungen
des appareils à rayonnement X für interventionelle Verfahren
lors d'interventions (IEC 60601-2-43:2010)
(CEI 60601-2-43:2010)
This European Standard was approved by CENELEC on 2010-06-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-43:2010 E
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SIST EN 60601-2-43:2010
EN 60601-2-43:2010 - 2 -
Foreword
The text of document 62B/779/FDIS, future edition 2 of IEC 60601-2-43, prepared by SC 62B, Diagnostic
imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-43 on 2010-06-01.
This European Standard supersedes EN 60601-2-43:2000 and partially supersedes
EN 60601-2-54:2009.
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 EN 60601-1:2006 and
relevant collaterals. EN 60601-2-43:2010 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-06-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-43:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
[2] IEC 60601-2-44 NOTE Harmonized as EN 60601-2-44.
__________
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SIST EN 60601-2-43:2010
- 3 - EN 60601-2-43:2010
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Amendment:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
Addition:
IEC 60580 - Medical electrical equipment - Dose area EN 60580 -
product meters
IEC 60601-2-54 2009 Medical electrical equipment - EN 60601-2-54 2009
Part 2-54: Particular requirements for the
basic safety and essential performance of X-
ray equipment for radiography and radioscopy
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -
Part 1: Determination of the detective
quantum efficiency
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SIST EN 60601-2-43:2010
EN 60601-2-43:2010 - 4 -
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directives concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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SIST EN 60601-2-43:2010
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 2-8318-1086-4
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-43:2010
– 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
45
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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SIST EN 60601-2-43:2010
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
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
members of its technical committees and IEC National Committees for any personal injury, property damage or
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
Publications.
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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SIST EN 60601-2-43:2010
– 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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SIST EN 60601-2-43:2010
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.
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SIST EN 60601-2-43:2010
– 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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SIST EN 60601-2-43:2010
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
2
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.
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SIST EN 60601-2-43:2010
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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.
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SIST EN 60601-2-43:2010
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 REFE
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