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 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.

Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für interventionelle Verfahren

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.

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

• Status: Published
• Publication Date: 10-Jun-2010
• Withdrawal Date: 31-May-2013
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Jun-2010
• Completion Date: 11-Jun-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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)

Relations

• Replaces: EN 60601-2-43:2000 - Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-43:2023 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 22-Jan-2023
• Amended By: EN 60601-2-43:2010/A2:2020 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 22-Jan-2023
• Amended By: EN 60601-2-43:2010/A1:2018 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 22-Jan-2023
• Corrected By: EN 60601-2-43:2010/AC:2014 - Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
• Effective Date: 09-Jul-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2010
1DGRPHãþD
SIST EN 60601-2-43:2002
SIST EN 60601-2-54:2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
__________
- 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
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.
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
– 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
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 recommendation
...