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

Name:IEC 60601-2-43:2010   Standard name:Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Standard number:IEC 60601-2-43:2010   language:English and French language
Release Date:15-Oct-2019   technical committee:SC 62B - Medical imaging equipment, software, and systems
Drafting committee:   ICS number:01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION

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
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.

– 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 smal
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