IEC 60601-2-43:2000

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

Establishes safety requirements for the design and manufacture of X-ray equipment for prolonged radioscopically guided interventional procedures. Specifies information which is to be provided with such equipment for the assistance of the user and operator in managing the radiation risk arising from these procedures which could affect patients and staff.

General Information

• Status: Published
• Publication Date: 29-Jun-2000
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 24 - TC 62/SC 62B/WG 24
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Mar-2010

Relations

• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-43
First edition
2000-06
Medical electrical equipment –
Part 2-43:
Particular requirements for the safety
of X-ray equipment for interventional procedures
Appareils électromédicaux –
Partie 2-43:
Règles particulières de sécurité pour les appareils
radiologiques lors d'interventions

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-43
First edition
2000-06
Medical electrical equipment –
Part 2-43:
Particular requirements for the safety
of X-ray equipment for interventional procedures
Appareils électromédicaux –
Partie 2-43:
Règles particulières de sécurité pour les appareils
radiologiques lors d'interventions

 IEC 2000  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
W
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-43 © IEC:2000(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION .6

SECTION 1: GENERAL
Clause
1 Scope and object . 7
1.1 Scope . 7
1.2 Object.7
1.3 Particular standards . 8
2 Terminology and definitions . 8
6 Identification, marking and documents . 9
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts . 9
6.8.2 INSTRUCTIONS FOR USE . 10
6.8.3 Technical description. 12
6.8.101 Statement of compliance . 13
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 13
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 13
22 Moving parts.14
SECTION 5: PROTECTION AGAINST HAZARDS FROM

UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION. 15
29.201.2 HALF-VALUE LAYERS in X-RAY EQUIPMENT . 15
29.201.4 FILTRATION in X-RAY SOURCE ASSEMBLIES . 16
29.203.4 Correspondence between X-RAY FIELD and IMAGE RECEPTION AREA . 16
29.208.3 Designated SIGNIFICANT ZONES OF OCCUPANCY . 16
29.208.101 Isokerma maps . 16
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES

60601-2-43 © IEC:2000(E) – 3 –

SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES

AND OTHER SAFETY HAZARDS
42 Excessive temperatures. 17

44 Overflow, spillage, leakage, humidity, ingress of liquids,

cleaning, sterilization and disinfection . 18

44.1 General. 18

44.6 Ingress of fluids . 18

44.6.101 Footswitches . 18

SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output . 18
51.101 Control features . 19
51.102 Information to the OPERATOR. 20
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout . 22
59.101 Configuration for cardiopulmonary resuscitation (CPR) . 22
59.102 Attachment of protective drapes . 22
Annexes
L References - Publications mentioned in this standard. 23
AA Terminology – Index of defined terms. 24
BB Indications for the need to use EQUIPMENT complying with this standard. 26
CC The INTERVENTIONAL REFERENCE POINT. 28
DD Cleaning and disinfection . 29
EE Procedure for measuring REFERENCE AIR KERMA (RATE) . 30
FF Distribution maps of STRAY RADIATION. 33

Figures
101 Example of isokerma map at 100 cm height . 35
102 Example of isokerma map at 150 cm height . 36
Tables
101 Subclauses containing normative references to the ACCOMPANYING DOCUMENTS . 12
102 Addition to Table Xa in IEC 60601-1. 17
BB.1 Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for
which deterministic effects of IRRADIATION are possible. 26
BB.2 Examples of RADIOSCOPICALLY guided procedures for which deterministic effects
are unlikely. . 27

– 4 – 60601-2-43 © IEC:2000(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-43: Particular requirements for the safety of

X-ray equipment for interventional procedures

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-43 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this Particular Standard is based on the following documents:
FDIS Report of voting
62B/401/FDIS 62B/408/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.
Annexes AA, EE and FF form an integral part of this standard.
Annexes BB, CC and DD are for information only.
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested and definitions: roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: smaller type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2
OF THE GENERAL STANDARD, IN IEC 60788 OR IN THIS STANDARD: SMALL CAPITALS.

60601-2-43 © IEC:2000(E) – 5 –

This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.

The committee has decided that the contents of this publication will remain unchanged until

2005. At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or

• amended.
A bilingual version of this standard may be issued at a later date.

– 6 – 60601-2-43 © IEC:2000(E)

INTRODUCTION
In recent years, there have been major developments in the use of X-RAY EQUIPMENT for

RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. These procedures may involve

prolonged IRRADIATIONS and may subject PATIENTS and OPERATORS to higher levels of risk than

those which normally prevail.
A consequence is the occurrence of deterministic injury when procedures involve the delivery

of substantial amounts of RADIATION to localized areas on the PATIENT. Another consequence is

the large contribution to the stochastic risk for the RADIATION induced cancers etc. collectively

to the PATIENT.
This Particular Standard deals with these additional risks and thereby complements the
General Standard with special provisions for this particular domain. 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:2000(E) – 7 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-43: Particular requirements for the safety of

X-ray equipment for interventional procedures

SECTION 1: GENERAL
The clauses and subclauses of this section of
...