IEC 60601-2-46:1998

Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables

Specifies safety requirements for operating tables, whether or not having electrical parts, including transporters used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top.

General Information

• Status: Published
• Publication Date: 04-Jun-1998
• ICS: 11.140 - Hospital equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 16-Dec-2010

Relations

• Revised: IEC 60601-2-46:2010 - Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL
IEC
STANDARD
60601-2-46
First edition
1998-06
Medical electrical equipment –
Part 2-46:
Particular requirements for the safety
of operating tables
Appareils électromédicaux –
Partie 2-46:
Règles particulières de sécurité
pour les tables d’opération
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
60601-2-46
First edition
1998-06
Medical electrical equipment –
Part 2-46:
Particular requirements for the safety
of operating tables
Appareils électromédicaux –
Partie 2-46:
Règles particulières de sécurité
pour les tables d’opération
 IEC 1998  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
R
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-46 © IEC:1998(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION . 5

SECTION ONE – GENERAL
Clause
1 Scope and object . 6
2 Terminology and definitions . 7
4 General requirements for tests . 8
5 Classification . 8
6 Identification, marking and documents. 8
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 Separation . 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 10
20 Dielectric strength . 10
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 10
22 Moving parts . 11
24 Stability in NORMAL USE . 11
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-Radiation . 12
36 Electromagnetic compatibility . 12

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT . 13
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection. 13
49 Interruption of the power supply . 13

60601-2-46 © IEC:1998(E) – 3 –

Clause Page
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 14

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly . 14
Figures
101 Connection for potential equalization . 15
102 Test structure representing the SAFE WORKING LOAD. 16
Annexes
L References – Publications mentioned in this standard . 17
AA General guidance and rationale to clause 5 . 18

– 4 – 60601-2-46 © IEC:1998(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

_________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-46: Particular requirements for the safety of operating tables

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 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 60601-2-46 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and CENELEC.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/276/FDIS 62D/290/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex AA is for information only.
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
–
– test specifications: in italic type.
TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2
–
AND IN IEC 60601-1: SMALL CAPITALS.
A bilingual version of this standard may be issued at a later date.

60601-2-46 © IEC:1998(E) – 5 –

INTRODUCTION
This Particular Standard amends and supplements IEC 60601-1 (second edition, 1988):

Medical electrical equipment – Part 1: General requirements for safety, as amended by its

amendment 1 (1991) and its amendment 2 (1995), hereinafter referred to as the General

Standard (see 1.3).
This Particular Standard is necessary because of the special attention which has to be given to

features of OPERATING TABLES which are used together with OTHER MEDICAL ELECTRICAL

EQUIPMENT.
Additional requirements for safety, beyond those stated in the General Standard, are specified.
An asterisk (*) beside a clause or subclause number indicates that some explanatory notes are
given in annex AA at the end of this Particular Standard.

– 6 – 60601-2-46 © IEC:1998(E)

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-46: Particular requirements for the safety of operating tables

Section one – General
The clauses and subclauses of this section of the General Standard apply except as follows:

1 Scope and object
This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies safety requirements for OPERATING TABLES, as defined in
2.12.101, whether or not having electrical parts, including TRANSPORTERS, as defined in
2.12.104, used for the transportation of the table top to or from the base or pedestal of an
OPERATING TABLE with detachable table top.
This Particular Standard does not apply to
– dental patient chairs;
– examination chairs and couches;
– patient-supporting systems of diagnostic and therapeutic devices;
– operating table heating blankets;
– patient transfer equipment;
– delivery tables and beds;
– hospital beds;
– field tables.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety as amended by its amendments 1 (1991) and 2 (1995).

For brevity, part 1 is referred to in this Particular Standard either as the "General Standard" or
as the "General Requirements(s)".
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. 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 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.
60601-2-46 © IEC:1998(E) – 7 –

"Amendment" means that the clause or subclause of the General Standard is amended as

indicated by the text of this Particular Standard.

Subclauses or figures which are additional to those of the General Standard are numbered

starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

The term "this Standard" is used to make reference to the General Standard and this Particular

Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the

section, clause or subclause of the General Standard, although possibly not relevant, applies

without modification; where it is intended that any part of the General Standard, although possibly
relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
An asterisk (*) beside a clause or subclause number indicates that some explanatory notes are
given in the "General guidance and rationale" section at the end of this Particular Standard.
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
Additional definitions:
2.12.101
OPERATING TABLE (hereinafter also referred to as EQUIPMENT)
A PATIENT-supporting table for general, surgical/medical procedures
2.12.102
MOBILE OPERATING TABLE
An OPERATING TABLE intended to be moved from one location to another
2.12.103
NORMAL POSITION
The position of the OPERATING TABLE top with all sections set in the horizontal position
2.12.104
TRANSPORTER
A device intended for the transportation of the table top, with or without a PATIENT in place, to

or from the base or pedestal of an OPERATING TABLE, or the transportation of the table top
complete with the base, again with or without the PATIENT in place
NOTE – This does not include devices intended to simply transport the PATIENT from one location to another without
the tr
...