SIST EN 60601-2-46:2002

Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998)

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.

Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit von Operationstischen (IEC 60601-2-46:1998)

Appareils électromédicaux - Partie 2-46: Règles particulières de sécurité pour les tables d'opération (CEI 60601-2-46:1998)

Medicinska električna oprema - 2-46. del: Posebne varnostne zahteve za operacijske mize (IEC 60601-2-46:1998)

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2002
• Withdrawal Date: 06-Jan-2014
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 06-Jan-2014
• Due Date: 29-Jan-2014
• Completion Date: 07-Jan-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-46:1998 - Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables

Relations

• Replaced By: SIST EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 28-Jan-2023
• Revised: SIST EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 21-Jan-2014
• Replaced By: SIST EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 07-Jun-2022
• Revised: SIST EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 19-Jun-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-46:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
RSHUDFLMVNHPL]H,(&
Medical electrical equipment - Part 2-46: Particular requirements for the safety of
operating tables (IEC 60601-2-46:1998)
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
von Operationstischen (IEC 60601-2-46:1998)
Appareils électromédicaux - Partie 2-46: Règles particulières de sécurité pour les tables
d'opération (CEI 60601-2-46:1998)
Ta slovenski standard je istoveten z: EN 60601-2-46:1998
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 60601-2-46:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002
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

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SIST EN 60601-2-46:2002
– 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

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SIST EN 60601-2-46:2002
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

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SIST EN 60601-2-46:2002
– 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.

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SIST EN 60601-2-46:2002
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.

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SIST EN 60601-2-46:2002
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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.

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SIST EN 60601-2-46:2002
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 transfer of parts associated with an OPERATING TABLE.

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SIST EN 60601-2-46:2002
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4 General requirements for tests
This clause of the General Standard applies, except as follows:
Additional subclause:
4.6 Other conditions
aa) ACCESSORIES
OPERATING TABLES shall be fitted where they exist with at least the following ACCESSORIES:
a) anaesthetic screen;
b) arm rest.
*5 Classification
This clause of the General Standard applies.
6 Identification, marking and documents
This clause of the General Standard applies, except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
Addition:
aa) Concise instructions for use of the OPERATING TABLE in an emergency, for example failure
EQUIPMENT
of power supply, shall be provided on the outside of the or in a prominent
position in the operating room.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Addition:
aa) Instructions for use shall provide warnings referring to the manufacturers' instructions for
high-frequency surgical equipment, cardiac defibrillators and cardiac defibrillator-monitors.
6.8.3 Technical description
a) General
Addition:
For PERMANENTLY INSTALLED OPERATING TABLES, the technical description shall include the
following:
– information on the method of provision of an antistatic leakage path;
– if completion of this path depends upon installation on an antistatic floor, an instruction that
the resistances from the APPLIED PARTS of the table to protective earth have to be measured
after installation.

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