SIST EN 60601-2-46:2011

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

This particular standard 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 einschließlich der wesentlichen Leistungsmerkmale von Operationstischen

Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base et les performances essentielles des tables d'opération

La CEI 60601-2-46:2010 spécifie les exigences de sécurité applicables aux tables d'opération, que celles-ci comportent ou non des parties électriques, y compris les chariots de transfert, utilisés pour le transport du plateau vers ou depuis la base ou le socle d'une table d'opération à plateau mobile. Cette deuxième édition annule et remplace la première édition parue en 1998, et constitue une révision technique. La présente édition de la CEI 60601-2-46 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1.

Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz

Ta določeni standard opredeljuje varnostne zahteve za operacijske mize, ki imajo ali nimajo električnih delov, vključno s transporterji, ki se uporabljajo za prenos zgornje površine mize na bazo ali z nje ali podstavka operacijske mize z odstranljivo površino mize.

General Information

• Status: Withdrawn
• Publication Date: 14-Sep-2011
• Withdrawal Date: 14-Nov-2022
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 15-Nov-2022
• Due Date: 08-Dec-2022
• Completion Date: 15-Nov-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

Relations

• Replaced By: SIST EN IEC 60601-2-46:2020 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (IEC 60601-2-46:2016)
• Effective Date: 19-Nov-2019
• Revised: 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)
• Effective Date: 19-Jun-2009
• Replaces: 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)
• Effective Date: 28-Jan-2023
• Revised: 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)
• Effective Date: 21-Jan-2014
• Revised: SIST EN IEC 60601-2-46:2020 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (IEC 60601-2-46:2016)
• Effective Date: 11-Aug-2015
• Replaces: 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)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-46:2011
01-oktober-2011
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSHUDFLMVNLKPL]
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tables
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération
Ta slovenski standard je istoveten z: EN 60601-2-46:2011
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 60601-2-46:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-46:2011

---------------------- Page: 2 ----------------------

SIST EN 60601-2-46:2011

EUROPEAN STANDARD
EN 60601-2-46

NORME EUROPÉENNE
August 2011
EUROPÄISCHE NORM

ICS 11.140 Supersedes EN 60601-2-46:1998


English version


Medical electrical equipment -
Part 2-46: Particular requirements for the basic safety and essential
performance of operating tables
(IEC 60601-2-46:2010)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-46: Exigences particulières pour Teil 2-46: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des tables d'opération Leistungsmerkmale von
(CEI 60601-2-46:2010) Operationstischen
(IEC 60601-2-46:2010)





This European Standard was approved by CENELEC on 2011-01-20. 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


© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-46:2011 E

---------------------- Page: 3 ----------------------

SIST EN 60601-2-46:2011
EN 60601-2-46:2011 - 2 -
Foreword
The text of document 62D/870/FDIS, future edition 2 of IEC 60601-2-46, prepared by SC 62D,
Electromedical 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 60601-2-46 on 2011-01-20.
This European Standard supersedes EN 60601-2-46:1998.
EN 60601-2-46:1998 was revised to align structurally with EN 60601-1:2006.
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) 2012-02-20
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2014-01-20
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 smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD
OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.

---------------------- Page: 4 ----------------------

SIST EN 60601-2-46:2011
- 3 - EN 60601-2-46:2011
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 MDD (93/42/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-46:2010 was approved by CENELEC as a European
Standard without any modification.
__________

---------------------- Page: 5 ----------------------

SIST EN 60601-2-46:2011
EN 60601-2-46:2011 - 4 -
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

Replace IEC 60601-1-2 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests


Add:

IEC 60601-2-2 - Medical electrical equipment - EN 60601-2-2 -
Part 2-2: Particular requirements for basic
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories

---------------------- Page: 6 ----------------------

SIST EN 60601-2-46:2011
- 5 - EN 60601-2-46:2011
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 Directive concerned.

WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.

---------------------- Page: 7 ----------------------

SIST EN 60601-2-46:2011

---------------------- Page: 8 ----------------------

SIST EN 60601-2-46:2011
IEC 60601-2-46
®
Edition 2.0 2010-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-46: Particular requirements for the basic safety and essential performance
of operating tables

Appareils électromédicaux –
Partie 2-46: Exigences particulières pour la sécurité de base et les performances
essentielles des tables d'opération

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
R
CODE PRIX
ICS 11.140 ISBN 978-2-88912-290-5
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 9 ----------------------

SIST EN 60601-2-46:2011
– 2 – 60601-2-46 Ó IEC:2010
CONTENTS
FOREW ORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements. 9
201.5 General requirements for testing ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 10
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 10
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 Hazardous situations and fault conditions. 13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13
201.15 Construction of ME EQUIPMENT . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 16
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard . 19

Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 17

Table 201.101 – Determination of TENSILE SAFETY FACTOR . 12
Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application: . 18

---------------------- Page: 10 ----------------------

SIST EN 60601-2-46:2011
60601-2-46 Ó IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-46: Particular requirements for the basic safety
and essential performance of operating tables


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 recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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 60601-2-46 has been prepared by IEC subcommittee 62D
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 1998 and constitutes a
technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the
2005 edition of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/870/FDIS 62D/888/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.

---------------------- Page: 11 ----------------------

SIST EN 60601-2-46:2011
– 4 – 60601-2-46 Ó IEC:2010
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 smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

---------------------- Page: 12 ----------------------

SIST EN 60601-2-46:2011
60601-2-46 Ó IEC:2010 – 5 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of OPERATING
TABLES. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance),
hereinafter referred to as the general standard.
The aim of this third edition is to bring this particular standard up to date with reference to the
third edition of the general standard through reformatting and technical changes.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that knowledge of the reasons for these
requirements will not only facilitate the proper application of the standard but will, in due
course, expedite any revision necessitated by changes in clinical practice or as a result of
developments in technology. However, Annex AA does not form part of the requirements of
this Standard.

---------------------- Page: 13 ----------------------

SIST EN 60601-2-46:2011
– 6 – 60601-2-46 Ó IEC:2010
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-46: Particular requirements for the basic safety
and essential performance of operating tables



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This particular standard 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.
NOTE See also 4.2 of the General Standard.
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;
– medical beds;
– field tables.
NOTE If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant
requirements of each particular standard have to be considered.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for OPERATING TABLES as defined in 201.3.201 and hereinafter
also referred to as ME EQUIPMENT.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

---------------------- Page: 14 ----------------------

SIST EN 60601-2-46:2011
60601-2-46 Ó IEC:2010 – 7 –
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and
IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular ME
EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). 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 or applicable
collateral 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 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

---------------------- Page: 15 ----------------------

SIST EN 60601-2-46:2011
– 8 – 60601-2-46 Ó IEC:2010
201.2 Normative references
Clause 2 of the general standard applies, with the following exception:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-2-2, Medical electrical equipment – Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgical equipment and high frequency
surgical accessories
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
NOTE An index of defined terms is found beginning on page 19.
Addition:
201.3.201
MOBILE OPERATING TABLE
OPERATING TABLE intended to be relocated from one location to another while supported by its
own wheels or equivalent means
201.3.202
NORMAL POSITION
position of the OPERATING TABLE top with all sections set in the horizontal position
201.3.203
OPERATING TABLE (hereinafter also referred to as ME EQUIPMENT)
device for TEMPORARY USE, with the INTENDED USE of supporting and positioning a PATIENT
during surgical procedures
NOTE This includes pre- and post-operative phases in general, surgical/medical procedures under medical
supervision.
201.3.204
TEMPORARY USE
normally intended for continuous use for not more than 24 hours
201.3.205
TRANSPORTER
device intended for the transportation of an OPERATING TABLE top to or from the base or
pedestal of an OPERATING TABLE, or the transportation of the table top complete with the base
NOTE 1 This definition does not include devices intended to simplify the transport of the PATIENT from one
location to another without the transfer of parts associated with an OPERATING TABLE.
NOTE 2 The transportation can be done with or without a patient in place.

---------------------- Page: 16 ----------------------

SIST EN 60601-2-46:2011
60601-2-46 Ó IEC:2010 – 9 –
201.3.206
TRENDELENBURG POSITION
a supine PATIENT position where the body is in a single plane, with that plane inclined so that
the head is lower than the pelvis
201.4 General requirements
Clause 4 of the general standard applies except as follows.
201.4.3 Essential performance
Addition:
Besides the definition of the MANUFACTURER, the following ESSENTIAL PERFORMANCE is required
from OPERATING TABLES:
– no unwanted movement in any SINGLE FAULT CONDITION and any combined fault conditions
as derived from RISK MANAGEMENT specified by the MANUFACTURER.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
Additional SINGLE FAULT CONDITIONS to be regarded with OPERATING TABLES:
· flaw (impairment) in the transmission of commands from / to input devices.
NOTE 101 The MANUFACTURER should provide means, where practical, to ensure that in a SINGLE FAULT CONDITION
the PATIENT support platform of the OPERATING TABLE can return to a position for emergency treatment.
NOTE 102 Examples of positions for emergency treatment are TRENDELENBURG or positions for cardiopulmonary
resuscitation (CPR), emergency back flattening.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.10 Applied parts
Amendment:
The APPLIED PART marking symbol according to Table D.1 (symbol 19, 20 or 21) shall be
located in a prominent place. Compliance is checked by inspection.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Addition:

---------------------- Page: 17 ----------------------

SIST EN 60601-2-46:2011
– 10 – 60601-2-46 Ó IEC:2010
Instructions for use shall include information, regarding potential HAZARDS related to high-
frequency surgical equipment, cardiac defibrillators and cardiac defibrillator-monitors.
NOTE Potential HAZARDS which have to be considered include but are not limited to: PATIENT burns, explosion
...