IEC 60601-2-46:2010

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

IEC 60601-2-46:2010

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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

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– 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

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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,
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agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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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 60601-2-46 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.

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– 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.

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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.

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– 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.

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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.

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– 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.

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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:

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– 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
HAZARDS or electrical shock of the PATIENT or OPERATOR.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.6.7 Potential equalization conductor
Addition:
Where potential equalization is required, the APPLIED PARTS of OPERATING TABLES with
ACCESSIBLE PARTS which are not PROTECTIVELY EARTHED shall be provided with a potential
equalization terminal.
For ME EQUIPMENT with potential equalization terminal the impedance between the potential
equalization terminal and any ACCESSIBLE PART shall not exceed 200 mW,
Compliance is checked by using the test method of 8.6.4 of the general standard.
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2.3 Other HAZARDS associated with moving parts
201.9.2.3.1 *Unintended movement
Addition:
Wireless remote control devices of OPERATING TABLES shall be clearly assigned by internal
means to the individual items of ME EQUIPMENT.
Compliance is checked by inspection.
201.9.4.2.2 *Instability excluding transport
Item a)
Addition:
ME EQUIPMENT shall be subjected to SAFE WORKING LOAD.
NOTE See Figure AA.1 and Table AA.1 for guidance regarding weight distribution.
Additional requirement:
OPERATING TABLES with transferable table tops shall be designed and manufactured so as to
minimize the RISK of physical injuries and of accidental separation of the table tops when
being transferred.
Specifications concerning table-top transfer operations shall indicate in the instructions for
use the safety elements inherent in the transfer operation.
Compliance is checked by inspection and the following tests:

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60601-2-46 Ó IEC:2010 – 11 –
Having transferred the table top to the TRANSPORTER, the stability in NORMAL USE test of
9.4.2.2 shall be carried out. The table top shall not disengage from the TRANSPORTER.
The test is then repeated with the table top being placed on the base and the stability test is
carried out on the base immediately after transfer.
201.9.4.2.4.3 *Movement over a threshold
Addition:
If MOBILE OPERATING TABLES and TRANSPORTERS are not able to negotiate such obstacles
safely, the manufacturer shall include a warning in the instructions for use or determine which
threshold can be negotiated safely and inform the operator accordingly.
201.9.4.3.1 Instability in transport
Replacement of items b) and c)of the test procedure:
The MOBILE OPERATING TABLE or TRANSPORTER is placed with the SAFE WORKING LOAD in place,
and the locking device (e.g. brakes) activated, on a plane covered with 2 mm to 4 mm thick
vinyl flooring material and inclined at 6° from the horizontal plane on a concrete floor.
Following initial elastic movement, initial creepage, and initial pivoting of castors, there shall
be no movement of the MOBILE OPERATING TABLE or TRANSPORTER greater than 50 mm (in
relation to the inclined plane). Any initial movement shall not result in an unacceptable RISK,
taking into account the NORMAL USE of the MOBILE OPERATING TABLE or TRANSPORTER.
NOTE See Figure AA.1 and Table AA.1 for guidance regarding weight distribution.
201.9.8.1 General
Replacement of first dash:
– The construction of the support, suspension or actuation system shall be designed based
upon Table 201.21 and the SAFE WORKING LOAD.
201.9.8.2 *TENSILE SAFETY FACTOR
Replacement:
Support systems shall maintain structural integrity during the EXPECTED SERVICE LIFE of the
OPERATING TABLE or TRANSPORTER. TENSILE SAFETY FACTORS shall not be less than those shown
in Table 201.21 unless an alternative method demonstrates structural integrity throughout the
EXPECTED SERVICE LIFE of the OPERATING TABLE or TRANSPORTER.
Due to the
...