IEC 60601-2-46:2010

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

IEC 60601-2-46:2010 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. 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.

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.

General Information

• Status: Published
• Publication Date: 15-Dec-2010
• ICS: 11.140 - Hospital equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 28 - TC 62/SC 62D/MT 28
• Current Stage: DELPUB - Deleted Publication
• Start Date: 10-Aug-2016
• Completion Date: 26-Oct-2025

Relations

• Revised: IEC 60601-2-46:2016 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-46:1998 - Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-46:2010 is an international standard published by the International Electrotechnical Commission (IEC) that establishes specific safety and performance requirements for operating tables used in medical environments. This standard applies to operating tables with or without electrical components, including transporters designed to move detachable table tops. Serving as a technical revision of the 1998 edition, IEC 60601-2-46:2010 aligns structurally with IEC 60601-1:2005, the general standard for basic safety and essential performance of medical electrical equipment.

The objective of IEC 60601-2-46:2010 is to ensure the basic safety and essential performance of operating tables, safeguarding patients and healthcare professionals during surgical procedures. It covers the mechanical, electrical, and functional aspects necessary for the reliable and safe operation of these critical medical devices.

Key Topics

• Scope and Applicability: The standard specifies requirements for operating tables commonly used in theaters, excluding dental patient chairs, examination tables, medical beds, and patient transfer equipment. It also addresses transporters related to detachable table tops.

• Safety Requirements: Focuses on protecting against electrical, mechanical, and radiation hazards. This includes safety from electrical shock, mechanical stability, prevention of excessive heat, and safe operation in the presence of flammable anesthetic mixtures.

• Essential Performance: Ensures that operating tables meet performance criteria vital for surgical settings, including weight distribution safety, accurate control mechanisms, stability during patient positioning, and durability under load.

• Testing and Compliance: Details the classification, identification, marking, and documentation requirements, including mandatory testing methods to verify conformity with safety standards.

• Electromagnetic Compatibility (EMC): Defines how operating tables must maintain performance without causing or being affected by electromagnetic interference, consistent with IEC 60601-1-2 requirements as modified in this standard.

• Programmable Electrical Medical Systems (PEMS): Provides guidance for operating tables integrated with programmable electronics, ensuring software reliability and hazard prevention.

Applications

IEC 60601-2-46:2010 is essential for manufacturers, regulators, and healthcare providers involved in the design, production, approval, and use of operating tables in medical facilities. Key practical applications include:

• Design and Manufacturing: Incorporating standardized safety and performance requirements during the development of operating tables to ensure compliance with international regulations.

• Risk Management: Identifying and mitigating electrical, mechanical, and thermal hazards associated with operating tables to reduce risks during surgical procedures.

• Regulatory Approval: Facilitates certification processes by setting internationally recognized benchmarks for safety and essential performance, aiding manufacturers in achieving market authorization.

• Clinical Safety: Enhances patient and operator safety by standardizing stability and control features, ensuring reliable and consistent table performance under diverse clinical conditions.

• Compatibility Assurance: Ensures that operating tables function effectively alongside other medical electrical equipment without interference, vital in complex surgical environments.

Related Standards

IEC 60601-2-46:2010 is part of the broader IEC 60601 series that addresses medical electrical equipment and systems. Related standards include:

• IEC 60601-1:2005 – General requirements for basic safety and essential performance of medical electrical equipment; forms the foundational framework for IEC 60601-2-46.

• IEC 60601-1-2 – Requirements for electromagnetic compatibility of medical electrical equipment; partially modified for application in IEC 60601-2-46.

• Other Collateral Standards in the IEC 60601 Series – Cover various aspects such as electrical safety, alarm systems, usability, and software lifecycle processes, which also impact the design and testing of operating tables.

Further details including normative references, definitions, and testing methodologies can be accessed through the official IEC publications and the IEC webstore.

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By adhering to IEC 60601-2-46:2010, stakeholders ensure operating tables meet critical safety benchmarks and perform reliably, enhancing the efficacy and safety of surgical interventions internationally. This standard contributes significantly to harmonizing medical device safety, improving patient outcomes, and supporting innovation in medical equipment design.

Standards Content (Sample)

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

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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
– 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

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
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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.

– 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.
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.
– 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.

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.

– 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.

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:
– 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:

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 fact that it is not always possible to determine in general whether a specific
component or construction is impaired by wear, the decision shall be based on experience ,
tests and/or RISK MANAGEMENT and shall be documented accordingly. However, the
MANUFACTURER is responsible for choosing the adequate TENSILE SAFETY FACTOR.
The OPERATING TABLE or TRANSPORTER shall be tested:
– with the SAFE WORKING LOAD (required PATIENT weight according to Figure AA.1 and
Table AA.1) and a TENSILE SAFETY FACTOR according to Table 201.101:

– 12 – 60601-2-46 Ó IEC:2010
Table 201.101 – Determination of TENSILE SAFETY FACTOR
Situation Minimum
TENSILE
SAFETY
FACTOR
No. System Part Elongation
1 Support system not impaired Material having a specific 2,5
by wear elongation at break equal to or
greater than 5 %
2 Support system not impaired Material having a specific 4
by wear elongation at break of less than
5 %
3 Support system impaired by Material having a specific 5
wear elongation at break equal to or
greater than 5 %
4 Support system impaired by Material having a specific 8
wear
elongation at break of less than
5 %
The material tensile strength and all external forces to be expected are quantifiable
and known accurately.
Compliance with 201.9.8.1 and 201.9.8.2 is checked by inspection of the OPERATING TABLE or
TRANSPORTER , the RISK MANAGEMENT FILE, the specifications of materials used and the
processing specifications for these materials.
When test results are part of relevant information, testing consists of gradually applying a test
load to the support assembly under test equal to the SAFE WORKING LOAD times the required
TENSILE SAFETY FACTOR. The support assembly under test is to be in equilibrium after 1 min, or
otherwise not result in an unacceptable RISK.
NOTE The 1 min time period might need to be longer for materials which might have creep type problems, such
as plastics or other non-metallic materials.
201.9.8.3.2 *Static forces due to loading from persons
Replacement of item b):
b) OPERATING TABLES and TRANSPORTERS shall be designed so that failure or permanent
deformation shall not occur when subjected to 2,2 times SAFE WORKING LOAD.
NOTE See Figure AA.1 and Table AA.1 for guidance regarding weight distribution.
Compliance is checked by the following test:
1) In NORMAL POSITION and at maximum height the ME EQUIPMENT shall be statically loaded
with 2,2 times SAFE WORKING LOAD. The deformation after 5 min is recorded. The
ME EQUIPMENT shall not be operated or moved during this part of the test.
2) The load is removed and replaced as soon as practical with SAFE WORKING LOAD.
3) After waiting 5 min. in NORMAL POSITION and at maximum height the ME EQUIPMENT shall
be statically loaded with 2,2 times SAFE WORKING LOAD. The deformation after 5 min. is
recorded.
The deflections are compared to the values measured under a) and shall be within
± 2,5 mm of the original readings.
4) The load is removed and replaced with SAFE WORKING LOAD and the ME EQUIPMENT shall
operate over the full range of movements. The deformation/deflection shall be
measured at the end of the head- and leg-section of the operating table. For
accessories the measuring point shall be determined according the intended use.

60601-2-46 Ó IEC:2010 – 13 –
201.9.8.3.3 *Dynamic forces due to loading from persons
This subclause of the general standard does not apply.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT
Additional subclause:
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
OPERATING TABLES shall be at least IPX4.
201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT
Addition:
In the event of interruption of the SUPPLY MAINS, whether or not the SUPPLY MAINS is restored,
the height and configuration of the table top shall not alter. Movement into NORMAL POSITION
and/or TRENDELENBURG POSITION shall remain possible.
Compliance is checked as follows:
a) By test after interruption of the SUPPLY MAINS with the table top in any position, other than
the NORMAL POSITION, midway between its maximum and minimum heights, subjected to
SAFE WORKING LOAD with weight distributed according to Figure AA.1 and Table AA.1.
Movement into and out of the NORMAL POSITION shall be obtainable using the methods
described by the MANUFACTURER.
b) By observation after restoration of the SUPPLY MAINS.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard applies.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.

– 14 – 60601-2-46 Ó IEC:2010
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except of follows:
201.15.3.5 Rough handling test
Amendment:
Subclause 15.3.5 of the General Standard applies to TRANSPORTERS and MOBILE OPERATING
TABLES only.
201.15.4.7.2 Accidental operation of ME EQUIPMENT
Addition:
201.15.4.7.2.101 Inadvertent operation
The actuating force for foot-operated control devices shall not be smaller than 10 N.
Compliance is checked by inspection.
201.16 ME SYSTEMS
Clause 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies.
202 Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2:2007 applies, except as follows:
202.6.2.2.1 Requirements
Replacement:
ME EQUIPMENT shall comply with the requirements of 6.2.1.10 [of IEC 60601-1-2:2007] as
modified below. For this requirement, the following conditions associated with BASIC SAFETY
and ESSENTIAL PERFORMANCE shall apply:
No permanent DEGRADATION or loss of function or OPERATOR settings which are not
recoverable shall be observed at any immunity test level.
No inappropriate movement shall occur at all immunity test levels.
At all immunity test levels the ME EQUIPMENT shall maintain ESSENTIAL PERFORMANCE within the
specification limits.
At all immunity test levels the temporary DEGRADATION or loss of function or performance is
acceptable.
Within 10 s or after OPERATOR intervention without requiring the use of a tool, the
ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of

60601-2-46 Ó IEC:2010 – 15 –
any OPERATOR settings or stored data, and shall continue to perform its intended function as
described in the ACCOMPANYING DOCUMENTS.
Check compliance by application of the tests in 6.2.2.2. Evaluate the response of the
ME EQUIPMENT or ME SYSTEM during and after these tests in accordance with 6.2.1.10 [of
IEC 60601-1-2:2007] as modified in above, considering each discharge individually.
Additional subclause:
202.6.2.2.1.101 Interference with high-frequency surgical equipment
OPERATING TABLES and remote control devices for OPERATING TABLES shall not present a
HAZARDOUS SITUATION when used together with high-frequency surgical equipment.
Compliance is checked by the following tests:
NOTE 1 To accommodate the huge variety of high-frequency surgical equipment, two different test-scenarios
have been created.
a) The high-frequency surgical equipment which is used for this test shall comply with
IEC 60601-2-2, shall have a rated output power of 300 W at least for an impedance
between 200 Ohms and 500 Ohms, a quasi-square wave output frequency characteristic
and shall operate in the frequency range of 400 kHz to 1 MHz.
b) The high frequency surgical equipment which is used for this test shall comply with
IEC 60601-2-2, shall have an argon plasma coagulation mode with a peak voltage of
4 000 Vp (open circuit voltage) and 120 W power capability
NOTE 2 For details, see Annex A.
In all cases shall leads of the active and neutral electrodes be draped along the side rails
and/or the exposed metal parts of the OPERATING TABLE top.
The high frequency surgical equipment shall then be operated in a mode which generates
an output power of 300 W ("conventional") or 4 000 Vp/120 W (argon plasma coagulation).
c) Compliance
1) Operating the high frequency surgical equipment at open circuit shall cause no
movement of the OPERATING TABLE.
2) Operating the high-frequency surgical equipment while short-circuiting the active and
neutral electrodes and sparking with the active electrodes at the side rails and/or the
exposed metal parts of the OPERATING TABLE top, shall cause no movement of the
OPERATING TABLE.
NOTE 3 If operating tables will be used in combination with diagnostic X-ray equipment, the relevant
requirements of the collateral standard have to be considered.

– 16 – 60601-2-46 Ó IEC:2010
Annexes
The annexes of the general standard apply, except as follows:

Annex G
(normative)
Protection against hazards of ignition of flammable anaesthetic mixtures

Annex G of the general standard applies, except as follows:
201.G.4.3 Prevention of electrostatic charges
Addition:
Provision of electrically conductive paths from MOBILE OPERATING TABLES to a conductive floor
or the protective earth system or the potential equalization system or via wheels to an
antistatic floor of the medically used room shall exist, whether or not the table is connected to
a SUPPLY MAINS.
The electrical resistance limits of mattresses and pads for castor tyres OPERATING TABLES and
4 7
other antistatic material shall be at a minimum 10 W and at a maximum 10 W.
Compliance is checked by measurement of the electrical resistance according ISO 2878.
NOTE The electrical resistance responsible for the prevention of electrostatic charges does not prevent burns
caused by the use of high-frequency surgical ME EQUIPMENT and is no protection against electric shock hazards.

60601-2-46 Ó IEC:2010 – 17 –
Annex AA
(informative)
Particular guidance and rationale

The following are rationales for specific clauses and subclause in this particular standard, with
clause and subclause numbers parallel to those in the body of the document.
Subclause 201.9.2.3.1 – Unintended movement
The requirement has been added in order to avoid unintended operation because of mixing up
of remote controls in the department.
Subclause 201.9.4.2.2 – Instability excluding transport
Human bodies do not gain mass at the same rate in all body parts, thus Figure A.19 of the
general standard is not representative for morbidly obese patients. Figure AA.1, in
combination with Table AA.1, is recommended for use for higher mass PATIENTS. Figure AA.1
represents a 135 kg “baseline” PATIENT mass. For SAFE WORKING LOADS greater than 135 kg,
the additional mass should be added to each body part in the proportions given in Table AA.1.
Figure AA.1 contains an example of human body mass distribution for a 135 kg PATIENT and
body part labels for use in conjunction with Table AA.1.
Dimensions in millimetres
Hand
Arm
Upper leg
Lower leg
Lower body Upper body Head
27,5 kg 27,5 kg 10 kg
10 kg
15 kg
5 kg
5 kg
180 500
450 550 350 350 180
1 900
135 kg
IEC  2858/10
Figure AA.1 – Recommended distribution of mass in excess of 135 kg
and examples of application
– 18 – 60601-2-46 Ó IEC:2010
Table AA.1 – Recommended distribution of mass in excess of 135 kg
and examples of application
Lower Leg Upper Leg Lower Upper Hand Upper Arm Head
Body Body
Percentage of added 10 % total 32 % total 32 % 14 % 3,0 % 7 % total 2,0 %
(5 % each)
mass (over 135 kg) to (16 % total (3,5 %
be applied to each part each) (1,5 % each)
each)
Examples of application of additional mass for PATIENTS over 135 kg
135 kg PATIENT 10 kg each 15 kg each 27.5 kg 27.5 kg 5 kg each 5 kg each 10 kg
(reference)
250 kg PATIENT 15.8 kg 33.4 kg 64,3 kg 43,6 kg 6,7 kg 9 kg each 12,3 kg
each each each
360 kg PATIENT 21.3 kg 51 kg each 99,5 kg 59 kg 8,.4 kg 12,9 kg 14,5 kg
each each each
Subclause 201.9.4.2.4.3 – Movement over a threshold
Occurrence of such threshold is not likely to occur in the operating theatre environment.
Subclause 201.9.8.2 – TENSILE SAFETY FACTOR
Support systems are not necessarily made of metallic materials. Therefore the considerations
according the TENSILE SAFETY FACTOR shall be referenced to the term “material” only.
For example, PATIENT tables of X-ray/CT/MR systems are often designed with plastic materials
laminated or reinforced by carbon fibres/cloths or glass fibres/cloths, since these PATIENT
tables must be optimised for low absorption of X-ray radiation (aluminium equivalence), MR
compatibility (low proton signal), as well as structural stability. Although these plastic
materials reinforced by carbon fibres/cloths can have elongation at break of less than 5 %,
many years knowledge, acquired expertise, and post-market surveillance can provide
sufficient evidence that suitable structural stability of PATIENT tables is achieved by applying a
TENSILE SAFETY FACTOR from Table 201.101, Situation 1 (rather than Situation 2).
Further, it is not always possible to determine in general whether a specific component or
construction is impaired by wear.
Therefore the choice of the applicable TENSILE SAFETY FACTOR may be based on experience ,
tests and/or risk management and has to be documented accordingly.
Subclause 201.9.8.3.2 – Static forces due to loading from persons
The TENSILE SAFETY FACTOR requirements in 201.9.8.2 are still applicable. They are not
overridden by the performance requirements in 201.9.8.3.2.
Subclause 201.9.8.3.3 – Dynamic forces due to loading from persons
The loading of the patient onto the OPERATING TABLE is performed in a controlled environment
by professionals familiar with proper technique.

60601-2-46 Ó IEC:2010 – 19 –
Index of defined terms used in this particular standard
ACCESSIBLE PART . IEC 60601-1:2005, 3.2
ACCESSORY . IEC 60601-1:2005, 3.3
APPLIED PART .
...