IEC 60601-2-46:2023

IEC 60601-2-46 ®
Edition 4.0 2023-05
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-46: Particular requirements for the basic safety and essential performance
of operating tables
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IEC 60601-2-46 ®
Edition 4.0 2023-05
COMMENTED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-46: Particular requirements for the basic safety and essential performance
of operating tables
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.140 ISBN 978-2-8322-7087-5
– 2 – IEC 60601-2-46:2023 CMV © IEC 2023
CONTENTS 1
FOREWORD .4
INTRODUCTION .7

201.1 Scope, object and related standards .8
201.2 Normative references. 10
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing OPERATING TABLES ME EQUIPMENT. 12
201.6 Classification of OPERATING TABLES ME EQUIPMENT and ME SYSTEMS . 12
201.7 OPERATING TABLES ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from OPERATING TABLES ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES ME EQUIPMENT and
ME SYSTEMS . 13
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions for OPERATING TABLES ME EQUIPMENT . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201.15 Construction of OPERATING TABLES ME EQUIPMENT . 17
201.16 ME SYSTEMS . 17
201.17 Electromagnetic compatibility of OPERATING TABLES ME EQUIPMENT and ME
SYSTEMS . 17
202 Electromagnetic disturbances – Requirements and tests . 17
203 *Radiation protection in diagnostic X-ray equipment . 21

Annexes . 22
Annex G (normative) Protection against hazards of ignition of flammable anaesthetic
mixtures . 23
Annex AA (informative) Particular guidance and rationale . 24
Bibliography . 28
Index of defined terms used in this particular standard . 29
List of comments . 30

Figure 202.101 – ENCLOSURE ad hoc test . 19
Figure 202.102 – POWER SUPPLY CORD ad hoc test. 20
Figure 202.103 – ACCESSORY cable ad hoc test . 20
Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 24
Figure AA.2 – Typical stress-strain curve . 26
Figure AA.3 – Typical bending line along the length L of a beam . 26
Table 201.101 – Determination of TENSILE SAFETY FACTOR . 15
Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 25

– 4 – IEC 60601-2-46:2023 CMV © IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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This commented version (CMV) of the official standard IEC 60601-2-46:2023 edition 4.0
allows the user to identify the changes made to the previous IEC 60601-2-46:2016
edition 3.0. Furthermore, comments from IEC SC 62D experts are provided to explain the
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This publication contains the CMV and the official standard. The full list of comments is
available at the end of the CMV.

IEC 60601-2-46 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This fourth edition cancels and replaces the third edition published in 2016. This edition
constitutes a technical revision 2.
This edition includes the following significant technical change with respect to the previous
edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/1939/CDV 62D/1989/RVC
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the 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 document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, 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 document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– 6 – IEC 60601-2-46:2023 CMV © IEC 2023
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "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 document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.

INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of OPERATING
TABLES.
It amends and supplements IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020.
The aim of this document is to update it with reference to IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 through reformatting and technical
changes.
The requirements of this particular standard take priority over those of IEC 60601-1:2005, IEC
60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
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 document.

– 8 – IEC 60601-2-46:2023 CMV © IEC 2023
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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause
1, applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 specifies safety requirements for OPERATING TABLES, whether or not
having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING
TABLE top to or from the base or pedestal of an OPERATING TABLE with detachable OPERATING
TABLE top.
NOTE See also IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 4.2.
This particular standard does not apply to 3
– dental PATIENT chairs (see ISO 7494-1),
– examination chairs and couches,
– PATIENT-supporting systems of diagnostic, interventional and therapeutic devices equipment
(see IEC 60601-2-54 or IEC 60601-2-43),
– OPERATING TABLE heating blankets (see IEC 80601-2-35 IEC 60601-2-35),
– PATIENT transfer equipment,
– delivery tables and delivery beds,
– medical beds (see IEC 60601-2-52 and EN 50637), and
– field tables.
If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the
relevant requirements of each related particular standard are also applicable.
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 201.3.201203.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 2, and Clause 201.2 of this particular standard.

IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.
IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 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 IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of IEC 60601-1:2005, IEC
60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause 1) 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 IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content
of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 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 IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from 201.101.
However, due to the fact that definitions in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through 3.147154, additional definitions
in this document 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 document" is used to make reference to IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral standards and
this particular standard taken together.

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Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/
AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this particular
standard.
201.2 Normative references 4
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 2, applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
ray equipment
Amendment 1:2013
Amendment 2:2021
ISO 2878:2017, Rubber, vulcanized or thermoplastic – Antistatic and conductive products –
Determination of electrical resistance
Addition:
IEC 60601-2-2:2017, 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
IEC 60601-2-43:2022, Medical electrical equipment – Part 2-43: Particular requirements for the
basic safety and essential performance of X-ray equipment for interventional procedures
IEC 60601-2-54:2022, Medical electrical equipment – Part 2-54: Particular requirements for the
basic safety and essential performance of X-ray equipment for radiography and radioscopy
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following apply,
except as follows:.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE An index of defined terms is found on page 29.
______________
There exists a consolidated edition 2.1, which includes IEC 60601-1-3:2008 and its Amendment 1 (2013).

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
device with the INTENDED USE of supporting and positioning a PATIENT during surgical procedures
for not more than 24 h
Note 1 to entry: This includes pre- and post-operative phases in general, surgical/medical procedures under
medical supervision.
Note 2 to entry: The device may serve as a PATIENT-supporting systems during diagnostic, interventional and
therapeutic procedures but still considered to be a separate ME EQUIPMENT. 5
201.3.204
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 OPERATING TABLE top complete with the base
Note 1 to entry: 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 to entry: The transportation can be done with or without a PATIENT in place.
201.3.205
TRENDELENBURG POSITION
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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 4, applies, except as follows.
201.4.3 Essential performance
Addition:
Besides the definition of the MANUFACTURER, the following shall be considered ESSENTIAL
PERFORMANCE is required from for OPERATING TABLES: supporting a PATIENT without unwanted
unintended movement (motorized or not) leading to an unacceptable risk 6 in a SINGLE FAULT
CONDITION.
201.4.7 SINGLE FAULT CONDITION for OPERATING TABLES ME EQUIPMENT
Addition:
Additional SINGLE FAULT CONDITIONS to be regarded with OPERATING TABLES:
• flaw (impairment) in the transmission of commands from/to input devices.

– 12 – IEC 60601-2-46:2023 CMV © IEC 2023
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 101 Examples of positions for emergency treatment are TRENDELENBURG or positions for cardiopulmonary
resuscitation (CPR), emergency back flattening.
201.5 General requirements for testing OPERATING TABLES ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 5, applies.
201.6 Classification of OPERATING TABLES ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 6, applies.
201.7 OPERATING TABLES ME EQUIPMENT identification, marking and documents
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 7, applies, except as follows:
201.7.2 Marking on the outside of OPERATING TABLES ME EQUIPMENT or OPERATING TABLES
ME EQUIPMENT parts
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. 7
201.7.2.21 Mass of MOBILE OPERATING TABLES ME EQUIPMENT
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 7.2.21, does not apply.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Addition:
Instructions for use shall include information regarding potential HAZARDS related to HIGH
FREQUENCY SURGICAL EQUIPMENT 8, cardiac defibrillators and cardiac defibrillator-monitors.
NOTE 101 Potential HAZARDS which have need 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 OPERATING TABLES ME
EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 8, 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 or a potential equalization connector. 9
For OPERATING TABLES with a POTENTIAL EQUALIZATION terminal, the impedance between the
potential equalization terminal or connector and any ACCESSIBLE PART shall not exceed 200 mΩ.
Compliance is checked by using the test method of IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 8.6.4.
201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES ME
EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 9, applies, except as follows:
201.9.2.3 Other MECHANICAL 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 OPERATING TABLES.
Compliance is checked by inspection.
201.9.4 Instability HAZARDS
201.9.4.2.2 *Instability excluding transport position
Item a)
Addition:
OPERATING TABLES shall be subjected to SAFE WORKING LOAD.
NOTE See Figure AA.1 and Table AA.1 for guidance regarding mass distribution.
Additional requirement:
OPERATING TABLES with transferable OPERATING TABLE tops shall be designed and manufactured
so as to minimize the RISK of physical injuries and of accidental separation of the OPERATING
TABLE tops when being transferred.
Specifications concerning OPERATING 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.
Having transferred the OPERATING TABLE top to the TRANSPORTER, the stability in NORMAL USE
test of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 9.4.2.2, shall be carried out. The
OPERATING TABLE top shall not disengage from the TRANSPORTER.

– 14 – IEC 60601-2-46:2023 CMV © IEC 2023
The test is then repeated with the OPERATING 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 position
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 mass distribution.
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.1 General
Replacement of first dash:
– The construction of the support, suspension or actuation system shall be designed based
upon Table 201.101 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 201.101 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 mass according to Figure AA.1 and Table AA.1) and a TENSILE SAFETY FACTOR according
to Table 201.101.
Table 201.101 – Determination of TENSILE SAFETY FACTOR
Situation Minimum
TENSILE SAFETY
FACTOR
No. System part Elongation
1 Support system not impaired by wear Material having a specific elongation at 2,5
break equal to or greater than 5 %

2 Support system not impaired by wear Material having a specific elongation at 4
break of less than 5 %
3 Support system impaired by wear Material having a specific elongation at 5
break equal to or greater than 5 %

4 Support system impaired by wear Material having a specific elongation at 8
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 shall 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 in NORMAL
POSITION. 10
NOTE 101 See Figure AA.1 and Table AA.1 for guidance regarding mass distribution.
Compliance is checked by the following test.
1) In NORMAL POSITION and at maximum height, the OPERATING TABLES shall be statically
loaded with 2,2 times SAFE WORKING LOAD. The deformation after 5 min is recorded. The
OPERATING TABLES 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 OPERATING TABLES
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 1) and shall be within
±2,5 mm of the original readings.
4) The load is removed and replaced with SAFE WORKING LOAD and the OPERATING TABLES
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.
201.9.8.3.3 *Dynamic forces due to loading from persons
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 9.8.3.3,
does not apply.
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201.10 Protection against unwanted and excessive radiation HAZARDS
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause
10, applies.
NOTE The collateral standard IEC 60601-1-3 is referenced in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 and is covered under Clause 203 of this document. 11
201.11 Protection against excessive temperatures and other HAZARDS
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 11, 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
OPERATING TABLES ME EQUIPMENT
201.11.6.5 Ingress of water or particulate matter into OPERATING TABLES ME EQUIPMENT
and ME SYSTEMS
Addition:
OPERATING TABLES shall be at least IPX4.
201.11.8 Interruption of the power supply/SUPPLY MAINS to OPERATING TABLES 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 OPERATING 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 OPERATING TABLE top in any position,
other than the NORMAL POSITION, midway between its maximum and minimum heights,
subjected to SAFE WORKING LOAD with mass 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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 12, applies.
201.13 HAZARDOUS SITUATIONS and fault conditions for OPERATING TABLES ME
EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 13, applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 14, applies.
201.15 Construction of OPERATING TABLES ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 15, 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. 12
201.15.4 ME EQUIPMENT components and general assembly
Additional subclause:
201.15.4.101 *Pads for OPERATING TABLES 13
The MANUFACTURER shall provide evidence of durability and pressure distribution and
demonstrate that the pads are designed to their intended purpose. The methodology used shall
be based on experience and/or RISK MANAGEMENT and shall be documented accordingly.
Compliance is checked by inspection of documentation.
201.15.4.7.2 Accidental operation of OPERATING TABLES ME EQUIPMENT
Additional subclause:
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
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause
16, applies.
201.17 Electromagnetic compatibility of OPERATING TABLES ME EQUIPMENT and
ME SYSTEMS
IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020, Clause 17, applies.
202 Electromagnetic disturbances – Requirements and tests
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 applies, except as follows:

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202.8 Electromagnetic IMMUNITY requirements for OPERATING TABLES ME EQUIPMENT and
ME SYSTEMS
Additional subclauses:
202.8.101 IMMUNITY pass/fail criteria
At least the following IMMUNITY pass/fail criteria associated with BASIC SAFETY and ESSENTIAL
PERFORMANCE shall apply at all immunity test levels:
– no permanent degradation or loss of function or OPERATOR settings which are not
recoverable shall be observed;
– no movement without activation of the OPERATOR shall occur;
– no movement, other than intended by the OPERATOR, shall occur;
– the OPERATING TABLE shall maintain ESSENTIAL PERFORMANCE within the limits specified by
the MANUFACTURER (e.g. temporary degradation of functionality);
– within 15 s after the immunity test, the OPERATING TABLE shall resume normal operation in
the previous operating mode, without loss of any OPERATOR settings or stored data, and
shall continue to perform its intended function as described in the ACCOMPANYING
DOCUMENTS.
202.8.102 IMMUNITY to HF SURGICAL EQUIPMENT EMISSIONS
Electrical OPERATING TABLES intended for use within 2 m of active HF SURGICAL EQUIPMENT or to
have a connection to a PATIENT undergoing treatment with HF SURGICAL EQUIPMENT shall be
tested for IMMUNITY to HF SURGICAL EQUIPMENT EMISSIONS.
The IMMUNITY pass/fail criteria of 202.8.101 shall apply.
All tests have to shall be performed in two conditions:
– without activating a movement of the OPERATING TABLE;
– with activating any movement of the OPERATING TABLE (e.g. height movement).
In order to accommodate the huge variety of HF SURGICAL EQUIPMENT, all the tests described in
202.8.102 have to shall be applied with two different HF SURGICAL EQUIPMENT:
– HF SURGICAL EQUIPMENT complying with IEC 60601-2-2 and having a minimum power cut
mode capability of 300 W, a minimum coagulation mode of 100 W and working frequencies
to include at least 400 kHz ± 100 kHz; the HF SURGICAL EQUIPMENT used shall be specified
in the test report;
– HF SURGICAL EQUIPMENT, should have with an argon plasma coagulation mode with a
minimum 14 peak-to-peak voltage of 4 000 Vp (open circuit voltage) and 120 W power
capability; the HF SURGICAL EQUIPMENT used shall be specified in the test report.
NOTE 1 The EM environment for OPERATING TABLES is a special environment (medical treatment areas with high-
powered OPERATING TABLES). Besides the immunity tests required for the professional healthcare facility environment
(according to IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, Table 4 to Table 9), at least immunity to HF
emissions as described in 202.8.102 is applicable to OPERATING TABLES.
SURGICAL EQUIPMENT
Compliance is checked by the following tests.
a) For parts of OPERATING TABLES that are not PATIENT-COUPLED (e.g. remote control devices,
foot-switches), wrap the cable of a MONOPOLAR HF SURGICAL ACCESSORY around the
ENCLOSURE of such parts so that at least two full loops of the cable are present, as shown
in Figure 202.101. No more than three loops are needed. If the part of the OPERATING TABLE
is too large to accommodate two loops, wrap as much as possible or drape the cable over
the portion of the parts of the OPERATING TABLE that is most likely to come in contact with HF
SURGICAL EQUIPMENT ACCESSORY cables.
Attach one end of a cable to the NEUTRAL ELECTRODE connector of the HF SURGICAL
EQUIPMENT and the other end to a metal plate. Using the MONOPOLAR HF SURGICAL
ACCESSORY, acti
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