SIST EN IEC 60601-2-46:2024

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz (IEC 60601-2-46:2023)
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tables (IEC 60601-2-46:2023)
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationstischen (IEC 60601-2
-46:2023)
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération (IEC 60601-2-46:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-46:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-46

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.140 Supersedes EN IEC 60601-2-46:2019
English Version
Medical electrical equipment - Part 2-46: Particular requirements
for the basic safety and essential performance of operating
tables
(IEC 60601-2-46:2023)
Appareils électromédicaux - Partie 2-46: Exigences Medizinische elektrische Geräte - Teil 2-46: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des tables d'opération wesentlichen Leistungsmerkmale von Operationstischen
(IEC 60601-2-46:2023) (IEC 60601-2-46:2023)
This European Standard was approved by CENELEC on 2024-07-31. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-46:2024 E

European foreword
The text of document 62D/1939/CDV, future edition 4 of IEC 60601-2-46, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
document have to be withdrawn
This document supersedes EN IEC 60601-2-46:2019 and all of its amendments and corrigenda (if
any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-46:2023 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1-8:2006 NOTE Approved as EN 60601-1-8:2007 (not modified) +A11:2017
IEC 60601-1-8:2006/A1:2012 NOTE Approved as EN 60601-1-8:2007/A1:2013 (not modified)
IEC 60601-1-8:2006/A2:2020 NOTE Approved as EN 60601-1-8:2007/A2:2021 (not modified)
IEC 60601-1-9:2007 NOTE Approved as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Approved as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-9:2007/A2:2020 NOTE Approved as EN 60601-1-9:2008/A2:2020 (not modified)
IEC 60601-1-10:2007 NOTE Approved as EN 60601-1-10:2008 (not modified)
IEC 60601-1-10:2007/A1:2013 NOTE Approved as EN 60601-1-10:2008/A1:2015 (not modified)
IEC 60601-1-10:2007/A2:2020 NOTE Approved as EN 60601-1-10:2008/A2:2021 (not modified)
IEC 60601-1-11:2015 NOTE Approved as EN 60601-1-11:2015 (not modified)
IEC 60601-1-11:2015/A1:2020 NOTE Approved as EN 60601-1-11:2015/A1:2021 (not modified)
IEC 60601-1-12:2014 NOTE Approved as EN 60601-1-12:2015 (not modified)
IEC 60601-1-12:2014/A1:2020 NOTE Approved as EN 60601-1-12:2015/A1:2020 (not modified)
IEC 60601-2-35:2020 NOTE Approved as EN IEC 60601-2-35:2021 (not modified)
IEC 60601-2-52:2009/A1:2015 NOTE Approved as EN 60601-2-52:2010/A1:2015 (not modified)
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
IEC 62366-1:2015/A1:2020 NOTE Approved as EN 62366-1:2015/A1:2020 (not modified)
ISO 7494-1:2018 NOTE Approved as EN ISO 7494-1:2018 (not modified)
ISO 20342-1:2022 NOTE Approved as EN ISO 20342-1:2022 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Replace:
Publication Year Title EN/HD Year
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + AC 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
ISO 2878 2017 Rubber, vulcanized or thermoplastic - - -
Antistatic and conductive products -
Determination of electrical resistance

As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Add:
Publication Year Title EN/HD Year
IEC 60601-2-2 2017 Medical electrical equipment - Part 2-2: EN IEC 60601-2-2 2018
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: EN IEC 60601-2-43 2023
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: EN IEC 60601-2-54 2024
Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy

IEC 60601-2-46 ®
Edition 4.0 2023-05
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
INTERNATIONALE
ICS 11.140  ISBN 978-2-8322-7028-8

– 2 – IEC 60601-2-46:2023 © IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT. 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
202 Electromagnetic disturbances – Requirements and tests . 16
203 *Radiation protection in diagnostic X-ray equipment . 19
Annexes . 20
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 26
Index of defined terms used in this particular standard . 27

Figure 202.101 – ENCLOSURE ad hoc test . 17
Figure 202.102 – POWER SUPPLY CORD ad hoc test . 18
Figure 202.103 – ACCESSORY cable ad hoc test . 18
Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 22
Figure AA.2 – Typical stress-strain curve . 24
Figure AA.3 – Typical bending line along the length L of a beam . 24
Table 201.101 – Determination of TENSILE SAFETY FACTOR . 13
Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 23

IEC 60601-2-46:2023 © IEC 2023 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
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.
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.
– 4 – IEC 60601-2-46:2023 © IEC 2023
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;
– "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.

IEC 60601-2-46:2023 © IEC 2023 – 5 –
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.
– 6 – IEC 60601-2-46:2023 © IEC 2023
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.

IEC 60601-2-46:2023 © IEC 2023 – 7 –
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
– dental PATIENT chairs (see ISO 7494-1),
– examination chairs and couches,
– PATIENT-supporting systems of diagnostic, interventional and therapeutic equipment (see
IEC 60601-2-54 or IEC 60601-2-43),
– OPERATING TABLE heating blankets (see 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.
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 201.3.203.
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.

– 8 – IEC 60601-2-46:2023 © IEC 2023
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.
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 3.154, 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.
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.
IEC 60601-2-46:2023 © IEC 2023 – 9 –
201.2 Normative references
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 60601-1-3:2008, 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.
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 28.
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

– 10 – IEC 60601-2-46:2023 © IEC 2023
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.
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
for OPERATING TABLES: supporting a PATIENT without unintended movement
PERFORMANCE
(motorized or not) leading to an unacceptable RISK in a SINGLE FAULT CONDITION.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
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 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 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.
IEC 60601-2-46:2023 © IEC 2023 – 11 –
201.7 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 ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.21 Mass of MOBILE 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:
HAZARDS related to HIGH
Instructions for use shall include information regarding potential
FREQUENCY SURGICAL EQUIPMENT, cardiac defibrillators and cardiac defibrillator-monitors.
NOTE 101 Potential HAZARDS which 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 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.
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 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 OPERATING TABLES.
Compliance is checked by inspection.

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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.
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.

IEC 60601-2-46:2023 © IEC 2023 – 13 –
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.
TENSILE SAFETY FACTOR
Table 201.101 – Determination of
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 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.
NOTE 101 See Figure AA.1 and Table AA.1 for guidance regarding mass distribution.
Compliance is checked by the following test.

– 14 – IEC 60601-2-46:2023 © IEC 2023
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.
SAFE WORKING LOAD.
2) The load is removed and replaced as soon as practical with
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.
SAFE WORKING LOAD and the OPERATING TABLES
4) The load is removed and replaced with
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.
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.
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 ME
EQUIPMENT
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 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.

IEC 60601-2-46:2023 © IEC 2023 – 15 –
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 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 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:
201.15.4 ME EQUIPMENT components and general assembly
Additional subclause:
201.15.4.101 *Pads for OPERATING TABLES
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 docu
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