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 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. 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.
IEC 60601-2-46:2023 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.

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

L'IEC 60601-2-46:2023 spécifie les exigences de sécurité applicables aux tables d'opération, que celles-ci comportent ou non des parties électriques, y compris les chariot de transfert, utilisés pour le transport du plateau de la table d'opération vers ou depuis la base ou le socle d'une table d'opération à plateau amovible. La présente norme particulière ne s’applique pas:
- aux fauteuils dentaires pour patients (voir l’ISO 7494-1),
- aux fauteuils et lits d'examen,
- aux systèmes de support du patient des appareils de diagnostic, d’intervention et de thérapie (voir l’IEC 60601-2-54 ou l’IEC 60601-2-43),
- aux couvertures chauffantes des tables d'opération (voir l’IEC 60601-2-35),
- aux appareils de transfert des patients,
- aux tables et lits d'accouchement,
- aux lits médicaux (voir l’IEC 60601-2-52 et l’EN 50637), et
- aux tables d'opération de campagne.
L'IEC 60601-2-46:2023 annule et remplace la troisième édition parue en 2016. Cette édition constitue une révision technique. La présente édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente: alignement de la structure sur l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601-1:2005/AMD2:2020.

General Information

• Status: Published
• Publication Date: 25-May-2023
• 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: PPUB - Publication issued
• Start Date: 22-Jun-2023
• Completion Date: 26-May-2023

Relations

• Revises: 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

Standards Content (Sample)

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

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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
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.
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
reasons of the most relevant changes, or to clarify any part of the content.
A vertical bar appears in the margin wherever a change has been made. Additions are in
green text, deletions are in strikethrough red text. Experts' comments are identified by a
blue-background number. Mouse over a number to display a pop-up note with the
comment.
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 th
...

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

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and French, with equivalent terms in 19 additional languages.
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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

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 repo
...