IEC 60601-2-46:2016

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

IEC 60601-2-46:2016 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 third edition cancels and replaces the second edition published in 2010 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1 and with IEC 60601-1:2005/AMD1:2012.

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

L'IEC 60601-2-46:2016 spécifie les exigences de sécurité applicables aux tables d'opération, que celles-ci comportent ou non des parties électriques, y compris les chariots de transfert, utilisés pour le transport du plateau de la table d'opération vers ou depuis la base ou le socle d'une table d'opération à plateau mobile. Cette troisième édition annule et remplace la deuxième édition parue en 2010. Cette édition constitue une révision technique. La présente édition de l'IEC 60601-2-46 a été révisée de façon à s'aligner sur la structure de l'édition 2005 de l'IEC 60601-1 et de l'IEC 60601-1:2005/AMD1:2012.

General Information

• Status: Published
• Publication Date: 09-Aug-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.140 - Hospital equipment
• ICS: 17.220.20 - Measurement of electrical and magnetic quantities
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 28 - TC 62/SC 62D/MT 28
• Current Stage: DELPUB - Deleted Publication
• Start Date: 30-Jun-2021
• Completion Date: 26-May-2023

Relations

• Revises: IEC 60601-2-46:2010 - Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-46:2023 - 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 3.0 2016-08
REDLINE 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

your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]

CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

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IEC 60601-2-46 ®
Edition 3.0 2016-08
REDLINE 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 978-2-8322-3581-2

– 2 – IEC 60601-2-46:2016 RLV © IEC 2016

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 OPERATING TABLES . 10
201.6 Classification of ME EQUIPMENT OPERATING TABLES and ME SYSTEMS. 10
201.7 ME EQUIPMENT OPERATING TABLES identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT OPERATING TABLES . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT OPERATING TABLES
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 OPERATING TABLES . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT OPERATING TABLES . 15
201.16 ME SYSTEMS . 15
201.17 Electromagnetic compatibility of ME EQUIPMENT OPERATING TABLES and
ME SYSTEMS . 16
202 Electromagnetic compatibility disturbances – Requirements and tests . 16
203 Radiation protection in diagnostic X-ray equipment. 20
Annexes . 21
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 22
Annex AA (informative) Particular guidance and rationale . 23
Bibliography . 25
Index of defined terms used in this particular standard . 26

Figure 202.101 – ENCLOSURE ad hoc test . 18
Figure 202.102 – POWER SUPPLY CORD ad hoc test . 19
Figure 202.103 – ACCESSORy cable ad hoc test. 19
Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 23

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 . 24

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 redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.

– 4 – IEC 60601-2-46:2016 RLV  IEC 2016

International standard IEC 60601-2-46 has been prepared by IEC subcommittee 62D

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2010 and constitutes a
technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the

2005 edition of IEC 60601-1 and with IEC 60601-1:2005/AMD1:2012.

The text of this standard is based on the following documents:

FDIS Report on voting
62D/1365/FDIS 62D/1371/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this p
...

IEC 60601-2-46 ®
Edition 3.0 2016-08
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
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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 corrigenda or an amendment might have been published.

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Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

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IEC 60601-2-46 ®
Edition 3.0 2016-08
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 978-2-8322-3565-2

– 2 – IEC 60601-2-46:2016  IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing OPERATING TABLES . 9
201.6 Classification of OPERATING TABLES and ME SYSTEMS . 9
201.7 OPERATING TABLES identification, marking and documents. 9
201.8 Protection against electrical HAZARDS from OPERATING TABLES . 10
201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and
ME SYSTEMS . 10
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 HAZARDOUS SITUATIONS and fault conditions for OPERATING TABLES . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of OPERATING TABLES . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of OPERATING TABLES and ME SYSTEMS . 14
202 Electromagnetic disturbances – Requirements and tests . 14
203 Radiation protection in diagnostic X-ray equipment . 18
Annexes . 19
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 20
Annex AA (informative) Particular guidance and rationale . 21
Bibliography . 23
Index of defined terms used in this particular standard . 24

Figure 202.101 – ENCLOSURE ad hoc test . 16
Figure 202.102 – POWER SUPPLY CORD ad hoc test . 17
Figure 202.103 – ACCESSORy cable ad hoc test . 17
Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 21

Table 201.101 – Determination of TENSILE SAFETY FACTOR . 12
Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 22

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.
International standard IEC 60601-2-46 has been prepared by IEC subcommittee 62D
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2010 and constitutes a
technical revision. This edition of IEC 60601-2-46 was revised to align st
...