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
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
...