SIST EN IEC 60601-2-46:2024

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (IEC 60601-2-46:2023)

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.

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)

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.

Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz (IEC 60601-2-46:2023)

General Information

• Status: Published
• Public Enquiry End Date: 31-May-2022
• Publication Date: 03-Oct-2024
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Sep-2024
• Due Date: 30-Nov-2024
• Completion Date: 04-Oct-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: EN IEC 60601-2-46:2024 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

Relations

• Revised: SIST EN IEC 60601-2-46:2020 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (IEC 60601-2-46:2016)
• Effective Date: 08-Feb-2022

Standards Content (Sample)

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
...