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IEC 60601-2-46:2023

(Main)

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

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
Ref Project

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

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IEC 60601-2-46:2023 CMV - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables Released:5/26/2023IEC 60601-2-46:2023 CMV - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables Released:5/26/2023
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IEC 60601-2-46:2023 CMV - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables Released:5/26/2023
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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
IEC 60601-2-46:2023-05 CMV(en)

---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
 Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission

---------------------- Page: 3 ----------------------
– 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
...

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