prEN IEC 60601-2-46:2022

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.

Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationstischen

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.

Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz

General Information

• Status: Not Published
• Publication Date: 16-Oct-2023
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 17-Jun-2022
• Completion Date: 17-Jun-2022
• 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: oSIST prEN IEC 60601-2-46:2022 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

Relations

• Revises: EN IEC 60601-2-46:2019 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 08-Feb-2022

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-46:2022
01-maj-2022
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tables
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationstischen
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération
Ta slovenski standard je istoveten z: prEN IEC 60601-2-46:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 60601-2-46:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 60601-2-46:2022

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oSIST prEN IEC 60601-2-46:2022
62D/1939/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-46 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-03-25 2022-06-17
SUPERSEDES DOCUMENTS:
62D/1866/CD, 62D/1935/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.

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

PROPOSED STABILITY DATE: 2027

NOTE FROM TC/SC OFFICERS:
This revision project is to align with the Amendment projects of the IEC 60601 -1 series and to address some
technical updates to ED3. NCs are invited to submit their votes and comments at the CDV stage.
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.

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oSIST prEN IEC 60601-2-46:2022
62D/1939/CDV – 2 – IEC CDV 60601-2-46 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 5
5 201.1 Scope, object and related standards . 6
6 201.2 Normative references . 8
7 201.3 Terms and definitions . 8
8 201.4 General requirements . 9
9 201.5 General requirements for testing ME EQUIPMENT . 9
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
11 201.7 ME EQUIPMENT identification, marking and documents . 9
12 201.8 Protection against electrical HAZARDS from OPERATING TABLES . 10
13 201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and
14 ME SYSTEMS . 10
15 201.10 Protection against unwanted and excessive radiation HAZARDS . 13
16 NOTE : The collateral standard IEC 60601-1-3 is referenced in the general standard
17 and is cov
...