EN IEC 60601-2-46:2019

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

IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 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.

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

La CEI 60601-2-46:2010 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 vers ou depuis la base ou le socle d'une table d'opération à plateau mobile. Cette deuxième édition annule et remplace la première édition parue en 1998, et constitue une révision technique. La présente édition de la CEI 60601-2-46 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1.

Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz (IEC 60601-2-46:2016)

Standard IEC 60601-2-46:2010 določa posebne varnostne zahteve za operacijske mize z električnimi deli ali brez njih, vključno s transporterji, ki se uporabljajo za premik mizne ploskve do podstavka oziroma stojala operacijske mize z odstranljivo mizno ploskvijo ali stran od njega. Ta druga izdaja razveljavlja in nadomešča prvo izdajo, objavljeno leta 1998, in predstavlja tehnično popravljeno izdajo. Ta izdaja standarda IEC 60601-2-46 je bila revidirana in strukturno usklajena z izdajo standarda IEC 60601-1:2005.

General Information

• Status: Published
• Publication Date: 14-Nov-2019
• Withdrawal Date: 14-Nov-2022
• 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: 6060 - Document made available - Publishing
• Start Date: 15-Nov-2019
• Completion Date: 15-Nov-2019
• 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• 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: 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)

Relations

• Replaces: EN 60601-2-46:2011 - Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
• Effective Date: 19-Nov-2019
• Revised: prEN IEC 60601-2-46:2022 - 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
SIST EN IEC 60601-2-46:2020
01-januar-2020
Nadomešča:
SIST EN 60601-2-46:2011
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz (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)
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationstischen (IEC 60601-2
-46:2016)
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération (IEC 60601-2-46:2016)
Ta slovenski standard je istoveten z: EN IEC 60601-2-46:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2-46:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-46:2020

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SIST EN IEC 60601-2-46:2020


EUROPEAN STANDARD EN IEC 60601-2-46

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2019
ICS 11.140 Supersedes EN 60601-2-46:2011 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-46: Particular requirements
for the basic safety and essential performance of operating
tables
(IEC 60601-2-46:2016)
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 60601-2-46:2016) (IEC 60601-2-46:2016)
This European Standard was approved by CENELEC on 2016-09-14. 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,
Turkey 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-46:2019 E

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SIST EN IEC 60601-2-46:2020
EN IEC 60601-2-46:2019 (E)
European foreword
The text of document 62D/1365/FDIS, future edition 3.0 of IEC 60601-2-46, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-46:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-15
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-11-15
document have to be withdrawn

This document supersedes EN 60601-2-46:2011 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.

Endorsement notice
The text of the International Standard IEC 60601-2-46:2016 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 standards
indicated:
IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8
IEC 60601-1-10:2007 NOTE Harmonized as EN 60601-1-10:2008 (not modified)
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:201
...