EN 60601-2-46:1998

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

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.

Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit von Operationstischen

Appareils électromédicaux - Partie 2-46: Règles particulières de sécurité pour les tables d'opération

Medicinska električna oprema - 2-46. del: Posebne varnostne zahteve za operacijske mize (IEC 60601-2-46:1998)

General Information

• Status: Withdrawn
• Publication Date: 13-Aug-1998
• Withdrawal Date: 30-Apr-2001
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 20-Jan-2014
• Completion Date: 20-Jan-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-46:2002 - Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998)

Relations

• Replaced By: 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: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-46:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
RSHUDFLMVNHPL]H,(&
Medical electrical equipment - Part 2-46: Particular requirements for the safety of
operating tables (IEC 60601-2-46:1998)
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
von Operationstischen (IEC 60601-2-46:1998)
Appareils électromédicaux - Partie 2-46: Règles particulières de sécurité pour les tables
d'opération (CEI 60601-2-46:1998)
Ta slovenski standard je istoveten z: EN 60601-2-46:1998
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 60601-2-46:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002

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SIST EN 60601-2-46:2002
INTERNATIONAL
IEC
STANDARD
60601-2-46
First edition
1998-06
Medical electrical equipment –
Part 2-46:
Particular requirements for the safety
of operating tables
Appareils électromédicaux –
Partie 2-46:
Règles particulières de sécurité
pour les tables d’opération
 IEC 1998  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
R
International Electrotechnical Commission
For price, see current catalogue

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SIST EN 60601-2-46:2002
– 2 – 60601-2-46 © IEC:1998(E)
CONTENTS
Page
FOREWORD . 4
INTRODUCTION . 5
SECTION ONE – GENERAL
Clause
1 Scope and object . 6
2 Terminology and definitions . 7
4 General requirements for tests . 8
5 Classification . 8
6 Identification, marking and documents. 8
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 Separation . 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 10
20 Dielectric strength . 10
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 10
22 Moving parts . 11
24 Stability in NORMAL USE . 11
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-Radiation . 12
36 Electromagnetic compatibility . 12
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT . 13
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection. 13
49 Interruption of the power supply . 13
...