EN 60601-2-38:1996

Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

Specifies requirements for safety of electrically operated hospital beds. The object of this standard is to keep the safety hazards to patients, operators and the environment as low as possible, and to describe tests to verify that these requirements are attained.

Medizinische elektrische Geräte - Teil 2-38: Besondere Festlegungen für die Sicherheit von elektrisch betriebenen Krankenhausbetten

Appareils électromédicaux - Partie 2-38: Règles particulières de sécurité des lits d'hôpital électriques

Spécifie les règles de sécurité relatives aux lits d'hôpital électriques. L'objet de cette norme est de minimiser autant que possible les risques pour les patients, les opérateurs et l'environnement, et de décrire les essais servant à vérifier que les prescriptions sont satisfaites.

Medicinska električna oprema - 2-38. del: Posebne varnostne zahteve za električno nastavljive bolnišnične postelje (IEC 60601-2-38:1996)

General Information

• Status: Withdrawn
• Publication Date: 15-Dec-1996
• Withdrawal Date: 12-Jun-1998
• 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: 01-Apr-2013
• Completion Date: 01-Apr-2013
• 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 60601-2-38:1998 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996)

Relations

• Replaced By: EN 60601-2-52:2010 - Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-38:1996/A1:2000 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-38:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DHOHNWULþQR
QDVWDYOMLYHEROQLãQLþQHSRVWHOMH,(&
Medical electrical equipment - Part 2-38: Particular requirements for the safety of
electrically operated hospital beds (IEC 60601-2-38:1996)
Medizinische elektrische Geräte - Teil 2-38: Besondere Festlegungen für die Sicherheit
von elektrisch betriebenen Krankenhausbetten (IEC 60601-2-38:1996)
Appareils électromédicaux - Partie 2-38: Règles particulières de sécurité des lits d'hôpital
électriques (CEI 60601-2-38:1996)
Ta slovenski standard je istoveten z: EN 60601-2-38:1996
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 60601-2-38:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-38:1998

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SIST EN 60601-2-38:1998

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SIST EN 60601-2-38:1998

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SIST EN 60601-2-38:1998

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SIST EN 60601-2-38:1998

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SIST EN 60601-2-38:1998
NORME
CEI
INTERNATIONALE
IEC
601-2-38
INTERNATIONAL
Première édition
STANDARD
First edition
1996-10
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité
des lits d’hôpital électriques
Medical electrical equipment –
Part 2:
Particular requirements for the safety
of electrically operated hospital beds
 CEI 1996  Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized
utilisée sous quelque forme que ce soit et par aucun procédé, in any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission
microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher
Bureau central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, Suisse
CODE PRIX
Commission Electrotechnique Internationale
V
International Electrotechnical Commission PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-38:1998
601-2-38 © IEC:1996 – 3 −
CONTENTS
Page
FOREWORD . 7
Clause
SECTION ONE – GENERAL
1 Scope and object. 9
2 Terminology and definitions . 11
3 General requirements . 13
5 Classification . 15
6 Identification, marking and documents . 15
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
17 Separation. 17
18 Protective earthing, functional earthing and potential equalization . 19
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 19
22 Moving parts. 21
24 Stability in NORMAL USE . 21
26 Vibration and noise. 23
28 Suspended masses . 23
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility. 23
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization
and disinfection . 25
SECTION EIGHT – ACCURACY OF OPERATING DATA AN
...