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• Status: Withdrawn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
01-september-1998
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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CODE PRIX
Commission Electrotechnique Internationale
V
International Electrotechnical Commission PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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 AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions. 27

601-2-38 © IEC:1996 – 5 −
Clause Page
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General. 27
56 Components and general assembly . 27
57 MAINS PARTS, components and layout. 29
Figures
101 ELECTRICALLY OPERATED HOSPITAL BED, general arrangement. 31
102 Distribution of the SAFE WORKING LOAD for tests. 33
103 Lateral stability test: load arrangement (plan view). 35
104 Longitudinal stability test: load arrangement (plan view). 37
105 Lateral stability test: load arrangement (end elevation). 39
106 Longitudinal stability test: load arrangement (side elevation) . 41
107 BED function controls and/or actuators: guidelines for creating graphic symbols. 43
108 Graphic symbol for SAFE WORKING LOAD . 45
109 Typical spacings for SQUEEZING and SHEARING POINTS . 45
110 Clearance measurements around barriers. 47
111 APPLIED PARTS region and potential equalization. 47
112 Minimum angle between the back and leg/upper leg sections for various
configurations of the MATTRESS SUPPORT PLATFORM . 49
Annexes
L References – Publications mentioned in this standard. 51
AA Guidance and rationale for particular subclauses . 53
BB Possible considerations and tests for ELECTRICALLY OPERATED HOSPITAL BEDS. 57

601-2-38 © IEC:1996 – 7 −
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
electrically operated hospital beds
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international co-operation on all questions concerning standardization in the electrical and electronic
fields. To this end and in addition to other activities, the IEC publishes International Standards. Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt
with may participate in this preparatory work. International, governmental and non-governmental organizations
liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International
Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
two organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the
form of standards, technical reports or guides and they are accepted by the National Committees in that
sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 601-2-38 has been prepared by subcommittee 62D: Electro-medical
equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/192/FDIS 62D/214/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annexes AA and BB are for information only.
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 601-1 OR THIS PARTICULAR
STANDARD: SMALL CAPITALS.
601-2-38 © IEC:1996 – 9 −
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
electrically operated hospital beds
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies, except as follows:
1.1  Scope
Addition:
This Particular Standard specifies requirements for safety of ELECTRICALLY OPERATED HOSPITAL
BEDS, hereinafter referred to as BED, as defined in 2.2.101.
1.2  Object
Replacement:
The object of this Particular Standard for BEDS 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.
1.3  Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter
referred to as “General Standard”, consisting of IEC 601-1: 1988, Medical electrical equipment
, amendment 1, amendment 2 and IEC 601-1-1: 1992,
– Part 1: General requirements for safety
Medical electrical equipment – Part 1 : General requirements for safety − 1. Collateral
Standard: Safety requirements for medical electrical systems.
For brevity, IEC 601-1 is referred to in this Particular Standard either as the “General Standard”
or as the “General Requirement(s)”, and IEC 601-1-1 as the “Collateral Standard”.
The term “this Standard” covers the Particular Standard, used together with the General
Standard and any Collateral Standards.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. The changes to the text of the General Standard are
specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.

601-2-38 © IEC:1996 – 11 −
“Addition” means that the text of this Particular Standard is additional to the requirements of the
General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk *. These
rationales can be found in an informative annex AA. Annex AA should be used in determining
the relevance of the requirements addressed, but should never be used to establish additional
test requirements.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or the Collateral Standard applies without
modification.
Where it is intended that any part of the General Standard or the Collateral Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard or the Collateral Standard takes precedence over the corresponding General
Requirement(s).
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5  APPLIED PART
Replacement:
All parts of the BED which can intentionally or unintentionally come into contact with the
PATIENT, are considered an APPLIED PART. (See figure 111.)
Additional definitions:
2.1.101  PENDANT CONTROL
Means, used by either PATIENT or OPERATOR to control the drives that activate various BED
functions.
2.1.102  SIDE RAIL
Rail mounted to both sides of the BED which, when located in the “up” position, identifies the
edge of the MATTRESS SUPPORT PLATFORM and by doing so, reduces the risk of the PATIENT
accidentally slipping or rolling off the mattress.
2.1.103  CONTROL SIDE RAIL
SIDE RAIL which incorporates BED function controls for PATIENT activation.

601-2-38 © IEC:1996 – 13 −
2.1.104 INTEGRATED PATIENT MON
...