EN 60601-2-38:1996

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
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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 MONITORING/COMMUNICATIONS SYSTEMS CONTROL SIDE RAIL
See 2.1.103. CONTROL SIDE RAIL with the addition of PATIENT/OPERATOR station communication
control, and/or PATIENT television/radio entertainment control, and/or PATIENT room lighting
control, and/or PATIENT egress detection system, etc.
2.1.105  HEAD/FOOT PANEL ASSEMBLY
Assemblies mounted to BED end which may be used as handles to push the BED.
2.1.106  MOMENTARY CONTACT SWITCH
Control device which initiates and maintains operation of operating elements only as long as
the control (actuator) is actuated. The manual control (actuator) returns automatically to the
stop position when released. MOMENTARY CONTACT SWITCHES are also known as “hold-to-run
control devices”.
2.1.107  MATTRESS SUPPORT PLATFORM
Structural surface on which the PATIENT sleeping surface (for example mattress) rests in
NORMAL USE. The MATTRESS SUPPORT PLATFORM articulates or changes positions to facilitate
various therapeutic, diagnostic and convenience positions. (See figures 101 and 112.)
*2.1.108  TRENDELENBURG
With the MATTRESS SUPPORT PLATFORM in the flat position, tilting of the entire MATTRESS
SUPPORT PLATFORM a minimum of 12° so that the PATIENT's head is lower than the circulatory
centre point of the body.
2.1.109  SQUEEZING and SHEARING POINTS
Points where the spacing between moveable parts of the BED which in positions of NORMAL USE
fail to maintain a clearance of less than or equal to 8 mm, or greater than or equal to 25 mm.
2.2.101  ELECTRICALLY OPERATED HOSPITAL BED (hereinafter referred to as BED)
BED intended for use in the diagnosis, treatment or monitoring of a PATIENT while under medical
supervision with electrical operation of operating elements.
3 General requirements
This clause of the General Standard applies except as follows:
Addition:
*3.101 If, in order to accomplish other specialized functions which provide benefit to the
PATIENT, it is not technically feasible to meet specific requirements in this Particular Standard,
the BED shall be accepted only if clear and specific instructions (in the INSTRUCTIONS FOR USE)
restrict the NORMAL USE of the BED so that no SAFETY HAZARD exists.

601-2-38 © IEC:1996 – 15 −
BEDS with active therapeutic/prophylaxis MATTRESS SUPPORT PLATFORM, such as air fluidized, air
mattress, or water surfaces and/or INTEGRATED PATIENT MONITORING/COMMUNICATION CONTROL
SIDE RAIL are excluded from the requirements of 5.3, 54.101 of this Particular Standard.
5 Classification
This clause of the General Standard applies except as follows:
*5.2  Replacement:
BEDS shall be EQUIPMENT with TYPE B or BF APPLIED PART.
*5.3  Replacement:
BEDS shall be at least IPX4 in accordance with IEC 529.
6  Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1  Marking on the outside of EQUIPMENT or EQUIPMENT PARTS
l)  Classification
Addition:
− BEDS intended for use with "jet stream" washing machines, high pressure/steam cleaning,
etc. shall be so marked.
u)  Mechanical stability
Replacement:
The BED shall be marked with its SAFE WORKING LOAD. (See figure 108.)
w)  Warnings
Replacement:
When text is used for warning notices, they shall be in the official language of the country
where the BED is placed on the market.
6.4  Symbols
Addition:
aa) Controls and/or indicators, when possible, should be marked using symbols which will
convey the intended function of those controls or indicators without the need for additional
text.
NOTE − Figures 107 and 108 are intended as guidelines when designing these symbols. In all cases where
standard international symbols exist, they should be used.

601-2-38 © IEC:1996 – 17 −
6.8.2  Instructions for use
a)  General information
Addition:
– Complete instructions for use shall be provided which ensure the safe operation of the
BED.
– SAFE WORKING LOAD of the BED.
– Mass of the BED.
– Recommended frequency of periodic inspection and maintenance of the BED. It is
recommended that frequency of inspection be at least annually.
– If the BED or parts of the BED which can come into contact with the PATIENT are intended
for use in jet stream and/or high pressure steam cleaning equipment the permissible range
of temperature, spray pressure and allowable chemical application shall be given.
–For BEDS designed for “jet stream” washing machines, high pressure/steam cleaning,
which require inspection after the cleaning procedure, the ACCOMPANYING DOCUMENTS shall
contain instructions how to insure that NORMAL CONDITIONS are still valid.
– Instructions for use shall identify the maximum angles which can be achieved in NORMAL
USE by each part of the MATTRESS SUPPORT PLATFORM with reference to horizontal. They
shall also identify the maximum and minimum heights from the floor which can be achieved
by the MATTRESS SUPPORT PLATFORM in NORMAL USE.
b)  Responsibility of the manufacturer
Addition:
Instructions for use shall include a statement on SAFETY HAZARDS which may arise due to
improper handling of POWER SUPPLY CORDS, e.g.: driving over cables or cords, crushing
between HEAD/FOOT PANEL ASSEMBLY and movable parts.
Additional item:
* aa) If a means to deactivate movement of the APPLIED PARTS (excluding non-energized
ACCESSORIES) or MATTRESS SUPPORT PLATFORM is employed to prevent SAFETY HAZARDS
created by SINGLE FAULT CONDITIONS, the instructions for use shall include clear directions on
how to deactivate any BED function which might cause injury to the PATIENT if movement
occurs.
SECTION TWO – ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.
SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
17  Separation (Previous title: Insulation and protective impedances)
*c) Replacement:
A type BF APPLIED PART shall have no CONDUCTIVE CONNECTION to ACCESSIBLE METAL PARTS.

601-2-38 © IEC:1996 – 19 −
18  Protective earthing, functional earthing and potential equalization
*e) Addition:
− ACCESSIBLE METAL PARTS of APPLIED PARTS which are intended for use together with
MEDICAL ELECTRICAL EQUIPMENT connected intravascularly or intracardially to the PATIENT
shall be provided with a means for potential equalization connection.
– ACCESSIBLE METAL PARTS of APPLIED PARTS shall have an impedance of less than 0,2 Ω
with respect to the potential equalization connection.
Compliance is checked by measurement.
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
21  Mechanical strength
This clause of the General Standard applies except as follows:
Addition:
21.3.101 The SAFE WORKING LOAD of the BED shall be listed in the instructions for use and shall
be at least 1700 N. This 1700 N load is considered to be the sum of the following:
− 1350 N (PATIENT);
− 200 N (mattress);
− 150 N (ACCESSORIES).
(For testing purposes the load shall be distributed as shown in figure 102.)
21.6  Replacement:
BEDS which are intended to be mobile while accommodating a PATIENT shall be subjected to the
following:
Impact test – The BED, with HEAD/FOOT PANEL ASSEMBLIES mounted and SAFE WORKING LOAD in
place, shall withstand, without permanent deformation or loss of NORMAL USE, three impacts to
each end of the BED against a solid hardwood (e.g. oak) vertical wall with the BED moving at a
speed of (0,4 ± 0,1) m/s without loss of NORMAL USE.
*21.6.101 The HEAD/FOOD PANEL ASSEMBLIES shall withstand a static force of 450 N applied
along the longitudinal axis of the BED and at the location(s) defined in the ACCOMPANYING
DOCUMENTS as transport handholds/push points or, if these points are not defined, the force
shall be applied horizontally and centrally at the highest extremity of the HEAD/FOOT PANEL. The
load shall be applied over an area of 625 mm . The test shall be applied for 30 s ten times,
forwards and backwards, without material failure.
21.6.102  Threshold test
BEDS shall withstand the stresses caused by rough handling.

601-2-38 © IEC:1996 – 21 −
Compliance with this requirement is checked by the following test:
The BED, with the SAFE WORKING LOAD in place, shall be moved ten times in forward direction
as in NORMAL USE. All castors shall impact a solid vertical plane obstruction which is fixed
flat on the floor with a rectangular cross-section, 20 mm high and 80 mm deep at a speed of
(0,4 ± 0,1) m/s without loss of function.
22  Moving parts
This clause of the General Standard applies except as follows:
Addition:
*22.2.101 Exposed SQUEEZING and SHEARING POINTS which could constitute a SAFETY HAZARD
are permissible for moveable parts below the MATTRESS SUPPORTING PLATFORM if their distance
from the outermost rigid edge of the MATTRESS SUPPORTING PLATFORM (towards the inside) is
200 mm or greater. The 200 mm distance shall be measured around any barrier which
separates the PATIENT from a safety hazard. (See figures 109 and 110.)
Parts moved vertically which could create a SAFETY HAZARD shall maintain perpendicular
clearances to the floor of at least 120 mm unless their distance from the outermost rigid edge of
the MATTRESS SUPPORTING PLATFORM (towards the inside) is 120 mm or greater.
22.2.102 All BEDS shall incorporate means to deactivate BED function control (BED movement)
available to the PATIENT.
The means to deactivate BED movement shall be located such that a PATIENT can not
accidentally re-activate any functions.
22.4.101 Electrically powered functional movements of the BED shall be possible only by
means of MOMENTARY CONTACT SWITCHES.
Replacement:
22.5 End stops or other means to limit movement shall be provided and their strength shall
be adequate for the intended function. Compliance is checked by review of the manufacturer´s
design and test data.
24  Stability in NORMAL USE
This clause of the General Standard applies except as follows:
24.3  Addition:
*aa) With the BED, castors and side rails (if either are incorporated in the BED design) in their
worst case position of NORMAL USE and the SAFE WORKING LOAD in place (as shown in
figure 102), the BED shall not overbalance when:
– Lateral stability test:
A load of 2250 N is located on the edge of the flat MATTRESS SUPPORT PLATFORM, centred at
a distance 125 mm from the outer edge. (See figures 103/105.)
– Longitudinal stability test:
A load of 1500 N is located at the foot end of the MATTRESS SUPPORT PLATFORM centred at a
distance 125 mm from the outer edge. (See figures 104/106.)

601-2-38 © IEC:1996 – 23 −
24.4 The BED shall be fitted with means (such as locking devices on castors) to prevent any
self-movement (with respect to the floor) in the transport position of the BED.
Compliance is checked by following test:
The BED is placed in its transport position (or in the worst case NORMAL USE position if no
transport position is defined in the INSTRUCTIONS FOR USE) with the SAFE WORKING LOAD in place
(as shown in figure 102), and the locking device (e.g.: brakes) applied, on a surface inclined at
10° from horizontal. If the BED incorporates pivoting casters, they shall be pivoting to their worst
case position. No movement of the BED greater than 10 mm (in relation to the inclined surface)
shall occur.
26  Vibration and noise
This clause of the General Standard applies except as follows:
Addition:
26.101 The noise of movement of the BED with the SAFE WORKING LOAD in place (see
figure 102) should not exceed 65 dB(A) at a distance of one meter. If this requirement is not
met, a statement shall be placed in the USER’s manual indicating maximum sound pressure
levels produced in NORMAL USE.
Compliance is checked by measurements made in accordance with ISO 2204.
28  Suspended masses
This clause of the General Standard applies except as follows:
28.4  Suspension systems of metal without SAFETY DEVICES
2)  Replacement:
The BED shall be capable of withstanding a uniformly distributed static load equal to twice
the SAFE WORKING LOAD or 4000 N, wh
...