SIST EN 60601-2-52:2010

SLOVENSKI STANDARD
01-junij-2010
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Medical electrical equipment - Part 2-52: Particular requirements for basic safety and
essential performance of medical beds (IEC 60601-2-52:2009)
Medizinische elektrische Geräte - Teil 2-52: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Betten (IEC
60601-2-52:2009)
Appareils électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et
de performances essentielles des lits médicaux (CEI 60601-2-52:2009)
Ta slovenski standard je istoveten z: EN 60601-2-52:2010
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-52
NORME EUROPÉENNE
April 2010
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 60601-2-38:1996 + A1:2000, EN 1970:2000

English version
Medical electrical equipment -
Part 2-52: Particular requirements for basic safety and essential
performance of medical beds
(IEC 60601-2-52:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-52: Exigences particulières Teil 2-52: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des lits médicaux von medizinischen Betten
(CEI 60601-2-52:2009) (IEC 60601-2-52:2009)

This European Standard was approved by CENELEC on 2010-04-01. 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 Central Secretariat 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CEN-CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2010 CEN-CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CEN-CENELEC members.
Ref. No. EN 60601-2-52:2010 E
Foreword
The text of document 62D/795/FDIS, future edition 1 of IEC 60601-2-52, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-52 on 2010-04-01.
This European Standard supersedes EN 60601-2-38:1996 + A1:2000 and EN 1970:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-04-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-52:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standards indicated:
IEC 60601-2-38 NOTE  Harmonized as EN 60601-2-38
__________
- 3 - EN 60601-2-52:2010
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Addition to Annex ZA of EN 60601-2:
Publication Year Title EN/HD Year

IEC 60068-2-31 2008 Environmental testing - EN 60068-2-31 2008
Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type
specimens
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association and within its scope the
standard covers all relevant essential requirements as given in Annex I of the EC Directive
93/42/EEC except the following:
– Essential Requirement 7.1
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products
falling within the scope of this standard.

IEC 60601-2-52
Edition 1.0 2009-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-52: Particular requirements for the basic safety and essential performance
of medical beds
Appareils électromédicaux –
Partie 2-52: Exigences particulières de sécurité de base et de performances
essentielles des lits médicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.140 ISBN 2-8318-1068-1
– 2 – 60601-2-52 © IEC:2009
CONTENTS
FOREWORD.5
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references.9
201.3 Terms and definitions.10
201.4 General requirements .13
201.5 General requirements for testing of ME EQUIPMENT .13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS.15
201.7 ME EQUIPMENT identification, marking and documents .15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .21
201.10 Protection against unwanted and excessive radiation HAZARDS .44
201.11 Protection against excessive temperatures and other HAZARDS .44
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .46
201.13 HAZARDOUS SITUATIONS and fault conditions .47
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47
201.15 Construction of ME EQUIPMENT .48
201.16 ME SYSTEMS .51
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .51
Annexes .51
Annex AA (informative) Particular guidance and rationale.52
Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS.67
Annex CC (informative) Particular guidance for assessing risk of entrapment in v-
shaped openings .75
Bibliography.81
Index of defined terms used in this particular standard.82

Figure 201.101 – APPLIED PART.10
Figure 201.102 – MEDICAL BED, general arrangement (example, schematic presentation
only) .
Figure 201.103a – Cone tool.14
Figure 201.103b – Cylinder tool .14
Figure 201.103 – Entrapment test tools.14
Figure 201.104 – Loading pad .15
Figure 201.105 – Graphic symbol for maximum PATIENT weight and SAFE WORKING
LOAD .16
Figure 201.106 – MEDICAL BED function controls and/or actuators: guidelines for
creating graphic symbols .18
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL .22
Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL .23
Figure 201.109 – Allowable spacing for fingers in areas of normal reach around the
MATTRESS SUPPORT PLATFORM .28
perimeter of the
60601-2-52 © IEC:2009 – 3 –
Figure 201.110 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment .29
Figure 201.111a – Foot and toe clearance area between moving parts and the floor.29
Figure 201.111b – Toe clearance area between moving parts and the floor .30
Figure 201.111 – Clearance areas .30
Figure 201.112 – Lateral stability test along the side of the MEDICAL BED.32
Figure 201.113 – Longitudinal stability test with removable FOOT BOARD .32
Figure 201.114 – Longitudinal stability test with fixed HEAD/FOOT BOARDS.33
Figure 201.115 – Distribution of SAFE WORKING LOAD for tests.37
Figure 201.116 – Position of loading pad (see Figure 201.104).40
Figure 201.117 – Application of forces for test of SIDE RAIL.42
Figure 201.118 – Height of SIDE RAIL .43
Figure 201.119a – Angle γ between the back section and the leg section of the
MATTRESS SUPPORT PLATFORM.49
Figure 201.119b – Angle γ between the back section and the upper leg section of the
MATTRESS SUPPORT PLATFORM.49
Figure 201.119c – Angle γ between the angled back section and upper leg section of
MATTRESS SUPPORT PLATFORM .49
the
Figure 201.119d – Angle γ between the angled back section and the leg/upper leg
section of the MATTRESS SUPPORT PLATFORM .50
Figure 201.119 – Configurations of the MATTRESS SUPPORT PLATFORM .50
Figure AA.1 – Marking to select recommended mattresses specified by the
MANUFACTURER.54
Figure AA.2 – Marking for detachable SIDE RAILS specified by the MANUFACTURER .54
Figure AA.3 – Resultant forces without mattress .58
Figure AA.4 – Resultant forces with mattress.58
Figure AA.5 – Example of 60 mm gap measurement of B.58
Figure AA.6 – Angle measurement example of B .58
Figure AA.7 – Placement of measurement TOOL for measurement of D .59
Figure AA.8 – Example of area D measurement that passes .59
Figure AA.9 – Example of area D measurement that fails.59
Figure AA.10 – Example of area D measurement that fails (on limit) .60
Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL .60
Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL .60
Figure AA.13 – Example of potential PATIENT entrapment in area B.60
Figure AA.14 – Example of potential PATIENT entrapment in area C between split SIDE
RAIL .60
Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL
and HEAD BOARD .61
Figure AA.16 – Example of potential PATIENT entrapment in area D.61
Figure AA.17 – Example of potential PATIENT entrapment in area A below a single
piece SIDE RAIL .61
Figure BB.1 – Other areas of possible impact testing.68
Figure BB.2 – Impactor .69
Figure BB.3 – Schematic presentation of under MEDICAL BED clearance.72

– 4 – 60601-2-52 © IEC:2009
Figure BB.4 – Recommendations and requirements regarding angles for different
sections of the MATTRESS SUPPORT PLATFORM .74
Figure CC.1 – Wedge tool.76
Figure CC.2 – V-shaped opening in relation to B.77
Figure CC.3 – Pass/fail in relation to area B .77
Figure CC.4 – Positioning of wedge tool .78
Figure CC.5 – Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD.79
Figure CC.6 – Pass/fail in relation to area C between split SIDE RAILS .80

Table 201.101 – Protection against PATIENT entrapment .24
Table 201.102 – Protection against inadvertent PATIENT falls .44
Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED
PARTS.45
Table BB.1 – Normative and informative requirements for different APPLICATION
ENVIRONMENTS 1 to 5 .67

60601-2-52 © IEC:2009 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-52 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and by ISO technical committee 173: Assistive products for persons with disability.
It is published as double logo standard.
This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996,
and its Amendment 1 (1999). This edition constitutes a technical revision.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/795/FDIS 62D/815/RVD
– 6 – 60601-2-52 © IEC:2009
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. In ISO, the standard has been approved by
20 P-members out of 20 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-52 © IEC:2009 – 7 –
INTRODUCTION
In 1996, the IEC published the first edition of the particular standard for electrically operated
hospital beds, IEC 60601-2-38. The publication was in response to demand in the field for a
universal standard addressing HAZARDS specific to the safety of the hospital bed. Used in
conjunction with a MANUFACTURER’S RISK ASSESSMENT, the standard was felt to be the current
thinking on establishing a basic safety benchmark for industry.
An amendment of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a
RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the
MANUFACTURER’S RISK ASSESSMENT. Although this improved the particular standard, it still was
centered upon electrically operated hospital beds, and failed to take into account manually
operated hospital beds and products in other medical environments.
In 2000, the EN 1970 standard (Adjustable beds for DISABLED PERSONS – Requirements and
test methods) was published, which addressed beds used by DISABLED PERSONS to alleviate or
compensate for a disability or handicap. This standard offered a broadened scope in
conjunction with IEC 60601-2-38, but after the edition of Amendment 1 to IEC 60601-2-38, the
opportunity presented itself to combine the two standards to a common, international
standard.
As work began on the integration, the IEC adjusted its stance on BASIC SAFETY and ESSENTIAL
PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became
necessary to align the new standard with the third edition. The particular standard was given
a new number, IEC 60601-2-52, and work began on alignment to third edition.
This particular standard, therefore, is the realization of much work in alignment, and scope
adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It
represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL
BED as used to alleviate illness of PATIENTS and disability of DISABLED PERSONS. This is the
effort of a joint working group of the IEC and the ISO.

– 8 – 60601-2-52 © IEC:2009
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds

201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in
201.3.212.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within
the scope of this standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the General Standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.212.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 2 of this particular standard.
2)
do not apply. All other published
IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10
collateral standards in the IEC 60601-1 series apply as published.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
2)
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
60601-2-52 © IEC:2009 – 9 –
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). 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 or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

– 10 – 60601-2-52 © IEC:2009
201.2 Normative references
NOTE Informative references are listed in the bibliography on page 81.
Clause 2 of the general standard applies except as follows:
Addition:
IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough handling
shocks, primarily for equipment-type specimens
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
NOTE An index of defined terms is found beginning on page 82.
201.3.8
APPLIED PART
Addition:
The APPLIED PART includes all parts of the MEDICAL BED that are within reach of the PATIENT,
even if they are underneath the MATTRESS SUPPORT SURFACE (see Figure 201.101)
IEC  2115/09
Key
1 Region of APPLIED PART including ACCESSORIES
Figure 201.101 – APPLIED PART
201.3.76
PATIENT
Replacement:
person undergoing a medical procedure or DISABLED PERSON

60601-2-52 © IEC:2009 – 11 –
201.3.131
* TRAPPING ZONE
Addition:
locations where the body of a MEDICAL BED occupant can become entrapped, entangled,
wedged, or stuck in or between parts of the MEDICAL BED, such as the SIDE RAILS, HEAD/FOOT
BOARD, MATTRESS SUPPORT PLATFORM or mattress
Addition:
201.3.201
* APPLICATION ENVIRONMENT 1
intensive/critical care provided in a hospital where 24 h medical supervision and constant
monitoring is required and provision of life support system/equipment used in medical
procedures is essential to maintain or improve the vital functions of the PATIENT
201.3.202
* APPLICATION ENVIRONMENT 2
acute care provided in a hospital or other medical facility where medical supervision and
monitoring is required and ME EQUIPMENT used in medical procedures is often provided to help
maintain or improve the condition of the PATIENT
201.3.203
* APPLICATION ENVIRONMENT 3
long-term care in a medical area where medical supervision is required and monitoring is
provided if necessary and ME EQUIPMENT used in medical procedures may be provided to help
maintain or improve the condition of the PATIENT
NOTE This includes use in nursing homes and in rehabilitation and geriatric facilities.
201.3.204
* APPLICATION ENVIRONMENT 4
care provided in a domestic area where ME EQUIPMENT is used to alleviate or compensate for
an injury, disability or disease
NOTE This excludes use in all other APPLICATION ENVIRONMENTs (e.g. nursing homes, rehabilitation and geriatric
facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.
201.3.205
* APPLICATION ENVIRONMENT 5
outpatient (ambulatory) care, which is provided in a hospital or other medical facility, under
medical supervision where ME EQUIPMENT, is provided for the need of persons with illness,
injury or disability for treatment, diagnosis or monitoring
201.3.206
BED-LIFT
height adjustable mechanism on which a MATTRESS SUPPORT PLATFORM can be mounted
NOTE The combination of a BED LIFT and a compatible non-MEDICAL BED as specified by the MANUFACTURER is
considered to be a MEDICAL BED.
201.3.207
DISABLED PERSON
person with one or more impairments, one or more activity limitations, one or more
participation restrictions or a combination thereof
[ISO 9999:2007]
– 12 – 60601-2-52 © IEC:2009
201.3.208
HEAD/FOOT BOARD
assembly/assemblies mounted to MEDICAL BED, which identifies for the PATIENT the edge of the
head or foot end of the MEDICAL BED and/or MATTRESS SUPPORT PLATFORM
NOTE It may be used as handles to push a MEDICAL BED intended to transport PATIENTS.
201.3.209
LIFTING POLE
ACCESSORY attached to a MEDICAL BED and intended to assist support of a PATIENT when
changing position by providing a gripping support above the PATIENT
201.3.210
MATTRESS OVERLAY
supplementary mattress (support surface), which is intended to be placed on an existing
mattress, and generally used for prophylactic or therapeutic effect
201.3.211
MATTRESS SUPPORT PLATFORM
structure which supports a PATIENT surface (for example mattress)
NOTE It can articulate or change positions to facilitate various therapeutic, diagnostic and convenience positions
(See Figures 201.102 and 201.119 a) to 201.119 d)).
IEC  2116/09
Key
1 HEAD BOARD
2 Back section
3 Seat section
4 Upper leg section
5 Lower leg section
6 FOOT BOARD
Figure 201.102 – MEDICAL BED, general arrangement
(example, schematic presentation only)

60601-2-52 © IEC:2009 – 13 –
201.3.212
* MEDICAL BED
device for which the INTENDED USE is sleeping/resting that contains a MATTRESS SUPPORT
PLATFORM and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of
disease or compensation for an injury or handicap
NOTE 1 A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible non-
MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
NOTE 2 Excluded are devices for which the INTENDED USE is mainly for examination or transportation under
medical supervision (e.g. stretcher, examination table).
201.3.213
MOTION LOCKOUT CONTROL
auxiliary subsystem that deactivates motion controls
201.3.214
PENDANT CONTROL
handheld device, which has a FUNCTIONAL CONNECTION to the MEDICAL BED, controlling at least
MEDICAL BED articulations and/or movements
NOTE PENDANT CONTROLS may be wired, or wireless, and may integrate other functions, (e.g. communications,
radio/tv, etc.).
201.3.215
SIDE RAIL
physical barrier, which may be a detachable ACCESSORY or integral to the overall construction
of a MEDICAL BED and is mounted to the side(s) of the MEDICAL BED
NOTE When a SIDE RAIL is located in the “up” position it provides a physical barrier, which is intended to reduce
the RISK of the PATIENT accidentally slipping or rolling off the mattress.
201.3.216
SPECIALTY MATTRESS
mattress intended for prophylactic or therapeutic effect
201.3.217
TEST BED BOARD
flat, rigid loading board of dimensions as specified by the MANUFACTURER representing the
dimensions of the MEDICAL BED
201.3.218
UNDERCARRIAGE
all components of the MEDICAL BED or BED-LIFT below the MATTRESS SUPPORT PLATFORM
201.4 General requirements
Clause 4 of the general standard applies.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
Additional subclauses:
201.5.101 * Entrapment test tools
Figures 201.103a and 201.103b illustrate entrapment test tools (a cone tool and a cylinder
tool respectively).
– 14 – 60601-2-52 © IEC:2009
Dimensions in millimetres
228 ± 1
Market center line 115 ± 1
Surface roughness 1,6
Total weight 5,13 kg ± 0,05 kg
IEC  2117/09
Figure 201.103a – Cone tool
Dimensions in millimetres
Surface roughness 1,6 Total weight 3,34 kg ± 0,05 kg
–0,5
IEC  2118/09
Figure 201.103b – Cylinder tool
Figure 201.103 – Entrapment test tools
201.5.102 Loading pad
The loading pad (see Figure 201.104) is a rigid circular object, (355+/–5) mm in diameter, the
face of which has a convex spherical curvature of 800 mm radius with a 20 mm front edge
radius.
1 × 1 ± 0,1
∅120
–0,5
∅60
–0,5
∅60
–0,5
60601-2-52 © IEC:2009 – 15 –
IEC  2119/09
Figure 201.104 – Loading pad
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electrical shock
Addition:
For APPLICATION ENVIRONMENT 4, the MEDICAL BED shall be CLASS II.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.2 Identification
Replacement of the first paragraph:
The MEDICAL BED shall be marked with the name or trademark and address of the
MANUFACTURER, MODEL OR TYPE REFERENCE and means to allow traceability.
The detachable components shall be marked with the name or trademark and address of the
MANUFACTURER, MODEL OR TYPE REFERENCE and means to allow traceability unless mis-
identification does not present an unacceptable RISK.
Additional subclauses:
201.7.2.2.101 * Marking of maximum PATIENT weight and SAFE WORKING LOAD
The MEDICAL BED shall be marked with the corresponding maximum PATIENT weight (see
201.9.8.3.1) and SAFE WORKING LOAD (for symbol see Figure 201.105).

– 16 – 60601-2-52 © IEC:2009
IEC  2120/09
Figure 201.105 – Graphic symbol for maximum PATIENT weight
and SAFE WORKING LOAD
Detachable parts of a MEDICAL BED of a mass of more than 20 kg shall be marked with symbol
ISO 7000-1321 (2004-01): .
201.7.2.2.102 Marking for machine washable MEDICAL BEDS by an automatic washing
system
MEDICAL BEDS intended for use with an automatic washing system shall be marked with the
following text to distinguish them from MEDICAL BEDS which cannot tolerate such cleaning
methods: “Caution, for cleaning purposes this bed can be used with automatic washing
systems.”
201.7.2.2.103 Marking for MEDICAL BEDS intended for jet stream washing
MEDICAL BEDS intended for use with jet stream washing shall be marked with the following
text: “Caution, for cleaning purposes this bed can be used with jet stream washing.”
201.7.2.2.104 Width of carriage of BED-LIFT
If a BED-LIFT has an adjustable width carriage, the range shall be marked, e.g. by linear
measurement indicator fixed to the adjustable parts.
201.7.2.2.105 * Marking of replacement mattresses
MEDICAL BEDS designed to have replacement mattresses shall be marked with the following
sentence as a warning: “Incompatible mattresses can create hazards. Read instructions for
use” or a symbol as appropriate on a prominent place on the MATTRESS SUPPORT PLATFORM
indicating the compatible mattresses (see example in AA.1).
201.7.2.2.106 * Marking of detachable SIDE RAILS
MEDICAL BEDS designed to have detachable SIDE RAILS shall be marked with the following
sentence as a warning: “Incompatible SIDE RAILS can create HAZARDS. Read instructions for
use” or use a symbol as appropriate on a prominent place near the attachment point of the
SIDE RAIL, indicating the compatible SIDE RAILS (see example in AA.2).
201.7.2.4 ACCESSORIES
Addition:
Where an overload on an ACCESSORY that is intended to support loads can create an
unacceptable RISK, the corresponding SAFE WORKING LOAD shall be marked on the ACCESSORY.
Compliance is checked by inspection.
201.7.4.2 Control devices
Addition:
60601-2-52 © IEC:2009 – 17 –
Where reliance to prevent unintended movement of the MATTRESS SUPPORT PLATFORM is based
on a MOTION LOCKOUT CONTROL which requires activation by the OPERATOR, this shall be
disclosed by markings or symbols as appropriate on the outside of the MEDICAL BED and which
are visible from a position of NORMAL USE (see Figure 201.106).
NOTE Example: “Engage the MOTION LOCKOUT CONTROL if a patient could be injured due to inadvertent motion of
the MATTRESS SUPPORT PLATFORM.”
Compliance is checked by inspection of the MEDICAL BED.
201.7.6.3 Symbols for controls and performance
Addition:
Controls and/or indicators, when possible, shall be marked using symbols that convey the
intended function of those controls or indicators without the need for additional text.
NOTE Figure 201.106 is intended as a guideline when designing these symbols. In all cases where standard
international symbols exist, they should be used.
...