IEC 60601-2-52:2009

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

IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. 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. IEC 60601-2-52:2009 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.

Appareils électromédicaux — Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des lits médicaux

La CEI 60601-2-52:2009 s'applique à la sécurité de base et aux performances essentielles des lits medicaux destinés aux adultes. Cette première édition annule et remplace la première édition de la CEI 60601-2-38, parue en 1996, et son Amendement (1999). Elle constitue une révision technique. La CEI 60601-2-52:2009 est la réalisation d'un travail important d'alignement et d'ajustement de domaines d'application entre la CEI 60601-2-38, la EN 1970, et la troisième édition de la CEI 60601-1.

General Information

• Status: Published
• Publication Date: 13-Dec-2009
• ICS: 11.140 - Hospital equipment
• Technical Committee: ISO/TC 173 - Assistive products
• Drafting Committee: ISO/TC 173 - Assistive products
• Current Stage: 9092 - International Standard to be revised
• Start Date: 25-Sep-2020
• Completion Date: 25-Sep-2020

Relations

• Amended By: IEC 60601-2-52:2009/Amd 1:2015 - Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Amendment 1
• Effective Date: 07-Aug-2021

Standards Content (Sample)

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

IEC 60601-2-52:2009

---------------------- Page: 1 ----------------------
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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

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– 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
12
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

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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

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– 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

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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
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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

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– 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.

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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.

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– 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

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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
...