EN IEC 80601-2-89:2026

SLOVENSKI STANDARD
01-marec-2026
Nadomešča:
SIST EN 50637:2018
Medicinska električna oprema - 2-89. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih postelj za otroke (IEC 80601-2-89:2025)
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and
essential performance of medical beds for children (IEC 80601-2-89:2025)
Medizinische elektrische Geräte - Teil 2-89: Besondere Festlegungen für die
grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von medizinischen
Betten für Kinder (IEC 80601-2-89:2025)
Appareils électromédicaux - Partie 2-89: Exigences particulières pour la sécurité de base
et les performances essentielles des lits médicaux pour enfants (IEC 80601-2-89:2025)
Ta slovenski standard je istoveten z: EN IEC 80601-2-89:2026
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-89

NORME EUROPÉENNE
EUROPÄISCHE NORM January 2026
ICS 11.140
Supersedes EN 50637:2017
English Version
Medical electrical equipment - Part 2-89: Particular requirements
for the basic safety and essential performance of medical beds
for children
(IEC 80601-2-89:2025)
Appareils électromédicaux - Partie 2-89: Exigences Medizinische elektrische Geräte - Teil 2-89: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die grundlegende Sicherheit und die
essentielles des lits médicaux pour enfants wesentlichen Leistungsmerkmale von medizinischen Betten
(IEC 80601-2-89:2025) für Kinder
(IEC 80601-2-89:2025)
This European Standard was approved by CENELEC on 2026-01-08. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-89:2026 E

European foreword
The text of document 62D/2239/FDIS, future edition 1 of IEC 80601-2-89, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-01-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-01-31
document have to be withdrawn
This document supersedes EN 50637:2017 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN 60601-1:2006 and all of its amendments and corrigenda.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-89:2025 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
ISO 20342 (series) NOTE Approved as EN ISO 20342 (series)
IEC 61032:1997 NOTE Approved as EN 61032:1998 (not modified)
IEC 60601-2-19 NOTE Approved as EN IEC 60601-2-19
IEC 60601-1 (series) NOTE Approved as EN 60601-1-9:2008/A2 (series)
ISO 9999:2022 NOTE Approved as EN ISO 9999:2022 (not modified)
ISO 9614-1 NOTE Approved as EN ISO 9614-1
ISO 13857:2019 NOTE Approved as EN ISO 13857:2019 (not modified)
IEC 60601-1-12 NOTE Approved as EN 60601-1-12
ISO 7010:2019 NOTE Approved as EN ISO 7010:2020 (not modified)
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
ISO/IEC Guide 71:2014 NOTE Approved as CEN/CLC Guide 6:2014 (not modified)
IEC 60068-2-31 NOTE Approved as EN 60068-2-31
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 and all of its amendments and corrigenda applies, except as follows:
Addition:
Publication Year Title EN/HD Year
IEC 60529 - Degrees of protection provided by enclosures (IP - -
Code)
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
ISO 48-5 2018 Rubber, vulcanized or thermoplastic - - -
Determination of hardness – Part 5: Indentation
hardness by IRHD pocket meter method
ISO 3746 - Acoustics - Determination of sound power levels EN ISO 3746 -
and sound energy levels of noise sources using
sound pressure - Survey method using an
enveloping measurement surface over a
reflecting plane
Safety of toys - Part 3: Migration of certain EN 71-3 -
elements
Furniture - Assessment of the ignitability of EN 597-1 -
mattresses and upholstered bed bases - Part 1:
Ignition source: Smouldering cigarette

Furniture - Assessment of the ignitability of EN 597-2 -
mattresses and upholstered bed bases -Part 2:
Ignition source: Match flame equivalent

Furniture - Children's cots and folding cots for EN 716-2 -
domestic use - Part 2: Test methods

IEC 80601-2-89
Edition 1.0 2025-12
INTERNATIONAL
STANDARD
Medical electrical equipment -
Part 2-89: Particular requirements for the basic safety and essential performance
of medical beds for children
ICS 11.140  ISBN 978-2-8327-0886-6

IEC 80601-2-89: 2025-12(en)
IEC 80601-2-89:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements. 17
201.5 *General requirements for testing of ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 23
201.7 ME EQUIPMENT identification, marking and documents. 23
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 31
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 32
201.10 Protection against unwanted and excessive radiation HAZARDS . 64
201.11 Protection against excessive temperatures and other HAZARDS . 64
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 68
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 68
201.14 Programmable electrical medical systems (PEMS) . 69
201.15 Construction of ME EQUIPMENT . 69
201.16 ME SYSTEMS . 73
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 73
Annexes . 74
Annex AA (informative) Particular guidance and rationale . 75
Annex BB (normative) Additional design requirements and recommendations for
MEDICAL BEDS . 90
Annex CC (informative) Particular guidance for assessing RISK of entrapment in V-
shaped openings . 94
Annex DD (informative) Guidance and recommendations for periodic inspection . 100
Bibliography . 102
Index of defined terms . 104

Figure 201.101 – COT, general arrangement (example, schematic presentation only) . 13
Figure 201.102 – CRIB, general arrangement (example, schematic presentation only). 13
Figure 201.103 – MEDICAL BED, general arrangement (example, schematic presentation
only) . 15
Figure 201.104 – HEAD DOWN TILT, Example . 16
Figure 201.105 – FOOT DOWN TILT, Example . 17
Figure 201.106 – Small finger probe ∅ 5,6 . 18
Figure 201.107 – Entrapment test TOOLS . 20
Figure 201.108 – Loading pad . 21
Figure 201.109 – Impactor . 22
Figure 201.110 – Side impactor TOOL . 23
Figure 201.111 – Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD . 24
Figure 201.112 – Graphic symbol for mass; weight . 24
IEC 80601-2-89:2025 © IEC 2025
Figure 201.113 – Graphic symbol for machine washable MEDICAL BED . 24
Figure 201.114 – Graphic Symbol for jet stream washable MEDICAL BEDS . 25
Figure 201.115 – Graphic symbol for manual cleaning only . 25
Figure 201.116 – Description of allowed length of PATIENT . 26
Figure 201.117 – Example of marking for positioning PATIENT in MEDICAL BED . 27
Figure 201.118 – MEDICAL BED function controls and actuators: guidelines for creating
graphic symbols . 28
Figure 201.119 – Examples of marking on the MEDICAL BED of storage location for wired
and wireless PENDANT CONTROLS . 29
Figure 201.120 – Example of MEDICAL BED with segmented or split SIDE RAIL . 33
Figure 201.121 – Example of MEDICAL BED with single piece SIDE RAIL and PROTECTION
PANEL . 34
Figure 201.122 – Dimension of handle for LIFTING POLE . 39
Figure 201.123 – Allowable spacing for fingers in areas of normal reach around the
perimeter of the MATTRESS SUPPORT PLATFORM . 41
Figure 201.124 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment . 42
Figure 201.125 – Clearance areas . 43
Figure 201.126 – Required minimum radii of edges and corners . 44
Figure 201.127 – Retention of loop and mass . 45
Figure 201.128 – Lateral stability test along the side of the MEDICAL BED . 48
Figure 201.129 – Longitudinal stability test with removable FOOT BOARD . 48
Figure 201.130 – Longitudinal stability test with fixed HEAD BOARDS and FOOT BOARDS . 49
Figure 201.131 – Distribution of SAFE WORKING LOAD per maximum PATIENT weight for
tests . 53
Figure 201.132 – Position of loading pad and impactor (see Figure 201.108 for loading
pad and Figure 201.109 for impactor) . 56
Figure 201.133 – Impact to slats and solid elements of MEDICAL BEDS . 58
Figure 201.134 – Application of forces for test of SIDE RAIL . 60
Figure 201.135 – Height of PROTECTION PANELS, SIDE RAIL and PROTECTION PERIMETER . 63
Figure 201.136 – Direction of movement for rough handling test. 70
Figure 201.137 – Configurations of the MATTRESS SUPPORT PLATFORM . 71
Figure 201.138 – Small parts cylinder . 73
Figure AA.1 – Example of marking for compatible mattresses specified by the
MANUFACTURER . 77
Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the
MANUFACTURER . 77
Figure AA.3 – Resultant forces without mattress . 80
Figure AA.4 – Resultant forces with mattress . 80
Figure AA.5 – 40 mm gap measurement of B . 80
Figure AA.6 – Angle measurement example of B . 80
Figure AA.7 – Placement of a measurement TOOL for the measurement of D . 81
X
Figure AA.8 – Example of area D measurement that passes . 82
X
Figure AA.9 – Example of area D measurement that fails (on limit) . 82
X
Figure AA.10 – Example of area D measurement that fails. 82
X
IEC 80601-2-89:2025 © IEC 2025
Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL. 83
Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 83
Figure AA.13 – Example of potential PATIENT entrapment in area B . 83
Figure AA.14 – Example of potential PATIENT entrapment in area C between segmented
or split SIDE RAIL . 83
Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL
and HEAD BOARD . 83
Figure AA.16 – Example of potential PATIENT entrapment in area D . 83
Figure AA.17 – Example of potential PATIENT entrapment in area A below a single
piece SIDE RAIL . 84
Figure BB.1 – Schematic presentation of under MEDICAL BED clearance . 92
Figure BB.2 – Angles for different sections of the MATTRESS SUPPORT PLATFORM . 93
Figure CC.1 – Wedge TOOL. 95
Figure CC.2 – V-shaped opening in relation to B. 96
Figure CC.3 – Acceptance criteria in relation to area B . 96
Figure CC.4 – Positioning of wedge TOOL . 97
Figure CC.5 – Acceptance criteria in relation to area C between HEAD BOARD and FOOT
BOARD . 98
Figure CC.6 – Acceptance criteria in relation to area C between segmented or split
SIDE RAILS . 99

Table 201.101 – Protection against PATIENT entrapment . 35
Table 201.102 – Minimum SAFE WORKING LOADS . 52
Table 201.103 – Protection against inadvertent PATIENT falls and climbing out of
MEDICAL BED . 63
Table 201.104 – Allowable maximum temperatures for skin contact with MEDICAL BED
APPLIED PARTS . 64
Table 201.105 – Machine washable compliance PROCEDURE . 66
Table AA.1 – Protection against PATIENT entrapment in non-moving parts. 79
Table AA.2 – Height of protective barriers according to age . 88

IEC 80601-2-89:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical electrical equipment -
Part 2-89: Particular requirements for the basic safety
and essential performance of medical beds for children

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
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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
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 80601-2-89 has been prepared by a Joint Working Group of IEC subcommittee 62D:
Particular medical equipment, software, and systems, of IEC technical committee 62: Medical
equipment, software, and systems, and ISO technical committee 173: Assistive products. It is
an International Standard.
This publication is published as a double logo standard.
IEC 80601-2-89:2025 © IEC 2025
The text of this International Standard is based on the following documents of IEC:
Draft Report on voting
62D/2239/FDIS 62D/2272/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table. In ISO, the document was approved by XXX P members out of YYY having
cast a vote.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, 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 document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "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 80601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
IEC 80601-2-89:2025 © IEC 2025
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
IEC 80601-2-89:2025 © IEC 2025
INTRODUCTION
IEC 80601-2-52[1] applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS
for ADULTS, hence not covering requirement for beds for CHILDREN and ADULTS with atypical
anatomy. This particular standard is based on EN 50637[2], which was created pursuant to
Mandate M/467 Medical beds issued by the European Commission with the following
background information:
It appears, from a first analysis undertaken by EU Competent Authorities, that the current set
of standards is not adapted to the needs of CHILDREN or ADULTS with an atypical anatomy.
IEC 80601-2-52 does not foresee a maximum distance for the bars that is small enough to
prevent accidents.
According to the EU Competent Authorities' representatives, a part of the safety problem is due
to the fact that MEDICAL BEDS for ADULTS are not appropriately labelled as being designed only
for ADULTS with a normal anatomy. Users are therefore not always aware of the risk of MEDICAL
BEDS for young PATIENTS or for ADULTS with an atypical anatomy. Hospital administrations do
not always see a need to buy MEDICAL BEDS which are appropriate for CHILDREN or for ADULTS
with an atypical anatomy. Therefore, clear labelling of the targeted PATIENT groups for MEDICAL
BEDS complying with IEC 80601-2-52 could reduce the risk of inappropriate use of this kind of
MEDICAL BEDS for CHILDREN or for ADULTS with an atypical anatomy.
EU Competent Authorities' representatives also stated that there is a need for the development
of requirements for MEDICAL BEDS and COTS for CHILDREN and ADULTS with an atypical anatomy.
In order to prevent IEC 80601-2-52 from being extraordinarily complex to use, TC 62 decided
to develop this particular standard rather than further amending IEC 80601-2-52 in relation to
use for CHILDREN and ADULTS with an atypical anatomy.
This standard is based on EN 50637 and IEC 80601-2-52 with input from the following
standards and reports:
• EN 716-1, Furniture – V Children's cots and folding cots for domestic use – Part 1: Safety
requirements
• EN 716-2, Furniture – Children's cots and folding cots for domestic use – Part 2: Test
methods
• EN 1130, Furniture – Children's furniture – Cribs – Safety requirements and test methods
• EN 747-1, Furniture – Bunk beds and high beds – Part 1: Safety, strength and durability
requirements
• EN 747-2, Furniture – Bunk beds and high beds – Part 2: Test methods
• CEN/TR 13387 (all parts), Child use and care articles – General safety guidelines
• DIN 32623, Hospital children's cots made from metal and plastic – Safety requirements and
testing
• Nordic Requirements specification for Adjustable beds for disabled children

___________
Numbers in square brackets refer to the Bibliography.
IEC 80601-2-89:2025 © IEC 2025
201.1 Scope, object and related standards
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 1, applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL
BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as
defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition
for ADULTS in 201.3.201).
This document applies to both electrical and non-electrical (manual) MEDICAL BEDS with or
without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH
of up to 180 cm suitable to a body length of 155 cm.
NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with
the CHILD or that the bed will be used by an ADULT.
If a MANUFACTURER wishes to make a MEDICAL BED that can be used by both a CHILD and an
ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply.
This document does not apply to:
• ADULT only MEDICAL BEDS covered by IEC 80601-2-52;
• SPECIALITY MATTRESS covered by the ISO 20342 series[5];
• incubators covered by IEC 60601-2-19;
• devices for which the INTENDED USE is mainly for examination or transportation under
medical supervision (e.g. stretcher, examination table).
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 BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document except
in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 4.2.
NOTE 3 Whenever the term MEDICAL ELECTRICAL EQUIPMENT (MEE, ME Equipment) is used within the series
of IEC 60601 standards, it refers to MEDICAL BEDS, both electrical and non-electrical.
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements and test methods for MEDICAL BEDS as defined in 201.3.219 intended for CHILDREN
as defined in 201.3.207 and ADULTS with atypical anatomy, i.e. ADULTS ranging outside the
definition for ADULTS in 202.3.201.
IEC 80601-2-89:2025 © IEC 2025
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in the
IEC 60601-1 series apply as published.
NOTE Some IEC 60601-1-8 requirements can be excluded if they do not affect PATIENT safety, could lead to user
confusion, or are inappropriate to MEDICAL BED usage.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, including the collateral standards as appropriate for the
particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCe requirements.
Requirements of this document takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this particular standard corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2:2015 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3:2008 collateral standard, etc.). The changes to the text of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
IEC 80601-2-89:2025 © IEC 2025
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.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard, although possibly relevant, is not to be applied, a statement to that effect is given in
this document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 Informative references are listed in the Bibliography.
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 2, applies except as follows:
Addition:
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
ISO 48-5:2018, Rubber, vulcanized or thermoplastic - Determination of hardness - Part 5:
Indentation hardness by IRHD pocket meter method
ISO 3746, Acoustics - Determination of sound power levels of noise sources using sound
pressure - Survey method using an enveloping measurement surface over a reflecting plane
EN 71-3, Safety of toys - Part 3: Migration of certain elements
EN 597-1, Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -
Part 1: Ignition source : Smouldering cigarette
EN 597-2, Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -
Part 2: Ignition source: Match flame equivalent
EN 716-2, Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
IEC 80601-2-89:2025 © IEC 2025
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
– IEC Electropedia: available at https://www.electropedia.org/
– ISO Online browsing platform: available at https://www.iso.org/obp
NOTE An index of defined terms is given after the Bibliography.
201.3.76
PATIENT
Replacement:
living person undergoing a medical PROCEDURE or PERSON WITH DISABILITY
Note 1 to entry: Whenever the term PATIENT is used, it comprises both ADULTS with an atypical anatomy and
CHILDREN.
201.3.109
SAFE WORKING LOAD
SWL
Replacement:
sum of:
1) the PATIENT;
2) the mattress;
3) the ACCESSORIES of the MEDICAL BED, only if they are supported by the support system of the
MEDICAL BED; and
4) the SAFE WORKING LOADS supported by those ACCESSORIES, excluding PATIENT weight
201.3.131
* TRAPPING ZONE
Replacement:
locations where the PATIENT or other persons 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
Additional terms and definitions:
201.3.201
ADULT
PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than 40
kg and a body mass index (BMI) equal to or more than 17
201.3.202
APPLICATION ENVIRONMENT 1
*
intensive care or critical care provided in a hospital where 24 h medical supervision and
constant monitoring is required and provision of life support equipment used in medical
PROCEDURES is essential to maintain or improve the vital functions of the PATIENT
IEC 80601-2-89:2025 © IEC 2025
201.3.203
* APPLICATION ENVIRONMENT 2
acute care provided in a hospital or other medical facility where medical supervision and
monitoring is required and MEDICAL BED used in medical PROCEDURES is often provided to help
maintain or improve the condition of the PATIENT
201.3.204
* APPLICATION ENVIRONMENT 3
long-term care in a medical area where medical supervision is required and monitoring is
provided if necessary and MEDICAL BED used in medical PROCEDURES may be provided to help
maintain or improve the condition of the PATIENT
Note 1 to entry: This includes use in CHILDREN'S nursing homes and in rehabilitation facilities.
201.3.205
* APPLICATION ENVIRONMENT 4
care provided in a domestic area where MEDICAL BED is used to alleviate or compensate for an
injury, disability or disease
Note 1 to entry: This excludes use in all other application environments (e.g. CHILDREN'S nursing homes and
rehabilitation facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.
201.3.206
* APPLICATION ENVIRONMENT 5
outpatient care or ambulatory care, which is provided in a hospital or other medical facility,
under medical supervision where MEDICAL BED, is provided for the need of persons with illness,
injury or disability for treatment, diagnosis or monitoring
201.3.207
CHILD
PATIENT having a body length equal to or less than 155 cm and a mass equal to or less than
70 kg and may display cognitive immaturity, exploratory behaviours, risk taking tendencies or
any combination.
Note 1 to entry: Body length is measured from crown to sole.
201.3.208
COT
MEDICAL BED with an INTERNAL LENGTH ≥90 cm and <140 cm provided with PROTECTION PANELS
also intended for CHILDREN able to stand up in bed
Note 1 to entry: See Figure 201.101.
IEC 80601-2-89:2025 © IEC 2025

Figure 201.101 – COT, general arrangement
(example, schematic presentation only)
201.3.209
CRIB
MEDICAL BED with an INTERNAL LENGTH <90 cm provided with PROTECTION PERIMETER, intended
for CHILDREN until they are able to sit, kneel or to pull themselves up
Note 1 to entry: See Figure 201.102.
Note 2 to entry: Excluded are MEDICAL BEDS with a swinging or rocking function.
Dimensions in millimetres
Figure 201.102 – CRIB, general arrangement
(example, schematic presentation only)
201.3.210
PERSON WITH DISABILITY
person with one or more impairments, one or more activity limitations, one or more participation
restrictions or a combination thereof
[SOURCE: ISO 9999:2022, 3.10]
IEC 80601-2-89:2025 © IEC 2025
201.3.211
HEAD OR FOOT BOARD
assembly mounted to MEDICAL BED, which identifies for the PATIENT the edge of the head or foot
end of the MEDICAL BED or MATTRESS SUPPORT PLATFORM
Note 1 to entry: It can be used as handles to push a MEDICAL BED intended t
...