IEC/FDIS 80601-2-52

FINAL DRAFT
International
Standard
IEC/FDIS
80601-2-52
ISO/TC 173
Medical electrical equipment —
Secretariat: SIS
Part 2-52:
Voting begins on:
2025-11-07
Particular requirements for
the basic safety and essential
Voting terminates on:
2026-01-02
performance of medical beds
Appareils électromédicaux —
Partie 2-52: Exigences particulières de sécurité de base et de
performances essentielles des lits médicaux
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
IEC/FDIS
80601-2-52
ISO/TC 173
Medical electrical equipment —
Secretariat: SIS
Part 2-52:
Voting begins on:
Particular requirements for 2025-11-07
the basic safety and essential
Voting terminates on:
2026-01-02
performance of medical beds
Appareils électromédicaux —
Partie 2-52: Exigences particulières de sécurité de base et de
performances essentielles des lits médicaux
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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ii
IEC FDIS 80601-2-52 © 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 . 16
201.5 General requirements for testing of ME EQUIPMENT. 17
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 20
201.7 ME EQUIPMENT identification, marking and documents . 20
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 26
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 27
201.10 Protection against unwanted and excessive radiation HAZARDS . 54
201.11 Protection against excessive temperatures and other HAZARDS . 54
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 58
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 59
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 59
201.15 Construction of ME EQUIPMENT . 59
201.16 ME SYSTEMS . 64
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 64
Annexes . 65
Annex AA (informative) Particular guidance and rationale . 66
Annex BB (normative) Additional design requirements and recommendations for
MEDICAL BEDS . 86
Annex CC (informative) Particular guidance for assessing RISK of entrapment in V-
shaped openings . 91
Annex DD (informative) Guidance and recommendations for periodic inspection . 97
Bibliography . 99
Index of defined terms . 100

Figure 201.101 – MEDICAL BED, general arrangement (example, schematic presentation
only) . 14
Figure 201.102 – HEAD DOWN TILT, Example . 15
Figure 201.103 – FOOT DOWN TILT, Example . 16
Figure 201.104 – Entrapment test tools. 18
Figure 201.105 – Loading pad . 19
Figure 201.106 – Impactor . 19
Figure 201.107 – Ball chain loop and spherical mass . 20
Figure 201.108 – Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD . 21
Figure 201.109 – Graphic symbol for mass; weight . 21
Figure 201.110 – Graphic symbol for machine washable MEDICAL BED . 21
Figure 201.111 – Graphic symbol for jet stream washable MEDICAL BED. 22
IEC FDIS 80601-2-52 © IEC 2025
Figure 201.112 – Graphic symbol for manual cleaning only . 22
Figure 201.113 – Physical description of PATIENT . 23
Figure 201.114 – MEDICAL BED function controls or actuators or both: guidelines for
creating graphic symbols . 24
Figure 201.115 – Example of MEDICAL BED with segmented or split SIDE RAIL . 28
Figure 201.116 – Example of MEDICAL BED with single piece SIDE RAIL . 29
Figure 201.117 – Allowable spacing for fingers in areas of normal reach around the
perimeter of the MATTRESS SUPPORT PLATFORM . 34
Figure 201.118 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT finger entrapment . 35
Figure 201.119 – Clearance areas . 36
Figure 201.120 – Retention of loop and mass . 38
Figure 201.121 – Lateral stability test along the side of the MEDICAL BED . 40
Figure 201.122 – Longitudinal stability test with removable FOOT BOARD . 41
Figure 201.123 – Longitudinal stability test with fixed HEAD BOARD and FOOT BOARD . 41
Figure 201.124 – Distribution of SAFE WORKING LOAD / maximum PATIENT weight for tests . 45
Figure 201.125 – Positions of dynamic loading (see Figure 201.103 for loading pad
and Figure 201.104 for impactor) . 48
Figure 201.126 – Application of forces for test of SIDE RAIL. 50
Figure 201.127 – Height of SIDE RAIL . 53
Figure 201.128 – Direction of movement for rough handling test . 60
Figure 201.129 – Configurations of the MATTRESS SUPPORT PLATFORM . 62
Figure AA.1 – Example of marking to select recommended mattresses specified by the
MANUFACTURER . 69
Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the
MANUFACTURER . 69
Figure AA.3 – Examples of marking on the MEDICAL BED of storage location for wired
and wireless PENDANT CONTROLS . 70
Figure AA.4 – Resultant forces without mattress . 73
Figure AA.5 – Resultant forces with mattress . 74
Figure AA.6 – Example of 60 mm gap measurement of B . 74
Figure AA.7 – Angle measurement example of B . 75
Figure AA.8 – Placement of measurement tool for measurement of D . 75
Figure AA.9 – Example of area D measurement that passes . 76
Figure AA.10 – Example of area D measurement that fails (on limit) . 76
Figure AA.11 – Example of area D measurement that fails . 77
Figure AA.12 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 77
Figure AA.13 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 77
Figure AA.14 – Example of potential PATIENT entrapment in area B . 78
Figure AA.15 – Example of potential PATIENT entrapment in area C between split
SIDE RAIL . 78
Figure AA.16 – Example of potential PATIENT entrapment in area C between SIDE RAIL
and HEAD BOARD . 78
Figure AA.17 – Example of potential PATIENT entrapment in area D . 78
Figure AA.18 – Example of potential PATIENT entrapment in area A below a single
piece SIDE RAIL . 79
IEC FDIS 80601-2-52 © IEC 2025
Figure AA.19 – Concept of potential PATIENT foot-first entrapment tool for area A below
a SIDE RAIL . 80
Figure BB.1 – Schematic presentation of under MEDICAL BED clearance. 88
Figure BB.2 – Recommendations and requirements regarding angles for different
sections of the MATTRESS SUPPORT PLATFORM . 90
Figure CC.1 – Wedge tool . 92
Figure CC.2 – V-shaped opening in relation to B. 93
Figure CC.3 – Acceptance criteria in relation to area B . 94
Figure CC.4 – Positioning of wedge tool . 95
Figure CC.5 – Acceptance criteria in relation to area C between HEAD BOARD and FOOT
BOARD . 95
Figure CC.6 – Acceptance criteria in relation to area C between split SIDE RAILS . 96

Table 201.101 – Protection against PATIENT entrapment . 30
Table 201.102 – Minimum SAFE WORKING LOADS . 44
Table 201.103 – Protection against inadvertent PATIENT falls . 54
Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED
PARTS . 55
Table 201.104 – Machine washable compliance PROCEDURE . 57

IEC FDIS 80601-2-52 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical electrical equipment -
Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds for adults

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,
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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
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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
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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 and ISO draw attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC and ISO take 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 and ISO 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 and ISO shall not be held responsible for identifying any or all such patent rights.
IEC 80601-2-52 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.
It is published as double logo standard.
IEC FDIS 80601-2-52 © IEC 2025
The text of this International Standard is based on the following documents of IEC:
Draft Report on voting
62D/XX/FDIS 62D/XX/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 standard has been 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 document, 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 particular standard 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 FDIS 80601-2-52 © 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 FDIS 80601-2-52 © IEC 2025
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 PERSONS WITH DISABILITY 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 published in 2005. 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 IEC 60601-1:2005. 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 PERSONS WITH DISABILITY. This is the effort of a joint
working group of the IEC and the ISO.
IEC 80601-2-52 is a continuation of the IEC 60601-2-52 standard. It will align with the CHILDREN
version of the standard, IEC 80601-2-89. The standard number was changed from
IEC 60601-2-52 to IEC 80601-2-52 to indicate joint work between the ISO and the IEC.

IEC FDIS 80601-2-52 © 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 as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the
scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable
functions.
This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM
or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a
compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL
BED.
This document does not apply to:
• MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside
the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89[1] ;
• SPECIALITY MATTRESS covered by ISO 20342 series[2];
• devices for which the INTENDED USE is mainly for examination or transportation under
medical supervision (e.g. stretcher, examination table);
• all requirements for MEDICAL BEDS with special functionality.
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 document are not covered by specific requirements in this document except
in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020.
NOTE 1 See also 4.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
NOTE 2 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 for MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in
201.3.222.
___________
Numbers in square brackets refer to the Bibliography.
IEC FDIS 80601-2-52 © 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 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
Addition:
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.
A requirement of a particular standard 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 collateral standard, 203.4 in this document addresses the content of Clause
4 of the IEC 60601-1-3 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 FDIS 80601-2-52 © 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:
Replacement:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Addition:
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 3746, Acoustics - Determination of sound power levels and sound energy levels of noise
sources using sound pressure - Survey method using an enveloping measurement surface over
a reflecting plane
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
IEC FDIS 80601-2-52 © 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
201.3.8
APPLIED PART
Addition:
Note 4 to entry: The APPLIED PART includes all parts of the MEDICAL BED that are within the reach of the PATIENT
even if they are underneath the MATTRESS SUPPORT PLATFORM.
201.3.76
PATIENT
Replacement:
living person undergoing a medical PROCEDURE or PERSON WITH DISABILITY
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:
location 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 BOARD, FOOT BOARD,
MATTRESS SUPPORT PLATFORM or mattress
Additional terms and definitions:
201.3.201
* 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 FDIS 80601-2-52 © IEC 2025
201.3.202
* 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
201.3.203
* 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 nursing homes and in rehabilitation and geriatric facilities.
201.3.204
* 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. nursing homes, rehabilitation and
geriatric facilities) when a MEDICAL BED is purely designed for APPLICATION ENVIRONMENT 4.
201.3.205
* 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
201.3.206
* APPLICATION ENVIRONMENT 6
psychiatric care or mental health care environment where medical supervision is required, and
monitoring is provided. MEDICAL BED used in medical PROCEDURES may be provided to help
maintain, improve condition and protect the PATIENT
Note 1 to entry: Environment where a patient may be a harm to themselves or others.
Note 2 to entry: Includes prisons, jails, correctional facilities.
201.3.207
BED-LIFT
height adjustable mechanism on which a MATTRESS SUPPORT PLATFORM can be mounted
Note 1 to entry: The combination of a BED LIFT and a compatible non-MEDICAL BED as specified by the MANUFACTURER
is considered to be a MEDICAL BED.
201.3.208
CHILD
PATIENT having a physical size 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: Physical size is measured from crown to sole.
[SOURCE: IEC 80601-2-89:2025[1], 201.3.207, modified – “Body length” replaced with
“physical size” in the definition and in Note 1 to entry.]
IEC FDIS 80601-2-52 © IEC 2025
201.3.209
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], 3.10]
201.3.210
HEAD OR FOOT BOARD
assembly mounted to a MEDICAL BED, which identifies for the PATIENT the edge of the head or
foot end of either the MEDICAL BED or MATTRESS SUPPORT PLATFORM or both
Note 1 to entry: It can be used as handles to push a MEDICAL BED intended to transport PATIENTS.
201.3.211
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
201.3.212
MATTRESS OVERLAY
supplementary mattress, which is intended to be placed on an existing mattress, and generally
used for prophylactic or therapeutic effect
201.3.213
MATTRESS SUPPORT PLATFORM
structure which supports a PATIENT surface
Note 1 to entry: The platform can articulate or change positions to facilitate various therapeutic, diagnostic and
convenience positions (See Figure 201.101).
IEC FDIS 80601-2-52 © IEC 2025

Key
1 HEAD BOARD
2 Back section (part of MATTRESS SUPPORT PLATFORM)
3 Seat section (part of MATTRESS SUPPORT PLATFORM)
4 Upper leg section (part of MATTRESS SUPPORT PLATFORM)
5 Lower leg section (part of MATTRESS SUPPORT PLATFORM)
6 FOOT BOARD
Figure 201.101 – MEDICAL BED, general arrangement
(example, schematic presentation only)
201.3.214
* MEDICAL BED
device for which the INTENDED USE is sleeping, resting or both that contains a MATTRESS SUPPORT
PLATFORM and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of
disease or compensation for an injury or disability
201.3.215
MOTION LOCKOUT CONTROL
auxiliary subsystem that deactivates motion controls
201.3.216
PENDANT CONTROL
handheld device, which has a FUNCTIONAL CONNECTION to the MEDICAL BED, controlling at least
MEDICAL BED articulations or movements or both.
Note 1 to entry: PENDANT CONTROLS can be wired, or wireless, and can integrate other functions such as
communications, radio, tv, etc.
201.3.217
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 1 to entry: 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.
IEC FDIS 80601-2-52 © IEC 2025
201.3.218
SPECIALTY MATTRESS
mattress intended for prophylactic or therapeutic effect
201.3.219
TEST BED BOARD
flat, rigid loading board of dimensions as specified by the MANUFACTURER representing the
dimensions of the MEDICAL BED
201.3.220
TRENDELENBURG
specific therapeutic position used in some medical PROCEDURES requiring a minimum 12° head
down angle of the entire MATTRESS SUPPORT PLATFORM with respect to horizontal
201.3.221
UNDERCARRIAGE
all components of the MEDICAL BED or BED-LIFT below the MATTRESS SUPPORT PLATFORM
201.3.222
* 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
201.3.223
HEAD DOWN TILT
entire MATTRESS SUPPORT PLATFORM positioned in a head down angle less than 12° with respect
to horizontal
Key
1 HEAD BOARD
2 FOOT BOARD
3 MATTRESS SUPPORT PLATFORM
Figure 201.102 – HEAD DOWN TILT, Example
201.3.224
FOOT DOWN TILT
entire MATTRESS SUPPORT PLATFORM positioned in any foot down angle with respect to horizontal
IEC FDIS 80601-2-52 © IEC 2025

Key
1 HEAD BOARD
2 FOOT BOARD
3 MATTRESS SUPPORT PLATFORM
Figure 201.103 – FOOT DOWN TILT, Example
201.4 General requirements
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 4 applies, except as follows:
201.4.2.2 * General requirement for RISK MANAGEMENT
Addition:
The MANUFACTURER shall include, in the RISK MANAGEMENT PROCESS, HAZARDS (e.g. entrapment,
PATIENT falls) related to PATIENTS taller than 185 cm, or having a physical size, mass and body
mass index (BMI) outside the definition of ADULT.
Bariatric PATIENT population shall also be considered in the RISK MANAGEMENT PROCESS.
Alternative means not described in this document to ensure an equivalent level of BASIC SAFETY
and ESSENTIAL PERFORMANCE shall be justified by the MANUFACTURER in the RISK MANAGEMENT
FILE.
The ACCOMPANYING DOCUMENT shall document any HAZARDS associated with this use case
For MEDICAL BEDS intended for APPLICATION ENVIRONMENT 6, the RISK MANAGEMENT shall include:

– strangulation HAZARDS;
– snagging HAZARDS;
– disassembly resulting in choking, ingestion or both;
– material flammability.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Addition:
All parts within the reach of the PATIENT, even if they are underneath the MATTRESS SUPPORT
PLATFORM (see Figure 201.118) shall be included in the RISK MANAGEMENT PROCESS for
determination if they should be treated as APPLIED PARTS.
For APPLICATION ENVIRONMENT 4 and APPLICATION ENVIRONMENT 6, all ACCESSIBLE PARTS shall be
treated as APPLIED PARTS (the entire bed).
IEC FDIS 80601-2-52 © IEC 2025
201.5 General requirements for testing of ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 5 applies, except as follows:
201.5.9.2 ACCESSIBLE PARTS
Addition:
NOTE For APPLICATION ENVIRONMENT 6, accessibility of parts considers the use of specialty or safety fasteners and
robustness of ENCLOSURE material to prevent access or removal of parts (see 201.15.4.104).
Additional subclauses:
201.5.101 * Entrapment test tools
Figure 201.104 a) and b) illustrate entrapment test TOOLS (a cone TOOL and a cylinder TOOL
respectively).
IEC FDIS 80601-2-52 © IEC 2025
Dimensions in millimeters
Total weight 5,13 kg ±0,05 kg
Key
1 Marked centre line
2 Drilling hole for weight adjustment, if necessary
3 The surface roughness of the TOOL is less than or equal to 1,6 µm
a) Cone tool schematic
Dimensions in millimeters
Total weight 3,34 kg ±0,05 kg
Key
1 Drilling hole for weight adjustment, if necessary
2 The surface roughness of the TOOL is less than or equal to 1,6 µm
b) Cylinder tool schematic
Figure 201.104 – Entrapment test tools
201.5.102 Loading pad
The loading pad (see Figure 201.105) is a rigid circular object, 355 ± 5 mm in diameter, the
face of which has a convex spherical curvature of 800 mm radius ± 5 mm(R800) with a 20 ±
5 mm (R20) front edge radius.
IEC FDIS 80601-2-52 © IEC 2025
Dimensions in millimeters
Figure 201.105 – Loading pad
201.5.103 *Impactor
The impactor body is 200 ± 5 mm in diameter and is mounted to the striking surface. The total
mass of the assembly shall be 25 kg ± 0,1 kg.
The striking surface shall be a rigid circular object, 200 ± 5 mm in diameter, the face of which
has a convex spherical curvature of 300 ± 5 mm radius (R300) with a 12 ± 5 mm (R12) front
edge radius.
Key
1 Connecting part of the lifting device which shall not restrain the free fall
2 Striking surface
Figure 201.106 – Impactor
IEC FDIS 80601-2-52 © IEC 2025
Dimensions in millimeters
Key
1 Ball chain loop with a length of 200 ± 2 mm
2 Spherical mass, weight 2,5 ± 0,05 kg and diameter 115 ± 1 mm
3 Fixing point
NOTE The ball chain loop is formed by the ball chain entering the spherical mass at a common fixin
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