IEC 60601-2-21:2020
(Main)Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés
L'IEC 60601-2-21:2020 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des INCUBATEURS RADIANTS POUR NOUVEAU-NES, tels que définis au 201.3.204, également désignés sous le terme APPAREILS EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et de 8.4.1 de la norme générale. L'IEC 60601-2-21:2020 spécifie les exigences de sécurité relatives aux INCUBATEURS RADIANTS POUR NOUVEAU-NES, mais des méthodes alternatives de conformité à un article spécifique, en démontrant un niveau équivalent de sécurité, ne sont pas considérées comme non conformes, si le FABRICANT a démontré dans son DOSSIER DE GESTION DES RISQUES que le RISQUE présenté par le DANGER s’est révélé avoir un niveau acceptable, lorsqu’il a été évalué par rapport aux avantages du traitement présentés par le dispositif.
La présente norme particulière ne s'applique pas aux:
- dispositifs délivrant de la chaleur par l'intermédiaire de COUVERTURES, COUSSINS ou MATELAS en usage médical; voir l’IEC 60601-2-35 à titre informatif;
- INCUBATEURS POUR NOUVEAU-NES, voir l’IEC 60601-2-19 à titre informatif;
- INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES; voir l’IEC 60601-2-20 à titre informatif;
- APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU-NES, voir l’IEC 60601-2-50 à titre informatif.
Les CAPTEURS DE TEMPERATURE CUTANEE appliqués au fonctionnement d’un INCUBATEUR RADIANT A REGULATION CUTANEE incluant la valeur affichée ne sont pas considérés comme un THERMOMETRE MEDICAL au sens de la norme particulière ISO 80601-2-56. L'IEC 60601-2-21:2020 annule et remplace la deuxième édition parue en 2009 et son Amendement 1 (2016). Cette édition constitue une révision technique. Cette édition inclut la modification technique majeure suivante par rapport à l'édition précédente: alignement avec l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.
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STANDARD
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Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
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IEC 60601-2-21 ®
Edition 3.0 2020-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.10 ISBN 978-2-8322-8922-8
– 2 – IEC 60601-2-21:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 2
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests .
210 Requirements for the development of physiologic closed-loop controllers .
202 Electromagnetic disturbances – Requirements and tests . 23
Annexes . 26
Annex AA (informative) Particular guidance and rationale . 27
Bibliography . 36
Index of defined terms used in this document . 39
Figure 201.101 – Layout of TEST DEVICES . 10
Figure 201.102 – TEST DEVICE . 11
Figure AA.1 – Illustration of the main requirements of this document . 27
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
FOREWORD
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This redline version of the official IEC Standard allows the user to identify the changes
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– 4 – IEC 60601-2-21:2020 RLV © IEC 2020
International standard IEC 60601-2-21 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
The text of this international standard is based on the following documents:
FDIS Report on voting
62D/1766/FDIS 62D/1776/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD 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 standard 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 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 document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-21:2020 RLV © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT RADIANT WARMER equipment.
This particular standard amends and supplements IEC 60601-1:2005, Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance,
hereinafter referred to as the "general standard".
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate
the proper application of this particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, Annex AA does not form part of the requirements of this document.
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but
alternate methods of compliance with a specific clause, by demonstrating equivalent safety,
will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
• devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 80601-2-35 IEC 60601-2-35;
• INFANT INCUBATORS; for information, see IEC 60601-2-19;
• INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
• INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
_______________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
– 8 – IEC 60601-2-21:2020 RLV © IEC 2020
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204, which
minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with
the requirements can be verified.
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.
IEC 60601-1-2:2014 and IEC 60601-1-10 applies as modified in Clauses 202 and 210
respectively. 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.
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
under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
EQUIPMENT
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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 and
applicable collateral standards 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
147, additional definitions in this document are
standard are numbered 3.1 through 3.139 3.
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 document" 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.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
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
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard
apply, except as follows:
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
– 10 – IEC 60601-2-21:2020 RLV © IEC 2020
NOTE An index of defined terms is found beginning on page 35.
Addition:
201.3.201
BABY CONTROLLED RADIANT WARMER
mode of operation in which the power output varies automatically in order to maintain the
temperature as measured by a SKIN TEMPERATURE SENSOR according to the CONTROL
TEMPERATURE set by the OPERATOR
NOTE An INFANT RADIANT WARMER operating as a BABY CONTROLLED RADIANT WARMER is a PHYSIOLOGIC CLOSED-
LOOP CONTROLLER as defined in IEC 60601-1-10.
201.3.202
CONTROL TEMPERATURE
temperature selected at the temperature control
201.3.203
INFANT
PATIENT up to 3 months and with a weight of less than 10 kg
201.3.204
INFANT RADIANT WARMER
electrically powered device with a radiant heating source intended to maintain the thermal
balance of an INFANT by direct radiation of energy in the infrared region of the electromagnetic
spectrum
201.3.205
MANUAL MODE
mode of operation in which the heater output is either at a fixed level or a proportion of its
maximum output set by the OPERATOR
201.3.206
MID-POINT AVERAGE TEMPERATURE
T
M
TEST DEVICE AVERAGE TEMPERATURE of the TEST DEVICE positioned at the mid-point of the
INFANT RADIANT WARMER MATTRESS (see Figure 201.101)
Key
1 = Mattress
Figure 201.101 – Layout of TEST DEVICES
201.3.207
*
PREWARM MODE
mode of operation in which the heater output is maintained at a preset level (set by the
MANUFACTURER) for the purpose of pre-warming the INFANT RADIANT WARMER and maintaining
the level of warmth of the INFANT RADIANT WARMER prior to an INFANT being placed on the
device
201.3.208
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT’s SKIN TEMPERATURE
201.3.209
STEADY TEMPERATURE CONDITION
TEST DEVICE
condition which is reached when the temperature, measured at the centre of the
positioned on the mid-point of the INFANT RADIANT WARMER MATTRESS, does not vary by more
than 1 °C over a period of 1 h
201.3.210
TEST DEVICE
totally matt blackened disc used as a reproducible receiver of radiant energy during testing of
INFANT RADIANT WARMER (see Figure 201.102)
the
Dimensions in millimetres
Key
1 = Mattress
Surface finish: non-reflective black paint
Disc mass: 500 g ± 10 g
3 3
Disc material: aluminium of density within the range 2,6 g/cm and 2,9 g/cm
Figure 201.102 – TEST DEVICE
201.3.211
TEST DEVICE AVERAGE TEMPERATURE
(T , T , T , T OR T )
1 2 3 4 M
AVERAGE TEMPERATURE reading taken during a STEADY TEMPERATURE CONDITION at regular
intervals at the centre of a TEST DEVICE
Note 1 to entry: T , T , T , T , T , are expressed in °C.
M 1 2 3 4
201.3.212
* TEST LOAD
array of five TEST DEVICES used in a specified configuration (see Figure 201.101) for
performance tests of the INFANT RADIANT WARMER
– 12 – IEC 60601-2-21:2020 RLV © IEC 2020
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For ME EQUIPMENT or ME SYSTEMS, which combines alternative heat sources, for instance
incubators with integrated INFANT RADIANT WARMERS, devices supplying heat via BLANKETS,
PADS or MATTRESSES etc., safety requirements of other relevant particular standards shall be
considered. Further the safety requirements of this document shall be fulfilled with the
combination of the other equipment, which is approved by the MANUFACTURER, as stated in the
ACCOMPANYING DOCUMENTS according to Clause 16 (ME SYSTEMS).
Compliance is checked by the test of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-19:2020, etc.).
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
201.12.1.103, and generation of a visual
ESSENTIAL PERFORMANCE requirement 1
and audible alarm in compliance with
201.15.4.2.1
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition to item a):
The ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:
– an ambient temperature within the range 18 °C to 30 °C;
– an ambient air velocity is less than 0,3 m/s.
If not otherwise specified in this document, all tests shall be carried out at an ambient
temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Addition:
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT RADIANT WARMER not equipped with an integral oxygen monitor and which provides
means for oxygen administration shall be marked in a prominent position with a text which
states: "Use an oxygen monitor when oxygen is administered".
201.7.2.102 Distance markings
The INFANT RADIANT WARMER without integral bed areas shall be permanently and clearly
marked with an indication of the permissible distances between the INFANT RADIANT WARMER
heating systems and any MATTRESS.
201.7.4.2 Control devices
Addition:
Means shall be provided for the clear selection and indication of CONTROL TEMPERATURE on or
adjacent to the controls. The means provided shall allow resolution at intervals not greater
than 0,2 °C.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally contain:
a) a statement that independent monitoring of the temperature of the INFANT by the OPERATOR
is essential and it is inadvisable to leave an INFANT unattended under the INFANT RADIANT
WARMER;
b) recommendations on the permissible distances between the INFANT RADIANT WARMER
heating system and any MATTRESS used with it, and a statement on the effects which any
changes in this distance may have;
c) instructions on the recommended positions and methods of use and attachment of the
temperature sensors provided for use with the INFANT RADIANT WARMER;
d) for INFANT RADIANT WARMER with TYPE B APPLIED PART in which the INFANT might not be
isolated from earth, a warning that particular care shall be taken to ensure that additional
equipment connected to the INFANT is electrically safe;
e) if applicable, a recommendation to the OPERATOR to inspect regularly latches and closing
devices of barriers to prevent the INFANT falling out;
– 14 – IEC 60601-2-21:2020 RLV © IEC 2020
f) a statement of the maximum loads which can be applied to all supports and mounting
brackets for ACCESSORIES and ancillary equipment;
g) * information on the effects on the functioning of the INFANT RADIANT WARMER of
SKIN TEMPERATURE SENSOR from the PATIENT skin;
detachment of the
h) if applicable, a statement that the tilting of the MATTRESS from its horizontal position
relative to the INFANT RADIANT WARMER heater can affect the performance of the INFANT
RADIANT WARMER (see 201.12.1.102);
i) a statement that ACCESSORIES, e.g. for phototherapy or heated MATTRESSES, or sunlight
can cause an increase in INFANT temperature to dangerous levels;
INFANT RADIANT WARMER is not suitable for use in the presence of
j) a statement that the
flammable anaesthetic gases or other flammable materials, such as some types of
cleaning fluids;
k) a statement that rectal temperatures are not appropriate for controlling the heater output
INFANT RADIANT WARMER;
of the
l) * a statement that the INFANT RADIANT WARMER cannot differentiate between an increase in
core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
(hypothermia), and a recommendation to monitor the temperature of the PATIENT;
m) a statement that environmental conditions (e.g. air movement) can affect the thermal
balance of the INFANT;
INFANT RADIANT WARMER shall be used only by appropriately trained
n) * a statement that an
personnel and under the direction of qualified medical personnel who are familiar with
currently known RISKS and benefits of radiant warmer use;
o) a statement that an INFANT RADIANT WARMER can increase the PATIENT’s insensible water
loss;
p) concentration of carbon dioxide (CO ): If the MATTRESS of an INFANT RADIANT WARMER is
fitted with a COMPARTMENT which encloses the baby, the MANUFACTURER shall specify (see
201.12.4.2.101) in the ACCOMPANYING DOCUMENTS the maximum CO concentration which
COMPARTMENT during NORMAL CONDITIONS;
will occur in the
q) a statement that the INFANT RADIANT WARMER does not adjust for PATIENT temperature in
PREWARM MODE and that the mode shall be changed to MANUAL MODE or BABY CONTROLLED
RADIANT WARMER (baby mode) immediately when the PATIENT is placed on the device. The
MANUFACTURER shall disclose the level of heat in mW/cm when operating in PREWARM
MODE.
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall also contain
a) for each mode of control, a detailed statement describing the method by which the amount
of radiation is controlled and the temperature of the baby is maintained;
b) * if BABY CONTROLLED RADIANT WARMER operation is available, a statement to explain why
the OPERATOR should use this mode whenever possible.
201.7.9.2.13 * Maintenance
Addition:
If the source of radiation has a limited lifetime, the MANUFACTURER shall state, in the
ACCOMPANYING DOCUMENTS, the time after which the source of radiation shall be replaced
because of ageing.
CCESSORIES, supplementary equipment, used material
201.7.9.2.14 A
Addition:
The instructions for use shall include details of any specified combinations of INFANT RADIANT
WARMER with other equipment (see 201.4.1).
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
– the
concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.4.2.1 Instability in transport position
Addition:
The INFANT RADIANT WARMER and the mounting brackets and shelves are provided with the
most unfavourable combination of detachable parts and ACCESSORIES and are loaded with the
recommended maximum load.
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Addition:
201.9.6.2.1.101 * Audible alarms sound level
Auditory ALARM SIGNALS shall have a sound level of at least 65 dB(A) at a distance of 3 m from
the front of the INFANT RADIANT WARMER in a reflecting room. Other than the AUDIO PAUSED
specified in 201.12.3.103, the auditory ALARM SIGNAL may be adjusted by the OPERATOR to a
minimum lower level of 50 dB(A).
The sound pressure level of the ALARM SIGNAL shall not exceed 80 dB(A) on the MATTRESS.
If the frequency of the auditory ALARM SIGNAL is adjustable by the OPERATOR, these
requirements shall apply to all the individual selectable frequencies.
Compliance is checked with the microphone of a sound level meter complying with the
requirements of IEC 61672-1 placed 1,5 m above the floor and 3 m from the front of the
INFANT RADIANT WARMER.
Compliance of the maximum level is checked with each alarm sound means activated, the
sound level being measured at a point 5 cm above the centre of the MATTRESS.
Ensure that the background sound pressure level is at least 10 dB(A) below the measured
levels.
– 16 – IEC 60601-2-21:2020 RLV © IEC 2020
201.9.8 MECHANICAL HAZARDS associated with support systems
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for example an ACCESSORY shelf in the extended position
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 General
Addition:
The normal load for an INFANT is reduced to 10 kg.
Additional subclause:
201.9.8.3.101 Barriers
For INFANT RADIANT WARMERS with an integral bed area, suitable barriers shall be provided to
prevent the PATIENT from falling off the MATTRESS. Such barriers as intended to be opened or
removed to allow access to the PATIENT shall latch in their closed positions and shall remain
locked under the test conditions.
Compliance is checked by inspection and the following test: Apply to all the barriers (other
than those secured with the use of a TOOL) an outward horizontal force of 20 N to the centre
of each barrier for 5 s. The barriers shall remain closed.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies except as follows:
201.10.6 * Infrared radiation
Addition:
The maximum irradiance level at any point on the MATTRESS shall not exceed 60 mW/cm in
the total infrared spectrum.
The maximum irradiance level shall not exceed 10 mW/cm in the near infrared spectrum
(760 nm to 1 400 nm).
Compliance is checked by measurements.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of surfaces accessible to an INFANT on the MATTRESS shall not exceed 40 °C
for metal surfaces and 43 °C for other materials when the INFANT RADIANT WARMER is operating
under STEADY TEMPERATURE CONDITION at its maximum CONTROL TEMPERATURE.
Under conditions of warm-up to STEADY TEMPERATURE CONDITION or that of a SINGLE FAULT
CONDITION, these surfaces shall not exceed 42 °C for metal or 45 °C for other materials.
These requirements apply under NORMAL CONDITION and SINGLE FAULT CONDITIONS including:
– failure of the heater control circuit;
– failure of a SKIN TEMPERATURE SENSOR;
– disconnection of a SKIN TEMPERATURE SENSOR from the INFANT RADIANT WARMER.
201.11.1.4 * GUARDS
Addition:
If the heater element surface temperature exceeds 85 °C in NORMAL USE, heater GUARDS which
cannot exceed 85 °C in NORMAL USE shall be fitted.
Compliance is checked by measurement of the temperature and by performing the rigidity test
as described in 15.3.2 of the general standard. The heater GUARD shall not touch the heater
element.
201.11.2 *Fire prevention
Subclause 11.2 of the general standard applies.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
The INFANT RADIANT WARMER or ME SYSTEM shall be so constructed that in the event of spillage
of water (accidental wetting) on the PATIENT support or SKIN TEMPERATURE SENSOR, no HAZARD
shall result from the ingress of water.
INFANT RADIANT WARMER or
Compliance is checked by the following tests: Position the
ME SYSTEM in the least favourable position of NORMAL USE. In the case of an INFANT RADIANT
WARMER or ME SYSTEM with BABY CONTROLLED RADIANT WARMER operation, the SKIN
TEMPERATURE SENSOR shall be placed at the centre of the upper surface of the MATTRESS. Pour
200 ml of isotonic water (0,9 % saline) steadily on the centre of the MATTRESS over a period of
15 s.
INFANT RADIANT WARMER or ME SYSTEM shall meet the dielectric strength
After this test, the
requirements specified in 8.8.3 of the general standard and the INFANT RADIANT WARMER or
ME EQUIPMENT SYSTEM shall function normally.
– 18 – IEC 60601-2-21:2020 RLV © IEC 2020
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
The INFANT RADIANT WARMER shall be so designed that an interruption and restoration of the
power supply up to 10 min does not change the CONTROL TEMPERATURE or other preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on, and
inspecting the INFANT RADIANT WARMER.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 * Accuracy of SKIN TEMPERATURE SENSOR
The temperature measured by the SKIN TEMPERATURE SENSOR shall be continuously displayed
and clearly visible. The temperature displayed shall have an accuracy of ±0,3 °C. If the
display is used to present any other parameter, this shall only be obtained on demand, using
a momentary action switch. The range of displayed temperature shall be at least 30 °C to
40 °C.
Compliance is checked by inspection and the following test:
Immerse the SKIN TEMPERATURE SENSOR in a water bath maintained at 36 °C ± 0,1 °C. Position
a calibrated thermometer, accurate to within ±0,05 °C, with its bulb adjacent to the SKIN
TEMPERATURE SENSOR. The reading of the standard thermometer shall be compared with the
displayed temperature and their difference shall not exceed 0,3 °C less the calibrated
thermometer error.
201.12.1.102 * Accuracy of distribution of irradiation to the MATTRESS
The difference between the MID-POINT AVERAGE TEMPERATURE and the TEST DEVICE AVERAGE
TEMPERATURE of any of the other devices comprising the TEST LOAD shall not exceed 2 °C.
Compliance is checked by the following test: Prepare five TEST DEVICES consisting of
aluminium discs each with a mass of 500 g ± 10 g and a diameter of 100 mm ± 2 mm. Drill
5 mm diameter holes 50 mm ± 2 mm deep as shown in Figure 201.102 and coat the entire
disc surface with non-reflective black paint.
NOTE The disc thickness will be approximately 23 mm.
Subject the INFANT RADIANT WARMER to the following test in a room in which the maximum air
velocity is 0,1 m/s and the ambient temperature is maintained at 23 °C ± 2 °C.
Place four individually identified TEST DEVICES, marked 1, 2, 3 and 4 on the horizontal
MATTRESS at the centres of each of four rectangles formed by bisecting the length and width of
the MATTRESS as shown in Figure 201.101. Place a fifth TEST DEVICE marked "M" on the mid-
point of the MATTRESS. Insert a temperature sensor in each of the five TEST DEVICE centres
and, in the case of an INFANT RADIANT WARMER with BABY CONTROLLED RADIANT WARMER
operation, attach the SKIN TEMPERATURE SENSOR to the centre of the upper surface of the TEST
DEVICE "M", assuring a good thermal conductive contact (e.g. thermal paste). In the case of an
INFANT RADIANT WARMER with a BABY CONTROLLED RADIANT WARMER operation, set the
temperature control to a CONTROL TEMPERATURE of 36 °C ± 0,1 °C and operate the INFANT
RADIANT WARMER until a STEADY TEMPERATURE CONDITION is obtained. In the case of an INFANT
RADIANT WARMER with only a MANUAL MODE, set the heater output so that the TEST DEVICE will
warm up to approximately 36 °C under STEADY TEMPERATURE CONDITION. Take at least
20 readings of temperature of each TEST DEVICE at regular intervals over a 60 min period.
Calculate the five values of the TEST DEVICE AVERAGE TEMPERATURE for each TEST DEVICE as
follows:
(t + t + t + t + .t )
11 12 13 14 1n
T =
n
where
T is the TEST DEVICE AVERAGE TEMPERATURE for TEST DEVICE no. 1;
t t are the individual temperature readings taken of TEST DEVICE no. 1 at regular
….
11 1n
i
...
IEC 60601-2-21 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et
les performances essentielles des incubateurs radiants pour nouveau-nés
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IEC 60601-2-21 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et
les performances essentielles des incubateurs radiants pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-8722-4
– 2 – IEC 60601-2-21:2020 © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic disturbances – Requirements and tests . 23
Annexes . 24
Annex AA (informative) Particular guidance and rationale . 25
Bibliography . 34
Index of defined terms used in this document . 36
Figure 201.101 – Layout of TEST DEVICES . 10
Figure 201.102 – TEST DEVICE . 11
Figure AA.1 – Illustration of the main requirements of this document . 25
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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) 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 60601-2-21 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
– 4 – IEC 60601-2-21:2020 © IEC 2020
The text of this international standard is based on the following documents:
FDIS Report on voting
62D/1766/FDIS 62D/1776/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD 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 standard 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 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 document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
– 6 – IEC 60601-2-21:2020 © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT RADIANT WARMER equipment.
This particular standard amends and supplements IEC 60601-1, Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance, hereinafter
referred to as the "general standard".
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate
the proper application of this particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, Annex AA does not form part of the requirements of this document.
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but
alternate methods of compliance with a specific clause, by demonstrating equivalent safety,
will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
• devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35;
• INFANT INCUBATORS; for information, see IEC 60601-2-19;
• INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
• INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
_______________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
– 8 – IEC 60601-2-21:2020 © IEC 2020
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204, which
minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with
the requirements can be verified.
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.
IEC 60601-1-2:2014 applies as modified in Clauses 202. 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.
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
under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
EQUIPMENT
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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 and
applicable collateral standards 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 3.147, 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.
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 document" 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.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
201.3 Terms and definitions
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 36.
Addition:
201.3.201
BABY CONTROLLED RADIANT WARMER
mode of operation in which the power output varies automatically in order to maintain the
temperature as measured by a SKIN TEMPERATURE SENSOR according to the CONTROL
TEMPERATURE set by the OPERATOR
201.3.202
CONTROL TEMPERATURE
temperature selected at the temperature control
– 10 – IEC 60601-2-21:2020 © IEC 2020
201.3.203
INFANT
PATIENT up to 3 months and with a weight of less than 10 kg
201.3.204
INFANT RADIANT WARMER
electrically powered device with a radiant heating source intended to maintain the thermal
balance of an INFANT by direct radiation of energy in the infrared region of the electromagnetic
spectrum
201.3.205
MANUAL MODE
mode of operation in which the heater output is either at a fixed level or a proportion of its
OPERATOR
maximum output set by the
201.3.206
MID-POINT AVERAGE TEMPERATURE
T
M
AVERAGE TEMPERATURE of the TEST DEVICE positioned at the mid-point of the INFANT RADIANT
WARMER MATTRESS (see Figure 201.101)
Figure 201.101 – Layout of TEST DEVICES
201.3.207
*
PREWARM MODE
mode of operation in which the heater output is maintained at a preset level (set by the
MANUFACTURER) for the purpose of pre-warming the INFANT RADIANT WARMER and maintaining
the level of warmth of the INFANT RADIANT WARMER prior to an INFANT being placed on the
device
201.3.208
SKIN TEMPERATURE SENSOR
INFANT’s SKIN TEMPERATURE
sensing device intended to measure the
201.3.209
STEADY TEMPERATURE CONDITION
condition which is reached when the temperature, measured at the centre of the TEST DEVICE
positioned on the mid-point of the INFANT RADIANT WARMER MATTRESS, does not vary by more
than 1 °C over a period of 1 h
201.3.210
TEST DEVICE
totally matt blackened disc used as a reproducible receiver of radiant energy during testing of
the INFANT RADIANT WARMER (see Figure 201.102)
Dimensions in millimetres
Surface finish: non-reflective black paint
Disc mass: 500 g ± 10 g
3 3
Disc material: aluminium of density within the range 2,6 g/cm and 2,9 g/cm
Figure 201.102 – TEST DEVICE
201.3.211
TEST DEVICE AVERAGE TEMPERATURE
(T , T , T , T OR T )
1 2 3 4 M
AVERAGE TEMPERATURE reading taken during a STEADY TEMPERATURE CONDITION at regular
intervals at the centre of a TEST DEVICE
Note 1 to entry: T , T , T , T , T , are expressed in °C.
M 1 2 3 4
201.3.212
* TEST LOAD
array of five TEST DEVICES used in a specified configuration (see Figure 201.101) for
performance tests of the INFANT RADIANT WARMER
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For ME EQUIPMENT or ME SYSTEMS, which combines alternative heat sources, for instance
incubators with integrated INFANT RADIANT WARMERS, devices supplying heat via BLANKETS,
PADS or MATTRESSES etc., safety requirements of other relevant particular standards shall be
considered. Further the safety requirements of this document shall be fulfilled with the
combination of the other equipment, which is approved by the MANUFACTURER, as stated in the
ACCOMPANYING DOCUMENTS according to Clause 16.
Compliance is checked by the test of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-19:2020, etc.).
201.4.3 ESSENTIAL PERFORMANCE
Addition:
– 12 – IEC 60601-2-21:2020 © IEC 2020
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.103, and generation of a visual
and audible alarm in compliance with
201.15.4.2.1
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition to item a):
The ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:
– an ambient temperature within the range 18 °C to 30 °C;
– an ambient air velocity is less than 0,3 m/s.
If not otherwise specified in this document, all tests shall be carried out at an ambient
temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT RADIANT WARMER not equipped with an integral oxygen monitor and which provides
means for oxygen administration shall be marked in a prominent position with a text which
states: "Use an oxygen monitor when oxygen is administered".
201.7.2.102 Distance markings
The INFANT RADIANT WARMER without integral bed areas shall be permanently and clearly
marked with an indication of the permissible distances between the INFANT RADIANT WARMER
heating systems and any MATTRESS.
201.7.4.2 Control devices
Addition:
Means shall be provided for the clear selection and indication of CONTROL TEMPERATURE on or
adjacent to the controls. The means provided shall allow resolution at intervals not greater
than 0,2 °C.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally contain:
a) a statement that independent monitoring of the temperature of the INFANT by the OPERATOR
INFANT unattended under the INFANT RADIANT
is essential and it is inadvisable to leave an
WARMER;
b) recommendations on the permissible distances between the INFANT RADIANT WARMER
heating system and any MATTRESS used with it, and a statement on the effects which any
changes in this distance may have;
c) instructions on the recommended positions and methods of use and attachment of the
temperature sensors provided for use with the INFANT RADIANT WARMER;
d) for INFANT RADIANT WARMER with TYPE B APPLIED PART in which the INFANT might not be
isolated from earth, a warning that particular care shall be taken to ensure that additional
equipment connected to the INFANT is electrically safe;
OPERATOR to inspect regularly latches and closing
e) if applicable, a recommendation to the
devices of barriers to prevent the INFANT falling out;
f) a statement of the maximum loads which can be applied to all supports and mounting
brackets for ACCESSORIES and ancillary equipment;
g) * information on the effects on the functioning of the INFANT RADIANT WARMER of
detachment of the SKIN TEMPERATURE SENSOR from the PATIENT skin;
MATTRESS from its horizontal position
h) if applicable, a statement that the tilting of the
relative to the INFANT RADIANT WARMER heater can affect the performance of the INFANT
RADIANT WARMER (see 201.12.1.102);
i) a statement that ACCESSORIES, e.g. for phototherapy or heated MATTRESSES, or sunlight
INFANT temperature to dangerous levels;
can cause an increase in
j) a statement that the INFANT RADIANT WARMER is not suitable for use in the presence of
flammable anaesthetic gases or other flammable materials, such as some types of
cleaning fluids;
k) a statement that rectal temperatures are not appropriate for controlling the heater output
of the INFANT RADIANT WARMER;
l) * a statement that the INFANT RADIANT WARMER cannot differentiate between an increase in
core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
(hypothermia), and a recommendation to monitor the temperature of the PATIENT;
m) a statement that environmental conditions (e.g. air movement) can affect the thermal
INFANT;
balance of the
n) * a statement that an INFANT RADIANT WARMER shall be used only by appropriately trained
personnel and under the direction of qualified medical personnel who are familiar with
currently known RISKS and benefits of radiant warmer use;
– 14 – IEC 60601-2-21:2020 © IEC 2020
o) a statement that an INFANT RADIANT WARMER can increase the PATIENT’s insensible water
loss;
p) concentration of carbon dioxide (CO ): If the MATTRESS of an INFANT RADIANT WARMER is
COMPARTMENT which encloses the baby, the MANUFACTURER shall specify (see
fitted with a
201.12.4.2.101) in the ACCOMPANYING DOCUMENTS the maximum CO concentration which
will occur in the COMPARTMENT during NORMAL CONDITIONS;
q) a statement that the INFANT RADIANT WARMER does not adjust for PATIENT temperature in
PREWARM MODE and that the mode shall be changed to MANUAL MODE or BABY CONTROLLED
RADIANT WARMER (baby mode) immediately when the PATIENT is placed on the device. The
MANUFACTURER shall disclose the level of heat in mW/cm when operating in PREWARM
MODE.
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall also contain
a) for each mode of control, a detailed statement describing the method by which the amount
of radiation is controlled and the temperature of the baby is maintained;
b) * if BABY CONTROLLED RADIANT WARMER operation is available, a statement to explain why
OPERATOR should use this mode whenever possible.
the
201.7.9.2.13 * Maintenance
Addition:
If the source of radiation has a limited lifetime, the MANUFACTURER shall state, in the
ACCOMPANYING DOCUMENTS, the time after which the source of radiation shall be replaced
because of ageing.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Addition:
The instructions for use shall include details of any specified combinations of INFANT RADIANT
WARMER with other equipment (see 201.4.1).
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.4.2.1 Instability in transport position
Addition:
The INFANT RADIANT WARMER and the mounting brackets and shelves are provided with the
most unfavourable combination of detachable parts and ACCESSORIES and are loaded with the
recommended maximum load.
201.9.6.2.1 Audible acoustic energy
Addition:
201.9.6.2.1.101 * Audible alarms sound level
Auditory ALARM SIGNALS shall have a sound level of at least 65 dB(A) at a distance of 3 m from
INFANT RADIANT WARMER in a reflecting room. Other than the AUDIO PAUSED
the front of the
specified in 201.12.3.103, the auditory ALARM SIGNAL may be adjusted by the OPERATOR to a
minimum lower level of 50 dB(A).
The sound pressure level of the ALARM SIGNAL shall not exceed 80 dB(A) on the MATTRESS.
If the frequency of the auditory ALARM SIGNAL is adjustable by the OPERATOR, these
requirements shall apply to all the individual selectable frequencies.
Compliance is checked with the microphone of a sound level meter complying with the
requirements of IEC 61672-1 placed 1,5 m above the floor and 3 m from the front of the
INFANT RADIANT WARMER.
Compliance of the maximum level is checked with each alarm sound means activated, the
sound level being measured at a point 5 cm above the centre of the MATTRESS.
Ensure that the background sound pressure level is at least 10 dB(A) below the measured
levels.
201.9.8 MECHANICAL HAZARDS associated with support systems
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for example an ACCESSORY shelf in the extended position
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 General
Addition:
The normal load for an INFANT is reduced to 10 kg.
– 16 – IEC 60601-2-21:2020 © IEC 2020
Additional subclause:
201.9.8.3.101 Barriers
For INFANT RADIANT WARMERS with an integral bed area, suitable barriers shall be provided to
prevent the PATIENT from falling off the MATTRESS. Such barriers as intended to be opened or
removed to allow access to the PATIENT shall latch in their closed positions and shall remain
locked under the test conditions.
Compliance is checked by inspection and the following test: Apply to all the barriers (other
TOOL) an outward horizontal force of 20 N to the centre
than those secured with the use of a
of each barrier for 5 s. The barriers shall remain closed.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies except as follows:
201.10.6 * Infrared radiation
Addition:
The maximum irradiance level at any point on the MATTRESS shall not exceed 60 mW/cm in
the total infrared spectrum.
in the near infrared spectrum
The maximum irradiance level shall not exceed 10 mW/cm
(760 nm to 1 400 nm).
Compliance is checked by measurements.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of surfaces accessible to an INFANT on the MATTRESS shall not exceed 40 °C
for metal surfaces and 43 °C for other materials when the INFANT RADIANT WARMER is operating
under STEADY TEMPERATURE CONDITION at its maximum CONTROL TEMPERATURE.
Under conditions of warm-up to STEADY TEMPERATURE CONDITION or that of a SINGLE FAULT
CONDITION, these surfaces shall not exceed 42 °C for metal or 45 °C for other materials.
These requirements apply under NORMAL CONDITION and SINGLE FAULT CONDITIONS including:
– failure of the heater control circuit;
– failure of a SKIN TEMPERATURE SENSOR;
– disconnection of a SKIN TEMPERATURE SENSOR from the INFANT RADIANT WARMER.
201.11.1.4 * GUARDS
Addition:
If the heater element surface temperature exceeds 85 °C in NORMAL USE, heater GUARDS which
cannot exceed 85 °C in NORMAL USE shall be fitted.
Compliance is checked by measurement of the temperature and by performing the rigidity test
as described in 15.3.2 of the general standard. The heater GUARD shall not touch the heater
element.
201.11.2 *Fire prevention
Subclause 11.2 of the general standard applies.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
The INFANT RADIANT WARMER or ME SYSTEM shall be so constructed that in the event of spillage
of water (accidental wetting) on the PATIENT support or SKIN TEMPERATURE SENSOR, no HAZARD
shall result from the ingress of water.
Compliance is checked by the following tests: Position the INFANT RADIANT WARMER or
ME SYSTEM in the least favourable position of NORMAL USE. In the case of an INFANT RADIANT
WARMER or ME SYSTEM with BABY CONTROLLED RADIANT WARMER operation, the SKIN
TEMPERATURE SENSOR shall be placed at the centre of the upper surface of the MATTRESS. Pour
200 ml of isotonic water (0,9 % saline) steadily on the centre of the MATTRESS over a period of
15 s.
After this test, the INFANT RADIANT WARMER or ME SYSTEM shall meet the dielectric strength
requirements specified in 8.8.3 of the general standard and the INFANT RADIANT WARMER or
ME SYSTEM shall function normally.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
The INFANT RADIANT WARMER shall be so designed that an interruption and restoration of the
power supply up to 10 min does not change the CONTROL TEMPERATURE or other preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on, and
inspecting the INFANT RADIANT WARMER.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 * Accuracy of SKIN TEMPERATURE SENSOR
The temperature measured by the SKIN TEMPERATURE SENSOR shall be continuously displayed
and clearly visible. The temperature displayed shall have an accuracy of ±0,3 °C. If the
display is used to present any other parameter, this shall only be obtained on demand, using
a momentary action switch. The range of displayed temperature shall be at least 30 °C to
40 °C.
Compliance is checked by inspection and the following test:
– 18 – IEC 60601-2-21:2020 © IEC 2020
Immerse the SKIN TEMPERATURE SENSOR in a water bath maintained at 36 °C ± 0,1 °C. Position
a calibrated thermometer, accurate to within ±0,05 °C, with its bulb adjacent to the SKIN
TEMPERATURE SENSOR. The reading of the standard thermometer shall be compared with the
displayed temperature and their difference shall not exceed 0,3 °C less the calibrated
thermometer error.
MATTRESS
201.12.1.102 * Accuracy of distribution of irradiation to the
The difference between the MID-POINT AVERAGE TEMPERATURE and the TEST DEVICE AVERAGE
of any of the other devices comprising the TEST LOAD shall not exceed 2 °C.
TEMPERATURE
Compliance is checked by the following test: Prepare five TEST DEVICES consisting of
aluminium discs each with a mass of 500 g ± 10 g and a diameter of 100 mm ± 2 mm. Drill
5 mm diameter holes 50 mm ± 2 mm deep as shown in Figure 201.102 and coat the entire
disc surface with non-reflective black paint.
NOTE The disc thickness will be approximately 23 mm.
Subject the INFANT RADIANT WARMER to the following test in a room in which the maximum air
velocity is 0,1 m/s and the ambient temperature is maintained at 23 °C ± 2 °C.
Place four individually identified TEST DEVICES, marked 1, 2, 3 and 4 on the horizontal
MATTRESS at the centres of each of four rectangles formed by bisecting the length and width of
the MATTRESS as shown in Figure 201.101. Place a fifth TEST DEVICE marked "M" on the mid-
point of the MATTRESS. Insert a temperature sensor in each of the five TEST DEVICE centres
and, in the case of an INFANT
...
IEC 60601-2-21 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential performance
of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs radiants pour nouveau-nés
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IEC 60601-2-21 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential performance
of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs radiants pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-7806-2
IEC 60601-2-21 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential performance
of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs radiants pour nouveau-nés
– 2 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 * Electromagnetic disturbances – Requirements and tests . 23
Annexes . 25
Annex AA (informative) Particular guidance and rationale . 26
Bibliography . 35
Index of defined terms used in this document . 38
Figure 201.101 – Layout of TEST DEVICES . 10
Figure 201.102 – TEST DEVICE . 11
Figure AA.1 – Illustration of the main requirements of this document . 26
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-21 edition 3.1 contains the third edition (2020-09) [documents
62D/1766/FDIS and 62D/1776/RVD] and its amendment 1 (2023-11) [documents
62D/2077/FDIS and 62D/2095/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
– 4 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
International standard IEC 60601-2-21 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD 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 standard 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 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
© IEC 2023
The committee has decided that the contents of this document and its amendment 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,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT RADIANT WARMER equipment.
This particular standard amends and supplements IEC 60601-1, Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance, hereinafter
referred to as the "general standard".
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate
the proper application of this particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, Annex AA does not form part of the requirements of this document.
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1816/RR.
© IEC 2023
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but
alternate methods of compliance with a specific clause, by demonstrating equivalent safety,
will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
• devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35;
• INFANT INCUBATORS; for information, see IEC 60601-2-19;
• INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
• INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
_______________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
– 8 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204, which
minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with
the requirements can be verified.
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.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 applies apply as modified in
Clauses 202. 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.
If a BABY CONTROLLED RADIANT WARMER is based on a temperature measurement which is
substantially influenced by the INFANT'S core or body temperature IEC 60601-1-10:2007,
IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 apply. Examples for
temperature measurements stipulating applicability of IEC 60601-1-10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 are provided in
Annex AA.
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 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 are 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 document 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 and
applicable collateral standards 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.
© IEC 2023
"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 3.147, 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.
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 document" 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.
If an INFANT RADIANT WARMER is supplied with dedicated physiological monitoring, then
IEC 80601-2-49 [34] applies. Measured parameters related to the inherent function of an
INFANT RADIANT WARMER i.e. the SKIN TEMPERATURE, are not considered to be a physiological
monitoring unit as per IEC 80601-2-49 [34].
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
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
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
201.3 Terms and definitions
For the purposes of this document, the terms and definitions specified 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 terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
– 10 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 38.
Addition:
201.3.201
BABY CONTROLLED RADIANT WARMER
mode of operation in which the power output varies automatically in order to maintain the
temperature as measured by a SKIN TEMPERATURE SENSOR according to the CONTROL
TEMPERATURE set by the OPERATOR
201.3.202
CONTROL TEMPERATURE
temperature selected at the temperature control
201.3.203
INFANT
PATIENT up to 3 months and with a weight of less than 10 kg
Note 1 to entry: INFANT includes premature/pre-born baby and neonate baby/newborn baby.
201.3.204
INFANT RADIANT WARMER
electrically powered device with a radiant heating source intended to maintain the thermal
balance of an INFANT by direct radiation of energy in the infrared region of the electromagnetic
spectrum
201.3.205
MANUAL MODE
mode of operation in which the heater output is either at a fixed level or a proportion of its
maximum output set by the OPERATOR
201.3.206
MID-POINT AVERAGE TEMPERATURE
T
M
AVERAGE TEMPERATURE of the TEST DEVICE positioned at the mid-point of the INFANT RADIANT
WARMER MATTRESS (see Figure 201.101)
Figure 201.101 – Layout of TEST DEVICES
© IEC 2023
201.3.207
*
PREWARM MODE
mode of operation in which the heater output is maintained at a preset level (set by the
MANUFACTURER) for the purpose of pre-warming the INFANT RADIANT WARMER and maintaining
the level of warmth of the INFANT RADIANT WARMER prior to an INFANT being placed on the
device
201.3.208
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT’s SKIN TEMPERATURE
201.3.209
STEADY TEMPERATURE CONDITION
TEST DEVICE
condition which is reached when the temperature, measured at the centre of the
positioned on the mid-point of the INFANT RADIANT WARMER MATTRESS, does not vary by more
than 1 °C over a period of 1 h
201.3.210
TEST DEVICE
totally matt blackened disc used as a reproducible receiver of radiant energy during testing of
INFANT RADIANT WARMER (see Figure 201.102)
the
Dimensions in millimetres
Surface finish: non-reflective black paint
Disc mass: 500 g ± 10 g
3 3
Disc material: aluminium of density within the range 2,6 g/cm and 2,9 g/cm
Figure 201.102 – TEST DEVICE
201.3.211
TEST DEVICE AVERAGE TEMPERATURE
(T , T , T , T OR T )
1 2 3 4 M
AVERAGE TEMPERATURE reading taken during a STEADY TEMPERATURE CONDITION at regular
intervals at the centre of a TEST DEVICE
Note 1 to entry: T , T , T , T , T , are expressed in °C.
M 1 2 3 4
201.3.212
* TEST LOAD
array of five TEST DEVICES used in a specified configuration (see Figure 201.101) for
INFANT RADIANT WARMER
performance tests of the
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
– 12 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For ME EQUIPMENT or ME SYSTEMS, which combines alternative heat sources, for instance
incubators with integrated INFANT RADIANT WARMERS, devices supplying heat via BLANKETS,
PADS or MATTRESSES etc., safety requirements of other relevant particular standards shall be
considered. Further the safety requirements of this document shall be fulfilled with the
combination of the other equipment, which is approved by the MANUFACTURER, as stated in the
ACCOMPANYING DOCUMENTS according to Clause 16.
Compliance is checked by the test of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-19:2020, etc.).
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.103, and or generation of a
visual and audible alarm in compliance
with 201.15.4.2.1
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Addition to item a):
The ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:
– an ambient temperature within the range 18 °C to 30 °C;
– an ambient air velocity is less than 0,3 m/s.
If not otherwise specified in this document, all tests shall be carried out at an ambient
temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
© IEC 2023
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT RADIANT WARMER not equipped with an integral oxygen monitor and which provides
means for oxygen administration shall be marked in a prominent position with a text which
states: "Use an oxygen monitor when oxygen is administered".
201.7.2.102 Distance markings
The INFANT RADIANT WARMER without integral bed areas shall be permanently and clearly
marked with an indication of the permissible distances between the INFANT RADIANT WARMER
heating systems and any MATTRESS.
201.7.4.2 Control devices
Addition:
CONTROL TEMPERATURE on or
Means shall be provided for the clear selection and indication of
adjacent to the controls. The means provided shall allow resolution at intervals not greater
than 0,2 °C.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally contain:
a) a statement that independent monitoring of the temperature of the INFANT by the OPERATOR
is essential and it is inadvisable to leave an INFANT unattended under the INFANT RADIANT
WARMER;
b) recommendations on the permissible distances between the INFANT RADIANT WARMER
heating system and any MATTRESS used with it, and a statement on the effects which any
changes in this distance may have;
c) instructions on the recommended positions and methods of use and attachment of the
temperature sensors provided for use with the INFANT RADIANT WARMER;
d) for INFANT RADIANT WARMER with TYPE B APPLIED PART in which the INFANT might not be
isolated from earth, a warning that particular care shall be taken to ensure that additional
equipment connected to the INFANT is electrically safe;
e) if applicable, a recommendation to the OPERATOR to inspect regularly latches and closing
devices of barriers to prevent the INFANT falling out;
f) a statement of the maximum loads which can be applied to all supports and mounting
brackets for ACCESSORIES and ancillary equipment;
g) * information on the effects on the functioning of the INFANT RADIANT WARMER of
detachment of the SKIN TEMPERATURE SENSOR from the PATIENT skin;
h) if applicable, a statement that the tilting of the MATTRESS from its horizontal position
relative to the INFANT RADIANT WARMER heater can affect the performance of the INFANT
RADIANT WARMER (see 201.12.1.102);
– 14 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
i) a statement that ACCESSORIES, e.g. for phototherapy or heated MATTRESSES, or sunlight
can cause an increase in INFANT temperature to dangerous levels;
j) a statement that the INFANT RADIANT WARMER is not suitable for use in the presence of
flammable anaesthetic gases or other flammable materials, such as some types of
cleaning fluids;
k) a statement that rectal temperatures are not appropriate for controlling the heater output
of the INFANT RADIANT WARMER;
l) * a statement that the INFANT RADIANT WARMER cannot differentiate between an increase in
core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
(hypothermia), and a recommendation to monitor the temperature of the PATIENT;
m) a statement that environmental conditions (e.g. air movement) can affect the thermal
balance of the INFANT;
n) * a statement that an INFANT RADIANT WARMER shall be used only by appropriately trained
personnel and under the direction of qualified medical personnel who are familiar with
currently known RISKS and benefits of radiant warmer use;
o) a statement that an INFANT RADIANT WARMER can increase the PATIENT’s insensible water
loss;
p) concentration of carbon dioxide (CO ): If the MATTRESS of an INFANT RADIANT WARMER is
fitted with a COMPARTMENT which encloses the baby, the MANUFACTURER shall specify (see
201.12.4.2.101) in the ACCOMPANYING DOCUMENTS the maximum CO concentration which
will occur in the COMPARTMENT during NORMAL CONDITIONS;
q) a statement that the INFANT RADIANT WARMER does not adjust for PATIENT temperature in
PREWARM MODE and that the mode shall be changed to MANUAL MODE or BABY CONTROLLED
RADIANT WARMER (baby mode) immediately when the PATIENT is placed on the device. The
MANUFACTURER shall disclose the level of heat in mW/cm or in % of the maximum heater
PREWARM MODE.
output when operating in
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall also contain
a) for each mode of control, a detailed statement describing the method by which the amount
of radiation is controlled and the temperature of the baby is maintained;
b) * if BABY CONTROLLED RADIANT WARMER operation is available, a statement to explain why
the OPERATOR should use this mode whenever possible.
201.7.9.2.13 * Maintenance
Addition:
If the source of radiation has a limited lifetime, the MANUFACTURER shall state, in the
ACCOMPANYING DOCUMENTS, the time after which the source of radiation shall be replaced
because of ageing.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Addition:
The instructions for use shall include details of any specified combinations of INFANT RADIANT
with other equipment (see 201.4.1).
WARMER
© IEC 2023
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.4.2.1 Instability in transport position
Addition:
The INFANT RADIANT WARMER and the mounting brackets and shelves are provided with the
most unfavourable combination of detachable parts and ACCESSORIES and are loaded with the
recommended maximum load.
201.9.6.2.1 Audible acoustic energy
Addition:
201.9.6.2.1.101 * Audible alarms sound level
Auditory ALARM SIGNALS shall have a sound level of at least 65 dB(A) at a distance of 3 m from
the front of the INFANT RADIANT WARMER in a reflecting room. Other than the AUDIO PAUSED
specified in 201.12.3.103, the auditory ALARM SIGNAL may be adjusted by the OPERATOR to a
minimum lower level of 50 dB(A).
The sound pressure level of the ALARM SIGNAL shall not exceed 80 dB(A) on the MATTRESS.
If the frequency of the auditory ALARM SIGNAL is adjustable by the OPERATOR, these
requirements shall apply to all the individual selectable frequencies.
Compliance is checked with the microphone of a sound level meter complying with the
requirements of IEC 61672-1 placed 1,5 m above the floor and 3 m from the front of the
INFANT RADIANT WARMER.
Compliance of the maximum level is checked with each alarm sound means activated, the
sound level being measured at a point 5 cm above the centre of the MATTRESS.
Ensure that the background sound pressure level is at least 10 dB(A) below the measured
levels.
The audible HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNALS shall have a sound level of at
least 57 dBA. The auditory alarm may be adjusted by the OPERATOR to a minimum lower level
of 42 dBA.
– 16 – IEC 60601-2-21:2020+AMD1:2023 CSV
© IEC 2023
Compliance is checked by inspection and measurement of the audible alarm level as specified
in 6.3.3.2 of IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601‑1‑8:2006/AMD2:2020.
201.9.8 MECHANICAL HAZARDS associated with support systems
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for example an ACCESSORY shelf in the extended position
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 General
Addition:
The normal load for an INFANT is reduced to 10 kg.
Additional subclause:
201.9.8.3.101 Barriers
For INFANT RADIANT WARMERS with an integral bed area, suitable barriers shall be provided to
prevent the PATIENT from falling off the MATTRESS. Such barriers as intended to be opened or
removed to allow access to the PATIENT shall latch in their closed positions and shall remain
locked under the test conditions.
Compliance is checked by inspection and the following test: Apply to all the barriers (other
than those secured with the use of a TOOL) an outward horizontal force of 20 N to the centre
of each barrier for 5 s. The barriers shall remain closed.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies except as follows:
201.10.6 * Infrared radiation
Addition:
The maximum irradiance level at any point on the MATTRESS shall not exceed 60 mW/cm in
the total infrared spectrum.
The maximum irradiance level shall not exceed 10 mW/cm in the near infrared spectrum
(760 nm to 1 400 nm).
Compliance is checked by measurements.
© IEC 2023
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of surfaces accessible to an INFANT on the MATTRESS shall not exceed 40 °C
for metal surfaces and 43 °C for other materials when the INFANT RADIANT WARMER is operating
under STEADY TEMPERATURE CONDITION at its maximum CONTROL TEMPERATURE.
Under conditions of warm-up to STEADY TEMPERATURE CONDITION or that of a SINGLE FAULT
CONDITION, these surfaces shall not exceed 42 °C for metal or 45 °C for other materials.
These requirements apply under NORMAL CONDITION and SINGLE FAULT CONDITIONS including:
– failure of the heater control circuit;
– failure of a SKIN TEMPERATURE SENSOR;
– disconnection of a SKIN TEMPERATURE SENSOR from the INFANT RADIANT WARMER.
201.11.1.4 * GUARDS
Addition:
If the heater element surface temperature exceeds 85 °C in NORMAL USE, heater GUARDS which
cannot exceed 85 °C in NORMAL USE shall be fitted.
Compliance is checked by measurement of the temperature and by performing the rigidity test
as described in 15.3.2 of the general standard. The heater GUARD shall not touch the heater
element.
201.11.2 *Fire prevention
Subclause 11.2 of the general standard applies.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
The INFANT RADIANT WARMER or ME SYSTEM shall be so constructed that in the event of spillage
of water (accidental wetting) on the PATIENT support or SKIN TEMPERATURE SENSOR, no HAZARD
shall result from the ingress of water.
INFANT RADIANT WARMER or
Compliance is checked by the following tests: Position the
ME SYSTEM in the least favourable position of NORMAL USE. In the case of an INFANT RADI
...
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