EN 60601-2-21:2009

SLOVENSKI STANDARD
01-julij-2009
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Medical electrical equipment - Part 2-21: Particular requirements for basic safety and
essential performance of infant radiant warmers (IEC 60601-2-21:2009)
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC
60601-2-21:2009)
Appareils électromédicaux - Partie 2-21: Exigences particulières de sécurité de base et
de performances essentielles des incubateurs radiants pour nouveau-nés (CEI 60601-2-
21:2009)
Ta slovenski standard je istoveten z: EN 60601-2-21:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-21
NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 60601-2-21:1994 + A1:1996

English version
Medical electrical equipment -
Part 2-21: Particular requirements
for the basic safety and essential performance
of infant radiant warmers
(IEC 60601-2-21:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-21: Exigences particulières Teil 2-21: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des incubateurs radiants von Säuglingswärmestrahlern
pour nouveau-nés (IEC 60601-2-21:2009)
(CEI 60601-2-21:2009)
This European Standard was approved by CENELEC on 2009-04-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

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

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-21:2009 E
Foreword
The text of document 62D/735/FDIS, future edition 2 of IEC 60601-2-21, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-21 on 2009-04-01.
This European Standard supersedes EN 60601-2-21:1994 + A1:1996.
EN 60601-2-21:1994 was revised to structurally align with EN 60601-1:2006.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-04-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.

- 3 - EN 60601-2-21:2009
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-21:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335-2-27 NOTE  Harmonized as EN 60335-2-27:2003 (not modified).
IEC 60601-2-19 NOTE  Harmonized as EN 60601-2-19:2009 (not modified).
IEC 60601-2-50 NOTE  Harmonized as EN 60601-2-50:2009 (not modified).
IEC 61672-1 NOTE  Harmonized as EN 61672-1:2003 (not modified).
ISO 3743-1 NOTE  Harmonized as EN ISO 3743-1:1995 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace the reference to IEC 60601-1-2 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) 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 - EN 60601-1-10 2008
Part 1-10: General requirements for basic
safety and essential performance - Collateral
Standard: Requirements for the development
of physiologic closed-loop controllers

- 5 - EN 60601-2-21:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
IEC 60601-2-21 ®
Edition 2.0 2009-02
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
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.10 ISBN 2-8318-1032-9
– 2 – 60601-2-21 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.5
201.1 Scope, object and related standards .6
201.2 Normative references .8
201.3 Terms and definitions.8
201.4 General requirements.10
201.5 General requirements for testing of ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.13
201.10 Protection against unwanted and excessive radiation HAZARDS.15
201.11 Protection against excessive temperatures and other HAZARDS.15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.16
201.13 HAZARDOUS SITUATIONS and fault conditions.20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .20
201.15 Construction of ME EQUIPMENT .20
201.16 ME SYSTEMS .22
*
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .22
202 Electromagnetic compatibility – Requirements and tests .22
210 Requirements for the development of physiologic closed-loop controllers .22
Annexes .23
Annex AA (informative) Particular guidance and rationale.24
Bibliography.32
Index of defined terms used in this particular standard.34

Figure 201.101 – Layout of TEST DEVICES .9
Figure 201.102 – TEST DEVICE.10

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements.11

60601-2-21 © IEC:2009 – 3 –
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.
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 second edition cancels and replaces the first edition published in 1994 and its
Amendment 1 (1996). This edition constitutes a technical revision. This edition of
IEC 60601-2-21 was revised to structurally align with the 2005 edition of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/735/FDIS 62D/762/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

– 4 – 60601-2-21 © IEC:2009
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-21 © IEC:2009 – 5 –
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, this annex does not form part of the requirements of this standard.

– 6 – 60601-2-21 © IEC:2009
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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 standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
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;
– 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.
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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

60601-2-21 © IEC:2009 – 7 –
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 and IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively.
IEC 60601-1-3 does 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
EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not

– 8 – 60601-2-21 © IEC:2009
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
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
NOTE Informative references are listed in the bibliography beginning on page 32.
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard
apply, except as follows:
NOTE An index of defined terms is found beginning on page 34.
Addition:
201.3.201
BABY CONTROLLED RADIANT WARMER
mode of operation in which the power output varies automatically in order to maintain the
SKIN TEMPERATURE SENSOR according to the CONTROL
temperature as measured by a
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
60601-2-21 © IEC:2009 – 9 –
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)

C
D
M
A
B
IEC  255/09
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
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)

– 10 – 60601-2-21 © IEC:2009
Dimensions in millimeters
50 ± 2
∅100 ± 2
IEC  372/09
Key
1 = Mattress
Surface finish: non-reflective black paint
Disc mass 500 g ± 10 g
3 3
Disc material: aluminum 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 T is expressed in °C.
M
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 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 particular standard 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 subclause 201.15.4.2.1 of the
relevant particular standards (e.g. IEC 60601-2-19 etc).
201.4.3 ESSENTIAL PERFORMANCE
Addition:
23 ± 1
∅5 max.
60601-2-21 © IEC:2009 – 11 –
*
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 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 standard 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 particular standard, 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:
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".

– 12 – 60601-2-21 © IEC:2009
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;
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);
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;

60601-2-21 © IEC:2009 – 13 –
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 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.
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
201.7.9.3.1 General
Additional item:
– 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:
– 14 – 60601-2-21 © IEC:2009
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 dBA at a distance of 3 m from
the front of the INFANT RADIANT WARMER. 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 dBA.
The sound pressure level of the ALARM SIGNAL shall not exceed 80 dBA 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 dBA below the measured
levels.
201.9.8 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, e.g. 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

60601-2-21 © IEC:2009 – 15 –
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:
in the
The maximum irradiance level at any point on the mattress shall not exceed 60 mW/cm
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 NORNAL 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.

– 16 – 60601-2-21 © IEC:2009
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 EQUIPEMENT 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 SYST
...