SIST EN IEC 60601-2-21:2021
(Main)Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020)
EN-IEC 60601-2-21 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.
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC 60601-2-21:2020)
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés (IEC 60601-2-21:2020)
IEC 60601-2-21:2020 est disponible sous forme de IEC 60601-2-21:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
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.
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških sevalnih ogrevalnikov (IEC 60601-2-21:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-21:2021
01-september-2021
Nadomešča:
SIST EN 60601-2-21:2009
SIST EN 60601-2-21:2009/A1:2017
SIST EN 60601-2-21:2009/A11:2012
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških sevalnih ogrevalnikov (IEC 60601-2-21:2020)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers (IEC 60601-2-21:2020)
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC
60601-2-21:2020)
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs radiants pour nouveau-nés (IEC 60601
-2-21:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-21:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN IEC 60601-2-21:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-21:2021
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SIST EN IEC 60601-2-21:2021
EUROPEAN STANDARD EN IEC 60601-2-21
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.10 Supersedes EN 60601-2-21:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-21: Particular requirements
for the basic safety and essential performance of infant radiant
warmers
(IEC 60601-2-21:2020)
Appareils électromédicaux - Partie 2-21: Exigences Medizinische elektrische Geräte - Teil 2-21: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs radiants pour nouveau-nés wesentlichen Leistungsmerkmale von
(IEC 60601-2-21:2020) Säuglingswärmestrahlern
(IEC 60601-2-21:2020)
This European Standard was approved by CENELEC on 2020-11-03. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-21:2021 E
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SIST EN IEC 60601-2-21:2021
EN IEC 60601-2-21:2021 (E)
European foreword
The text of document 62D/1766/FDIS, future edition 3 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 approved by CENELEC as EN IEC 60601-2-21:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 60601-2-21:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-21:2020 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 60601-2-19:2020 NOTE Harmonized as EN IEC 60601-2-19:2020 (not modified)
IEC 60601-2-20:2020 NOTE Harmonized as EN IEC 60601-2-20:2020 (not modified)
IEC 60601-2-35:2020 NOTE Harmonized as EN IEC 80601-2-35:2020 (not modified)
IEC 60601-2-50:2020 NOTE Harmonized as EN IEC 60601-2-50:2020 (not modified)
IEC 61672-1 NOTE Harmonized as EN 61672-1
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007 (not modified)
IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013 (not modified)
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
2
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SIST EN IEC 60601-2-21:2021
EN IEC 60601-2-21:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
3
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SIST EN IEC 60601-2-21:2021
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60601-2-21:2021
– 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
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SIST EN IEC 60601-2-21:2021
IEC 60601-2-21:2020 © IEC 2020 – 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 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.
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– 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.
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IEC 60601-2-21:2020 © IEC 2020 – 5 –
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.
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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.
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SIST EN IEC 60601-2-21:2021
IEC 60601-2-21:2020 © IEC 2020 – 7 –
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 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.
_______________
1
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.
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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.
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IEC 60601-2-21:2020 © IEC 2020 – 9 –
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
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SIST EN IEC 60601-2-21:2021
– 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
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SIST EN IEC 60601-2-21:2021
IEC 60601-2-21:2020 © IEC 2020 – 11 –
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 t
...
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