Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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

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.

General Information

Status
Published
Publication Date
28-Sep-2020
Current Stage
PPUB - Publication issued
Completion Date
29-Sep-2020
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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
IEC 60601-2-21:2020-09(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
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
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.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
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
---------------------- Page: 11 ----------------------
– 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

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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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 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:
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– 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
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