Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)

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.

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)

La CEI 60601-2-21:2009 spécifie les exigences de sécurité relatives aux incubateurs radiants pour nouveau-nés. La présente norme particulière modifie et complète la CEI 60601-1:2005, Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette deuxième édition annule et remplace la première édition parue en 1994 et son Amendement 1 (1996). Cette édition constitue une révision technique. La présente édition de la CEI 60601 2-21 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1.

Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških sevalnih ogrevalnikov (IEC 60601-2-21:2009)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKIH SEVALNIH OGREVALNIKOV, kot je določeno v 201.3.204 tega standarda, prav tako imenovanih ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Prav tako glej 4.2 splošnega standarda. Ta določen standard določa varnostne zahteve za OTROŠKE SEVALNE OGREVALNIKE, vendar alternativne metode skladnosti z določeno točko z dokazovanjem enakovredne varnosti ne bodo ocenjene kot neskladne, če je PROIZVAJALEC predstavil v svojem DOKUMENTU OBVLADOVANJA TVEGANJA, da je TVEGANJE, predstavljeno z NEVARNOSTJO, sprejemljive stopnje v primerjavi s koristjo terapije naprave. Ta konkretni standard ne velja za: - naprave, ki dovajajo toplote prek ODEJ, BLAZIN ali POSTELJNIH VLOŽKOV pri medicinski uporabi; za informacije, glej IEC 80601-2-35; - OTROŠKE INKUBATORJE; za informacije glej IEC 60601-2-19; - PRENOSNE INKUBATORJE; za informacije glej IEC 60601-2-20;
- OPREMO ZA FOTOTERAPIJO DOJENČKOV; za informacije glej IEC 60601-2-50.

General Information

Status
Published
Publication Date
10-Jun-2009
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-May-2009
Due Date
01-Aug-2009
Completion Date
11-Jun-2009

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SLOVENSKI STANDARD
SIST EN 60601-2-21:2009
01-julij-2009
1DGRPHãþD
SIST EN 60601-2-21:1995
SIST EN 60601-2-21:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRWURãNLKVHYDOQLKRJUHYDOQLNRY ,(&

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
SIST EN 60601-2-21:2009 en,fr

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-21:2009
---------------------- Page: 2 ----------------------
SIST EN 60601-2-21:2009
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
---------------------- Page: 3 ----------------------
SIST EN 60601-2-21:2009
EN 60601-2-21:2009 - 2 -
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.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-21:2009
- 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).
__________
---------------------- Page: 5 ----------------------
SIST EN 60601-2-21:2009
EN 60601-2-21:2009 - 4 -
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
---------------------- Page: 6 ----------------------
SIST EN 60601-2-21:2009
- 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.
___________
---------------------- Page: 7 ----------------------
SIST EN 60601-2-21:2009
---------------------- Page: 8 ----------------------
SIST EN 60601-2-21:2009
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
CODE PRIX
ICS 11.040.10 ISBN 2-8318-1032-9
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 9 ----------------------
SIST EN 60601-2-21:2009
– 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

---------------------- Page: 10 ----------------------
SIST EN 60601-2-21:2009
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.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-21:2009
– 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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-21:2009
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.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-21:2009
– 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
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.
—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-21:2009
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

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SIST EN 60601-2-21:2009
– 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
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SIST EN 60601-2-21:2009
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

TEST DEVICE AVERAGE TEMPERATURE of the TEST DEVICE positioned at the mid-point of the

INFANT RADIANT WARMER mattress (See Figure 201.101)
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 WA
...

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