SIST EN 60601-2-21:2009
(Main)Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
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SIST EN 60601-2-21:1995
SIST EN 60601-2-21:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-2-21
NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 60601-2-21:1994 + A1:1996
English version
Medical electrical equipment -
Part 2-21: Particular requirements
for the basic safety and essential performance
of infant radiant warmers
(IEC 60601-2-21:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-21: Exigences particulières Teil 2-21: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des incubateurs radiants von Säuglingswärmestrahlern
pour nouveau-nés (IEC 60601-2-21:2009)
(CEI 60601-2-21:2009)
This European Standard was approved by CENELEC on 2009-04-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-21:2009 E
Foreword
The text of document 62D/735/FDIS, future edition 2 of IEC 60601-2-21, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-21 on 2009-04-01.
This European Standard supersedes EN 60601-2-21:1994 + A1:1996.
EN 60601-2-21:1994 was revised to structurally align with EN 60601-1:2006.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-04-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
- 3 - EN 60601-2-21:2009
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-21:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335-2-27 NOTE Harmonized as EN 60335-2-27:2003 (not modified).
IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified).
IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified).
IEC 61672-1 NOTE Harmonized as EN 61672-1:2003 (not modified).
ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replace the reference to IEC 60601-1-2 by:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
Standard: Electromagnetic compatibility -
Requirements and tests
Addition:
IEC 60601-1-10 2007 Medical electrical equipment - EN 60601-1-10 2008
Part 1-10: General requirements for basic
safety and essential performance - Collateral
Standard: Requirements for the development
of physiologic closed-loop controllers
- 5 - EN 60601-2-21:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
IEC 60601-2-21 ®
Edition 2.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et les
performances essentielles des incubateurs radiants pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.10 ISBN 2-8318-1032-9
– 2 – 60601-2-21 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.5
201.1 Scope, object and related standards .6
201.2 Normative references .8
201.3 Terms and definitions.8
201.4 General requirements.10
201.5 General requirements for testing of ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.13
201.10 Protection against unwanted and excessive radiation HAZARDS.15
201.11 Protection against excessive temperatures and other HAZARDS.15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.16
201.13 HAZARDOUS SITUATIONS and fault conditions.20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .20
201.15 Construction of ME EQUIPMENT .20
201.16 ME SYSTEMS .22
*
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .22
202 Electromagnetic compatibility – Requirements and tests .22
210 Requirements for the development of physiologic closed-loop controllers .22
Annexes .23
Annex AA (informative) Particular guidance and rationale.24
Bibliography.32
Index of defined terms used in this particular standard.34
Figure 201.101 – Layout of TEST DEVICES .9
Figure 201.102 – TEST DEVICE.10
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements.11
60601-2-21 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinio
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