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

IEC 60601-2-21:2009 specifies the safety requirements for infant radiant warmers. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 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.

Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern

Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés

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
19-May-2009
Withdrawal Date
31-Mar-2012
Current Stage
6060 - Document made available - Publishing
Start Date
20-May-2009
Completion Date
20-May-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.

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SIST EN 60601-2-21:2009

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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

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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
...

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