SIST EN 60601-2-20:2010
(Main)Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (IEC 60601-2-20:2009)
Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (IEC 60601-2-20:2009)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, 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 safety requirements for INFANT TRANSPORT INCUBATORS 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 [1]1);
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschlißlich der wesentlichen Leistungsmerkmale von Transportinkubatoren (IEC 60601-2-20:2009)
Appareils électromédicaux - Partie 2-20: Règles particulières de sécurité de base et de performances essentielles des incubateurs de transport (CEI 60601-2-20:2009)
La CEI 60601-2-20:2009 spécifie les exigences de sécurité relatives aux incubateurs de transport 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 de la CEI 60601-2-20 parue en 1990 et son Amendement 1 (1996). Cette édition constitue une révision technique. La présente édition de la CEI 60601 2-20 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1. Le contenu du corrigendum de février 2012 a été pris en considération dans cet exemplaire.
Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in bistvene lastnosti prenosnih inkubatorjev (IEC 60601-2-20:2009)
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI opreme PRENOSNIH INKUBATORJEV ZA DOJENČKE, kot so opredeljene v točki 201.3.211 tega standarda, imenovano tudi ME OPREMA. Če je klavzula ali podklavzula izrecno namenjena uporabi zgolj za ME OPREMO ali ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to navedla. Če ni tako, se klavzula ali podklavzula smotrno uporablja tako za ME OPREMO kot ME SISTEME. NEVARNOSTI, ki so v okviru tega standarda povezane s predvideno fiziološko funkcijo ME OPREME ali ME SISTEMOV, niso zajete v posebnih zahtevah tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda. Ta posebni standard opredeljuje varnostne zahteva za PRENOSNE INKUBATORJE ZA DOJENČKE, vendar za nadomestne metode ugotavljanja skladnosti s posebno klavzulo z dokazovanjem enake stopnje varnosti ne velja, da niso skladne, če je PROIZVAJALEC dokazal v svojem DOKUMENTU O OBVLADOVANJU TVEGANJA, da je bilo za TVEGANJE, ki ga predstavljajo NEVARNOSTI, ugotovljeno, da ni na sprejemljivi ravni v primerjavi z koristjo zdravljenja, ki ga zagotavlja naprava.
Ta posebni standard ne velja za:
– naprave, ki oddajajo toploto v medicinske namene preko ODEJ, BLAZIN ali ŽIMNIC; za informacije glej IEC 80601-2-35 [1];
– INKUBATORJE ZA DOJENČKE, ki niso PRENOSNI INKUBATORJI ZA DOJENČKE; za informacije glej IEC 60601-2-19 [2];
– SEVALNE GRELNIKE ZA DOJENČKE; za informacije glej IEC 60601-2-21 [3];
– FOTOTERAPIJO ZA DOJENČKE; za informacije glej IEC 60601-2-50 [4].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-20:2010
01-januar-2010
1DGRPHãþD
SIST EN 60601-2-20:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLSUHQRVQLKLQNXEDWRUMHY ,(&
Medical electrical equipment - Part 2-20: Particular requirements for basic safety and
essential performance of transport incubators (IEC 60601-2-20:2009)
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit
einschlißlich der wesentlichen Leistungsmerkmale von Transportinkubatoren (IEC 60601
-2-20:2009)
Appareils électromédicaux - Partie 2-20: Règles particulières de sécurité de base et de
performances essentielles des incubateurs de transport (CEI 60601-2-20:2009)
Ta slovenski standard je istoveten z: EN 60601-2-20:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 60601-2-20:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-20:2010
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SIST EN 60601-2-20:2010
EUROPEAN STANDARD
EN 60601-2-20
NORME EUROPÉENNE
November 2009
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 60601-2-20:1996
English version
Medical electrical equipment -
Part 2-20: Particular requirements for the basic safety
and essential performance of infant transport incubators
(IEC 60601-2-20:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-20: Exigences particulières Teil 2-20: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des incubateurs de transport von Tranportinkubatoren
pour nouveau-nés (IEC 60601-2-20:2009)
(CEI 60601-2-20:2009)
This European Standard was approved by CENELEC on 2009-09-01. 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 60601-2-20:2009 E
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SIST EN 60601-2-20:2010
EN 60601-2-20:2009 - 2 -
Foreword
The text of document 62D/731/FDIS, future edition 2 of IEC 60601-2-20, 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 60601-2-20 on 2009-09-01.
This European Standard supersedes EN 60601-2-20:1996.
EN 60601-2-20:1996 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) 2010-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-09-01
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
– “claus
...
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