SIST EN IEC 60601-2-19:2021
(Main)Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2020)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2020)
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, 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.
Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren (IEC 60601-2-19:2020)
Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés (IEC 60601-2-19:2020)
IEC 60601-2-19:2020 est disponible sous forme de IEC 60601-2-19:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških inkubatorjev (IEC 60601-2-19:2020)
Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKIH INKUBATORJEV, kot je določeno v točki 201.3.209, imenovanih tudi ELEKTROMEDICINSKA OPREMA.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-19:2021
01-september-2021
Nadomešča:
SIST EN 60601-2-19:2009
SIST EN 60601-2-19:2009/A1:2017
SIST EN 60601-2-19:2009/A11:2012
Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških inkubatorjev (IEC 60601-2-19:2020)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and
essential performance of infant incubators (IEC 60601-2-19:2020)
Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren (IEC
60601-2-19:2020)
Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs pour nouveau-nés (IEC 60601-2-
19:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-19:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN IEC 60601-2-19:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-19:2021
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SIST EN IEC 60601-2-19:2021
EUROPEAN STANDARD EN IEC 60601-2-19
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.10 Supersedes EN 60601-2-19:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-19: Particular requirements
for the basic safety and essential performance of infant
incubators
(IEC 60601-2-19:2020)
Appareils électromédicaux - Partie 2-19: Exigences Medizinische elektrische Geräte - Teil 2-19: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs pour nouveau-nés wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
(IEC 60601-2-19:2020) (IEC 60601-2-19:2020)
This European Standard was approved by CENELEC on 2020-10-07. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-19:2021 E
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SIST EN IEC 60601-2-19:2021
EN IEC 60601-2-19:2021 (E)
European foreword
The text of document 62D/1764/FDIS, future edition 3 of IEC 60601-2-19, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-19:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 60601-2-19:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-19:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for
...
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