EN 60601-2-19:2009/A11:2011

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-19:2009
2021: CLC legacy converted by DCLab NISOSTS

Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren

Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés

Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških inkubatorjev

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKIH INKUBATORJEV, kot je določeno v 201.3.209 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 INKUBATORJE, 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 toploto prek ODEJ, BLAZIN ali POSTELJNIH VLOŽKOV pri medicinski uporabi; za informacije
glej IEC 80601-2-35 [3]2;
- OTROŠKE SEVALNE OGREVALNIKE; za informacije glej IEC 60601-2-21 [2];
- PRENOSNE INKUBATORJE; za informacije glej IEC 60601-2-20 [1];
- OPREMO ZA FOTOTERAPIJO DOJENČKOV; za informacije glej IEC 60601-2-50 [4].

General Information

• Status: Published
• Publication Date: 13-Oct-2011
• Withdrawal Date: 30-Sep-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 14-Oct-2011
• Completion Date: 14-Oct-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-2-19:2009/A11:2012 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Relations

• Replaced By: EN IEC 60601-2-19:2021 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
• Effective Date: 20-Jul-2021
• Amends: EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
• Effective Date: 28-Jan-2023
• Revised: EN 60601-2-19:2009/A1:2016 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
• Effective Date: 03-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-19:2009/A11:2012
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRWURãNLKLQNXEDWRUMHY
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and
essential performance of infant incubators
Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-19:2009/A11:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 60601-2-19:2009/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-19:2009/A11:2012

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SIST EN 60601-2-19:2009/A11:2012

EUROPEAN STANDARD
EN 60601-2-19/A11

NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM

ICS 11.040.10


English version


Medical electrical equipment -
Part 2-19: Particular requirements for the basic safety and essential
performance of infant incubators



Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-19: Exigences particulières pour Teil 2-19: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des incubateurs pour Leistungsmerkmale von
nouveau-nés Säuglingsinkubatoren






This amendment A11 modifies the European Standard EN 60601-2-19:2009; it was approved by CENELEC on
2011-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 amendment 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.

CENELE
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