SIST EN 60601-2-19:2009/A11:2012
(Amendment)Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 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 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 [3]2);
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1];
– INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4].
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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