SIST EN 80601-2-58:2009/A11:2012
(Amendment)Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter 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.
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und Geräte zur Glaskörperentfernung in der Augenchirurgie
Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique
Medicinska električna oprema - 2-58. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za odstranjevanje leč in naprav za vitrektomijo pri očesni kirurgiji
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV ZA ODSTRANJEVANJE LEČ in NAPRAV ZA VITREKTOMIJO pri očesni kirurgiji (kot je določeno v 201.3.208 in 201.3.217) in povezane DODATKE, ki so lahko povezani s to MEDICINSKO ELEKTRIČNO OPREMO, v nadaljevanju 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.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 80601-2-58:2009/A11:2012
01-januar-2012
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ELVWYHQHODVWQRVWLQDSUDY]DRGVWUDQMHYDQMHOHþLQQDSUDY]DYLWUHNWRPLMRSULRþHVQL
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Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and
essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und
Geräte zur Glaskörperentfernung in der Augenchirurgie
Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de
vitrectomie pour la chirurgie ophtalmique
Ta slovenski standard je istoveten z: EN 80601-2-58:2009/A11:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2009/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 80601-2-58:2009/A11:2012
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SIST EN 80601-2-58:2009/A11:2012
EUROPEAN STANDARD
EN 80601-2-58/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040.70
English version
Medical electrical equipment -
Part 2-58: Particular requirements for the basic safety and essential
performance of lens removal devices and vitrectomy devices for
ophthalmic surgery
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-58: Exigences particulières pour Teil 2-58: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des dispositifs de retrait du Leistungsmerkmale für Geräte zur
cristallin et des dispositifs de vitrectomie Linsenentfernung und Geräte zur
pour la chirurgie ophtalmique Glaskörperentfernung in der
Augenchirurgie
This amendment A11 modifies the European Standard EN 80601-2-58:2009; 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 tra
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