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EN 80601-2-58:2009/A11:2011

(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

D139/C149: BT approved the modified Annex ZZ for EN 80601-2-58:2009

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.

General Information

Status
Withdrawn
Publication Date
13-Oct-2011
Withdrawal Date
30-Sep-2014
ICS
11.040.70 - Ophthalmic equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
29-May-2018
Completion Date
29-May-2018
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN 80601-2-58:2009/A11:2012 - 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

Relations

Replaced By
EN 80601-2-58:2015 - 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
Effective Date
29-Jan-2023
Amends
EN 80601-2-58:2009 - 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
Effective Date
29-Jan-2023

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EN 80601-2-58:2009/A11:2012EN 80601-2-58:2009/A11:2012
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EN 80601-2-58:2009/A11:2012
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Standards Content (Sample)


SLOVENSKI STANDARD
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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