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

IEC 80601-2-58:2008 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment.

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

La CEI 80601-2-58:2008 s'applique à la sécurité de base et aux performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique et les accessoires liés qui peuvent être raccordés à ces appareils électromédicaux.

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 (IEC 80601-2-58:2008)

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• Status: Withdrawn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: 05-Feb-2009
• Withdrawal Date: 31-Jan-2012
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• 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
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 80601-2-58:2009 - Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2008)

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: 28-Jan-2023
• Amended By: EN 80601-2-58:2009/A11:2011 - 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-58:2009
01-april-2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DRGVWUDQMHYDQMHOHþLQQDSUDY]DYLWUHNWRPLMRSULRþHVQL
NLUXUJLML,(&
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and
essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery (IEC 80601-2-58:2008)
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 (IEC 80601-2-58:2008)
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 (CEI 80601-2-58:2008)
Ta slovenski standard je istoveten z: EN 80601-2-58:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN 80601-2-58

NORME EUROPÉENNE
February 2009
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
(IEC 80601-2-58:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-58: Exigences particulières Teil 2-58: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des dispositifs de retrait du cristallin für Geräte zur Linsenentfernung
et des dispositifs de vitrectomie und Geräte zur Glaskörperentfernung
pour la chirurgie ophtalmique in der Augenchirurgie
(CEI 80601-2-58:2008) (IEC 80601-2-58:2008)




This European Standard was approved by CENELEC on 2009-02-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: avenue Marnix 17, B - 1000 Brussels


© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 80601-2-58:2009 E

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EN 80601-2-58:2009 - 2 -
Foreword
The text of document 62D/701/FDIS, future edition 1 of IEC 80601-2-58, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 7, Ophthalmic
optics and instruments, of ISO TC 172, Optics and photonics, was submitted to the IEC-CENELEC
parallel vote and was approved by CENELEC as EN 80601-2-58 on 2009-02-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2009-11-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2012-02-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PART
...