EN 80601-2-58:2015/A1:2019

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 80601-2-58:2014 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, hereafter referred to as ME equipment. 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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this 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

L'IEC 80601-2-58:2014 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 des accessoires liés qui peuvent être raccordés à ces appareils électromédicaux, désignés ci-après comme appareils EM. Les dangers inhérents à la fonction physiologique prévue de l'appareil EM ou des systèmes EM dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 7.2.13 et 8.4.1 de la norme générale. Cette seconde édition contient des changements permettant de prendre en compte les commentaires soumis durant l'approbation de la première édition en tant que Directive Médicale Européenne, ainsi que des commentaires d'autre Comités Nationaux soumis lors de la finalisation de la première édition de cette norme.

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 - Dopolnilo A1 (IEC 80601-2-58:2014/A1:2016)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV
ZA ODSTRANJEVANJE LEČ in NAPRAV ZA VITREKTOMIJO za očesno operacijo (kot je opredeljeno v poglavjih 201.3.208
in 201.3.217) ter povezanih DODATKOV, ki jih je mogoče priključiti na to MEDICINSKO ELEKTRIČNO OPREMO, v nadaljevanju: ME OPREMA. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda.

General Information

• Status: Published
• Publication Date: 22-Aug-2019
• Withdrawal Date: 22-Aug-2022
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Aug-2019
• Completion Date: 23-Aug-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 80601-2-58:2015/A1:2019 - 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 80601-2-58:2014/A1:2016)

Relations

• Amends: 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: 16-Jun-2015
• Revised: FprEN IEC 80601-2-58:2023 - 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: 05-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-58:2015/A1:2019
01-november-2019
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 - Dopolnilo A1 (IEC 80601-2-58:2014/A1:2016)
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 80601-2-58:2014/A1:2016)
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 80601-2-58:2014/A1:2016)
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 (IEC 80601-2-58:2014/A1:2016)
Ta slovenski standard je istoveten z: EN 80601-2-58:2015/A1:2019
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2015/A1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 80601-2-58:2015/A1:2019

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SIST EN 80601-2-58:2015/A1:2019


EUROPEAN STANDARD EN 80601-2-58:2015/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2019
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 80601-2-58:2014/A1:2016)
Appareils électromédicaux - Partie 2-58: Exigences Medizinische elektrische Geräte - Teil 2-58: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs de retrait du cristallin et des wesentlichen Leistungsmerkmale für Geräte zur
dispositifs de vitrectomie pour la chirurgie ophtalmique Linsenentfernung und Geräte zur Glaskörperentfernung in
(IEC 80601-2-58:2014/A1:2016) der Augenchirurgie
(IEC 80601-2-58:2014/A1:2016)
This amendment A1 modifies the European Standard EN 80601-2-58:2015; it was approved by CENELEC on 2019-08-07. 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.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 80601-2-58:2015/A1:2019 E

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SIST EN 80601-2-58:2015/A1:2019
EN 80601-2-58:2015/A1:2019 (E)
European foreword
The text of document 62D/1364/FDIS, future IEC 80601-2-58:2014/A1, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-58:2015/A1:2019.
The following dates are fixed:
(dop) 2020-02-23
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with (dow) 2022-08-23
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade
...