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 - Predlagani horizontalni standardi

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
28-May-2015
Withdrawal Date
28-May-2018
Current Stage
6060 - Document made available - Publishing
Start Date
29-May-2015
Completion Date
29-May-2015

Relations

Buy Standard

Standard
EN 80601-2-58:2015
English language
31 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-58:2015
01-september-2015
1DGRPHãþD
SIST EN 80601-2-58:2009
SIST EN 80601-2-58:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DRGVWUDQMHYDQMHOHþLQQDSUDY]DYLWUHNWRPLMRSULRþHVQL
NLUXUJLML3UHGODJDQLKRUL]RQWDOQLVWDQGDUGL
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 - Proposed Horizontal Standards
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 - Normes horizontales suggérées
Ta slovenski standard je istoveten z: EN 80601-2-58:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 80601-2-58:2015

---------------------- Page: 2 ----------------------

SIST EN 80601-2-58:2015


EUROPEAN STANDARD EN 80601-2-58

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.70 Supersedes EN 80601-2-58:2009
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)
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) der Augenchirurgie
(IEC 80601-2-58:2014)
This European Standard was approved by CENELEC on 2014-10-09. 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 CEN-CENELEC
Management Centre 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 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 80601-2-58:2015 E

---------------------- Page: 3 ----------------------

SIST EN 80601-2-58:2015
EN 80601-2-58:2015
Foreword
The text of document 62D/1151/FDIS, future edition 2 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 approved by CENELEC as EN 80601-2-58:2015.


The following dates are fixed:
(dop) 2015-11-29
• 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 (dow) 2018-05-29
standards conflicting with the
document have to be withdrawn

This document supersedes EN 80601-2-58:2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate give
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.