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- Withdrawn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
- 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
Relations
- Effective Date
- 29-Jan-2023
- Effective Date
- 29-Jan-2023
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Frequently Asked Questions
EN 80601-2-58:2009/A11:2011 is a amendment published by CLC. Its full title is "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 standard covers: D139/C149: BT approved the modified Annex ZZ for EN 80601-2-58:2009
D139/C149: BT approved the modified Annex ZZ for EN 80601-2-58:2009
EN 80601-2-58:2009/A11:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 80601-2-58:2009/A11:2011 has the following relationships with other standards: It is inter standard links to EN 80601-2-58:2015, EN 80601-2-58:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 80601-2-58:2009/A11:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 80601-2-58:2009/A11:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
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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