SIST EN ISO 11979-9:2006/A1:2014

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006/Amd 1:2014)

This part of ISO 11979 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near). NOTE The term “near vision” as used in this part of ISO 11979 includes useful vision at a distance of claimed benefit; e.g. near and/or intermediate distances.

Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale Intraokularlinsen (ISO 11979-9:2006/Amd 1:2014)

N/A

Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Lentilles intraoculaires multifocales (ISO 11979-9:2006/Amd 1:2014)

Očesni vsadki (implantati) - Intraokularne leče - 9. del: Večgoriščna intraokularna stekla (ISO 11979-9:2006/Amd 1:2014)

Ta del standarda ISO 11979 se uporablja za katero koli intraokularno lečo z optiko, ki zagotavlja dve ali več rotacijsko simetričnih dioptrij, pri čemer je leča primarno namenjena korekciji afakije z dodano koristjo uporabnega vida na več razdaljah, ne le na eni (npr. na daleč in blizu). OPOMBA: Izraz »vid na blizu«, kot se uporablja v tem delu standarda ISO 11979, zajema uporabni vid na razdalji navedene koristi; npr. na blizu in/ali na vmesne razdalje.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 29-Sep-2013
• Publication Date: 13-Oct-2014
• Withdrawal Date: 06-Jun-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Jun-2018
• Due Date: 30-Jun-2018
• Completion Date: 07-Jun-2018
• Ref Project: EN ISO 11979-9:2006/A1:2014 - Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006/Amd 1:2014)

Relations

• Amends: SIST EN ISO 11979-9:2006 - Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006)
• Effective Date: 01-Nov-2014
• Replaced By: SIST EN ISO 11979-7:2018 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
• Effective Date: 01-Jul-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-9:2006/A1:2014
01-november-2014
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO9HþJRULãþQDLQWUDRNXODUQD
VWHNOD,62$PG
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO
11979-9:2006/Amd 1:2014)
Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale Intraokularlinsen (ISO
11979-9:2006/Amd 1:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Lentilles intraoculaires
multifocales (ISO 11979-9:2006/Amd 1:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-9:2006/A1:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-9:2006/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-9:2006/A1:2014

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SIST EN ISO 11979-9:2006/A1:2014

EUROPEAN STANDARD
EN ISO 11979-9:2006/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2014
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal
intraocular lenses (ISO 11979-9:2006/Amd 1:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Ophthalmische Implantate - Intraokularlinsen - Teil 9:
Lentilles intraoculaires multifocales (ISO 11979-9:2006/Amd Multifokale Intraokularlinsen (ISO 11979-9:2006/Amd
1:2014) 1:2014)
This amendment A1 modifies the European Standard EN ISO 11979-9:2006; it was approved by CEN on 18 July 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 CEN 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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-9:2006/A1:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11979-9:2006/A1:2014
EN ISO 11979-9:2006/A1:2014 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11979-9:2006/A1:2014
EN ISO 11979-9:2006/A1:2014 (E)
Foreword
This document (EN ISO 11979-9:2006/A1:2014) has been prepared by Technical Committee ISO/TC 172
“Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 11979-9:2006 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by February 2015, and
conflicting national standards shall be withdrawn at the latest by February 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-9:2006/Amd, 1:2014 has been approved by CEN as EN ISO 11979-9:2006/A1:2014
without any modification.

3

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...

SLOVENSKI STANDARD
SIST EN ISO 11979-9:2006/oprA1:2013
01-september-2013
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO9HþJRULãþQDLQWUDRNXODUQD
VWHNOD,62'$0
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO
11979-9:2006/DAM 1:2013)
Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale Intraokularlinsen (ISO
11979-9:2006/DAM 1:2013)
Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Lentilles intraoculaires
multifocales (ISO 11979-9:2006/DAM 1:2013)
Ta slovenski standard je istoveten z: EN ISO 11979-9:2006/prA1
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-9:2006/oprA1:2013 de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11979-9:2006/oprA1:2013

---------------------- Page: 2 ----------------------
SIST EN ISO 11979-9:2006/oprA1:2013


EUROPÄISCHE NORM
ENTWURF
EN ISO 11979-9:2006
EUROPEAN STANDARD

NORME EUROPÉENNE
prA1
Mai 2013
ICS 11.040.70
Deutsche Fassung
Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale
Intraokularlinsen (ISO 11979-9:2006/DAM 1:2013)
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal Implants ophtalmiques - Lentilles intraoculaires - Partie 9:
intraocular lenses (ISO 11979-9:2006/DAM 1:2013) Lentilles intraoculaires multifocales (ISO 11979-
9:2006/DAM 1:2013)
Dieser Änderungs-Entwurf wird den CEN-Mitgliedern zur parallelen Umfrage vorgelegt. Er wurde vom Technischen Komitee CEN/TC 170
erstellt.

Dieser Entwurf für eine Änderung A1 wird, wenn er angenommen ist, die Europäische Norm EN ISO 11979-9:2006 modifizieren. Wenn aus
diesem Änderungs-Entwurf eine Änderung wird, sind die CEN-Mitglieder gehalten, die CEN-Geschäftsordnung zu erfüllen, in der die
Bedingungen festgelegt sind, unter denen diese Änderung in der betreffenden nationalen Norm, ohne jede Änderung, einzufügen ist.

Dieser Änderungs-Entwurf wurde vom CEN in drei offiziellen Fassungen (Deutsch, Englisch, Französisch) erstellt. Eine Fassung in einer
anderen Sprache, die von einem CEN-Mitglied in eigener Verantwortung durch Übersetzung in seine Landessprache gemacht und dem
Management-Zentrum des CEN-CENELEC mitgeteilt worden ist, hat den gleichen Status wie die offiziellen

CEN-Mitglieder sind die nationalen Normungsinstitute von Belgien, Bulgarien, Dänemark, Deutschland, der ehemaligen jugoslawischen
Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland, Irland, Island, Italien, Kroatien, Lettland, Litauen, Luxemburg, Malta,
den Niederlanden, Norwegen, Österreich, Polen, Portugal, Rumänien, Schweden, der Schweiz, der Slowakei, Slowenien, Spanien, der
Tschechischen Republik, der Türkei, Ungarn, dem Vereinigten Königreich und Zypern.

Die Empfänger dieses Norm-Entwurfs werden gebeten, mit ihren Kommentaren jegliche relevante Patentrechte, die sie kennen, mitzu
...