EN ISO 11979-8:2015

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)

11979-8:2006 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2006 + Amd 1:2011)

Dieser Teil von ISO 11979 legt grundlegende Anforderungen an Intraokularlinsen fest, die für die Implantation
in den vorderen Abschnitt des menschlichen Auges vorgesehen sind, mit Ausnahme von Implantaten und
Transplantaten für die Hornhaut.

Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales (ISO 11979-8:2006 + Amd 1:2011)

L'ISO 11979-8:2006 spécifie les exigences fondamentales applicables à tous les types de lentilles intraoculaires destinées à l'implantation chirurgicale dans le segment antérieur de l'oeil humain, à l'exception des implants et transplants cornéens.

Očesni vsadki (implantati) - Intraokularne leče - 8. del: Temeljne zahteve (ISO 11979-8:2006 + Amd 1:2011)

Določa temeljne zahteve za vse vrste intraokularnih leč, namenjenih za kirurško vsaditev v sprednji segment človeškega očesa, razen roženičnih vsadkov in presadkov.

General Information

• Status: Withdrawn
• Publication Date: 27-Jan-2015
• Withdrawal Date: 09-May-2017
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 10-May-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11979-8:2015 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)

Relations

• Replaces: EN ISO 11979-8:2009/A1:2011 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)
• Effective Date: 04-Feb-2015
• Replaces: EN ISO 11979-8:2009 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
• Effective Date: 04-Feb-2015
• Replaced By: EN ISO 11979-8:2017 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
• Effective Date: 08-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-8:2015
01-maj-2015
1DGRPHãþD
SIST EN ISO 11979-8:2009
SIST EN ISO 11979-8:2009/A1:2011
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO7HPHOMQH]DKWHYH,62
$PG
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979
-8:2006 + Amd 1:2011)
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO
11979-8:2006 + Amd 1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales
(ISO 11979-8:2006 + Amd 1:2011)
Ta slovenski standard je istoveten z: EN ISO 11979-8:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-8:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-8:2015

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SIST EN ISO 11979-8:2015

EUROPEAN STANDARD
EN ISO 11979-8

NORME EUROPÉENNE

EUROPÄISCHE NORM
January 2015
ICS 11.040.70 Supersedes EN ISO 11979-8:2009
English Version
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental
requirements (ISO 11979-8:2006 + Amd 1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Ophthalmische Implantate - Intraokularlinsen - Teil 8:
Exigences fondamentales (ISO 11979-8:2006 + Amd Grundlegende Anforderungen (ISO 11979-8:2006 + Amd
1:2011) 1:2011)
This European Standard was approved by CEN on 7 January 2015.

CEN 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 CEN 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 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-8:2015 E
worldwide for CEN national Members.

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SIST EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5

2

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SIST EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Foreword
The text of ISO 11979-8:2006 + Amd 1:2011 has been prepared by Technical Committee ISO/TC 172 “Optics
and photonics” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 11979-8:2015 by Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by July 2015, and conflicting national standards shall be withdrawn at the
latest by July 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.
This document supersedes EN ISO 11979-8:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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 R
...