EN ISO 11979-8:2009/A1:2011

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

2012-06-15 ST status quo for citation - OJ flag removed
2010-10-20 EMA: // final draft provided to ISO/CS according to notification received in dataservice on 2010-10-19.

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

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

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

Ta del ISO 11979 določa temeljne zahteve za vse vrste intraokularnih leč za kirurško implantacijo v sprednji del človeškega očesa, pri čemer so izključeni vsadki roženice in transplantati.

General Information

• Status: Withdrawn
• Publication Date: 14-May-2011
• Withdrawal Date: 27-Jan-2015
• 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: 28-Jan-2015
• 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
• Mandate: M/382 - Mandate for standardisation addressed to CEN in the field of Methods of analysis for animal Feedingstuffs
• Ref Project: SIST EN ISO 11979-8:2009/A1:2011 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)

Relations

• Replaced By: EN ISO 11979-8:2015 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
• Effective Date: 04-Feb-2015
• Amends: EN ISO 11979-8:2009 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

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

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SIST EN ISO 11979-8:2009/A1:2011

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SIST EN ISO 11979-8:2009/A1:2011


EUROPEAN STANDARD
EN ISO 11979-8:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2011
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental
requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Ophthalmische Implantate - Intraokularlinsen - Teil 8:
Exigences fondamentales - Amendement 1 (ISO 11979- Grundlegende Anforderungen - Änderung 1 (ISO 11979-
8:2006/Amd 1:2011) 8:2006/Amd 1:2011)
This amendment A1 modifies the European Standard EN ISO 11979-8:2009; it was approved by CEN on 14 May 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-8:2009/A1:2011: E
worldwide for CEN national Members.

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SIST EN ISO 11979-8:2009/A1:2011
EN ISO 11979-8:2009/A1:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (Medical Device Directive) .4

2

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SIST EN ISO 11979-8:2009/A1:2011
EN ISO 11979-8:2009/A1:2011 (E)
Foreword
This document (EN ISO 11979-8:2009/A1:2011) 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 shall be given the status of a national standard, either by
publication of an identical text or by endorsement, at the latest by November 2011, and conflicting national
standards shall be withdrawn at the latest by November 2011.
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 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 93/42/EEC, as
amended by Directive 2007/47/EC.
For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, 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
...