EN ISO 11979-4:2008/A1:2012

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)

2012-03-28 EMA: Draft for // vote received in ISO/CS (see notification of 2012-03-27 in dataservice).
2011-05-31 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-05-30 in dataservice).

Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information - Änderung 1 (ISO 11979-4:2008/Amd 1:2012)

Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations - Amendement 1 (ISO 11979-4:2008/Amd 1:2012)

Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije - Dopolnilo A1 (ISO 11979-4:2008/Amd 1:2012)

Ta del standarda ISO 11979 določa zahteve za označevanje intraokularnih leč (IOL) in informacije, ki morajo biti priložene embalaži ali biti natisnjene na embalaži.

General Information

• Status: Published
• Publication Date: 30-Sep-2012
• Withdrawal Date: 29-Apr-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Oct-2012
• Completion Date: 01-Oct-2012
• Ref Project: SIST EN ISO 11979-4:2009/A1:2013 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)

Relations

• Amends: EN ISO 11979-4:2008 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
• Effective Date: 06-Mar-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-4:2009/A1:2013
01-januar-2013
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO2]QDþHYDQMHLQLQIRUPDFLMH
'RSROQLOR$,62$PG
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment
1 (ISO 11979-4:2008/Amd 1:2012)
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information -
Änderung 1 (ISO 11979-4:2008/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations -
Amendement 1 (ISO 11979-4:2008/Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 11979-4:2008/A1:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-4:2009/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-4:2009/A1:2013

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SIST EN ISO 11979-4:2009/A1:2013


EUROPEAN STANDARD
EN ISO 11979-4:2008/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and
information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Ophthalmische Implantate - Intraokularlinsen - Teil 4:
Étiquetage et informations - Amendement 1 (ISO 11979- Etikettierung und Information - Änderung 1 (ISO 11979-
4:2008/Amd 1:2012) 4:2008/Amd 1:2012)
This amendment A1 modifies the European Standard EN ISO 11979-4:2008; it was approved by CEN on 29 August 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-4:2008/A1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11979-4:2009/A1:2013
EN ISO 11979-4:2008/A1:2012 (E)
Contents Page
Foreword .3

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SIST EN ISO 11979-4:2009/A1:2013
EN ISO 11979-4:2008/A1:2012 (E)
Foreword
This document (EN ISO 11979-4:2008/A1:2012) 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 11979:2008 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and
conflicting national standards shall be withdrawn at the latest by April 2013.
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 organisations 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 11979-4:2008/Amd 1:2012 has been approved by CEN as a EN ISO 11979-4:2008/A1:2012
without any modification.

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