EN ISO 11979-7:2006

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)

ISO 11979-7:2006 specifies particular requirements for clinical investigations for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.

Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-7:2006)

Dieser Teil von ISO 11979 legt besondere Anforderungen an die klinische Prüfung von monofokalen Hinterkammer- und Vorderkammer-Intraokularlinsen, die zur Korrektur der Aphakie dienen, fest.

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO 11979-7:2006)

L'ISO 11979-7:2006 spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intraoculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.

Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave (ISO 11979-7:2006)

Ta del standarda EN 13503 določa posebne zahteve za protokole kliničnih raziskav za monofokalne intraokularne leče v zadnjem in sprednjem prekatu za korekcijo afakije.
OPOMBA: Katera koli druga vrsta intraokularnih leč, ki ni neposredno zajeta v standardu EN 13503, in katera koli intraokularna leča, v zvezi s katero želi sponzor raziskati trditve, poleg leč iz standarda EN 13503, se lahko klinično ovrednoti s sklicevanjem na standard EN 540.

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2006
• Withdrawal Date: 02-Sep-2014
• 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: 03-Sep-2014
• Ref Project: SIST EN ISO 11979-7:2006 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)

Relations

• Replaces: EN 13503-7:2001 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2001, modified)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11979-7:2014 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
• Effective Date: 06-Mar-2010
• Amended By: EN ISO 11979-7:2006/A1:2012 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations - Amendment 1 (ISO 11979-7:2006/Amd 1:2012)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-7:2006
01-julij-2006
1DGRPHãþD
SIST EN 13503-7:2002
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO.OLQLþQHUD]LVNDYH,62

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-7:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11979-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS 11.040.70 Supersedes EN 13503-7:2001
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2006) Klinische Prüfungen (ISO 11979-7:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2006: E
worldwide for CEN national Members.

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EN ISO 11979-7:2006 (E)





Foreword


This document (EN ISO 11979-7:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with 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 November 2006, and conflicting national
standards shall be withdrawn at the latest by November 2006.

This document supersedes EN 13503-7:2001.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.


Endorsement notice

The text of ISO 11979-7:2006 has been approved by CEN as EN ISO 11979-7:2006 without any
modifications.

2

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INTERNATIONAL ISO
STANDARD 11979-7
Second edition
2006-05-01

Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques




Reference number
ISO 11979-7:2006(E)
©
ISO 2006

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ISO 11979-7:2006(E)
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