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)

This document specifies the particular requirements for the clinical investigations of intraocular lenses
that are implanted in the eye in order to correct aphakia.

Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2018)

Dieses Dokument legt die besonderen Anforderungen an die klinische Prüfung von Intraokularlinsen (IOL) fest, die zur Korrektur von Aphakie in das Auge implantiert werden.

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2018)

L'ISO 11979-7:2018 spécifie les exigences particulières applicables aux investigations cliniques de lentilles intraoculaires destinées à être implantées dans l'?il pour corriger l'aphakie.

Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave intraokularnih leč za korekcijo afakije (ISO 11979-7:2018)

Ta dokument določa posebne zahteve za klinične preiskave intraokularnih leč,
ki se vstavijo v oko za korekcijo afakije.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 04-May-2017
• Publication Date: 11-Jun-2018
• Withdrawal Date: 08-Feb-2024
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Feb-2024
• Due Date: 28-Feb-2024
• Completion Date: 09-Feb-2024
• Ref Project: 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)

Relations

• Replaces: SIST EN ISO 11979-7:2014 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 11979-7:2014 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
• Effective Date: 01-Jul-2018
• Replaces: SIST EN ISO 11979-9:2006 - Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006)
• Effective Date: 01-Jul-2018
• Replaces: SIST EN ISO 11979-9:2006/A1:2014 - Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006/Amd 1:2014)
• Effective Date: 01-Jul-2018
• Replaced By: SIST EN ISO 11979-7:2024 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
• Effective Date: 01-Mar-2024

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-7:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 11979-7:2014
SIST EN ISO 11979-9:2006
SIST EN ISO 11979-9:2006/A1:2014
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO.OLQLþQHUD]LVNDYH
LQWUDRNXODUQLKOHþ]DNRUHNFLMRDIDNLMH,62
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular
lenses for the correction of aphakia (ISO 11979-7:2018)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von
Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2018)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de
lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2018)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2018
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-7:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-7:2018

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SIST EN ISO 11979-7:2018


EN ISO 11979-7
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-7:2014, EN ISO 11979-
9:2006
English Version

Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations of intraocular lenses for the correction of
aphakia (ISO 11979-7:2018)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Partie 7: Investigations cliniques de lentilles Klinische Prüfungen von Intraokularlinsen für die
intraoculaires pour la correction de l'aphakie (ISO Korrektion von Aphakie (ISO 11979-7:2018)
11979-7:2018)
This European Standard was approved by CEN on 28 February 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11979-7:2018
EN ISO 11979-7:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11979-7:2018
EN ISO 11979-7:2018 (E)
European foreword
This document (EN ISO 11979-7:2018) 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 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 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11979-7:2014 and EN ISO 11979-9:2006.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and t
...