SIST EN ISO 11979-7:2006/A1:2012

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations - Amendment 1 (ISO 11979-7:2006/Amd 1:2012)

This part of EN 13503 specifies particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
NOTE: Any other type of IOL not directly covered by EN 13503 and any IOL for which the sponsor wishes to investigate claims in addition to those defined in EN 13503 may be clinically evaluated by reference to EN 540.

Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen - Änderung 1 (ISO 11979-7:2006/Amd 1:2012)

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques - Amendement 1 (ISO 11979-7:2006/Amd 1:2012)

Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave - Dopolnilo 1 (ISO 11979-7:2006/Amd 1:2012)

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• Status: Withdrawn
• Public Enquiry End Date: 19-May-2011
• Publication Date: 12-Mar-2012
• Withdrawal Date: 08-Oct-2014
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 09-Oct-2014
• Due Date: 01-Nov-2014
• Completion Date: 09-Oct-2014
• Ref Project: EN ISO 11979-7:2006/A1:2012 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations - Amendment 1 (ISO 11979-7:2006/Amd 1:2012)

Relations

• Amends: SIST EN ISO 11979-7:2006 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
• Effective Date: 01-Apr-2012
• Replaced By: SIST EN ISO 11979-7:2014 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
• Effective Date: 01-Nov-2014
• Amends: SIST EN ISO 11979-7:2006 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-7:2006/A1:2012
01-april-2012
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO.OLQLþQHUD]LVNDYH
'RSROQLOR,62$PG
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations - Amendment 1
(ISO 11979-7:2006/Amd 1:2012)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen - Änderung 1
(ISO 11979-7:2006/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques -
Amendement 1 (ISO 11979-7:2006/Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2006/A1:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-7:2006/A1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-7:2006/A1:2012

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SIST EN ISO 11979-7:2006/A1:2012


EUROPEAN STANDARD
EN ISO 11979-7:2006/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
January 2012
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations - Amendment 1 (ISO 11979-7:2006/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques - Amendement 1 (ISO 11979- Klinische Prüfungen - Änderung 1 (ISO 11979-7:2006/Amd
7:2006/Amd 1:2012) 1:2012)
This amendment A1 modifies the European Standard EN ISO 11979-7:2006; it was approved by CEN on 24 January 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, 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 11979-7:2006/A1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11979-7:2006/A1:2012
EN ISO 11979-7:2006/A1:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11979-7:2006/A1:2012
EN ISO 11979-7:2006/A1:2012 (E)
Foreword
This document (EN ISO 11979-7:2006/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 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 2012, and conflicting national standards shall be withdrawn at the
latest by July 2012.
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 organizations of the following
countries are bound to implement this European Standard: 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, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-7:2006/Amd 1:2012 has been approved by CEN as a EN ISO 11979-7:2006/A1:2012
without any modification.

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SIST EN ISO 11979-7:2006/A1:2012
INTERNATIONAL ISO
STANDARD 11979-7
Second edition
2006-05-01
AMENDMENT 1
2012-01-15
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
AMENDMENT 1
Implants ophtalmiques — Lentilles intraoculaires — Partie 7:
Investigations cliniques
AMENDEMENT 1
Reference number
ISO 11979-7:2006/Amd.1:2012(E)
©
ISO 2012

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SIST EN ISO 11979-7:2006/A1:2012
ISO 11979-7:2006/Amd.1:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 11979-7:2006/A1:2012
ISO 11979-7:2006/Amd.1:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to ISO 11979-7:2006 was prepared by Technical Committee ISO/TC 172, Optics and photonics,
Subcommittee SC 7, Ophthalmic optics and instruments.
© ISO 2012 – All rights reserved iii

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SIST EN ISO 11979-7:2006/A1:2012

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