EN ISO 11979-7:2018
(Main)Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
ISO 11979-7:2018 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2018
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SIST EN ISO 11979-7:2014
SIST EN ISO 11979-9:2006
SIST EN ISO 11979-9:2006/A1:2014
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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 the United Kingdom.
Endorsement notice
The text of ISO 11979-7:2018 has been approved by CEN as EN ISO 11979-7:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 11979-7
Fourth edition
2018-03
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations of intraocular
lenses for the correction of aphakia
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques de lentilles intraoculaires pour la
correction de l'aphakie
Reference number
ISO 11979-7:2018(E)
©
ISO 2018
ISO 11979-7:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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ii © ISO 2018 – All rights reserved
ISO 11979-7:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 1
4 Justification for a clinical investigation . 2
5 Ethical considerations . 2
6 General requirements . 2
6.1 General . 2
6.2 Design of a clinical investigation . 2
6.2.1 Requirements for all types of IOLs . 2
6.2.2 Additional requirements for toric IOLs (TIOLs) . 3
6.2.3 Additional requirements for multifocal IOLs (MIOLs) . 3
6.2.4 Additional requirements for accommodating IOLs (AIOLs) . 3
6.2.5 Additional requirements for anterior chamber IOLs . 3
6.3 Characteristics of clinical investigations . 4
6.3.1 General. 4
6.3.2 Characteristics to be studied for all types of IOLs . 4
6.3.3 Additional characteristics to be studied for TIOLs . 4
6.3.4 Additional characteristics to be studied for MIOLs . 5
6.3.5 Additional characteristics to be studied for AIOLs . . 5
6.3.6 Additional characteristics applying to anterior chamber IOLs . 5
6.3.7 Additional characteristics . 5
6.4 Duration of the investigations . 5
6.5 Enrolment . 6
6.6 Bilateral implantation . 6
6.7 Surgical technique . 6
6.8 Examination and treatment of subjects. 6
6.9 Adverse events reports . 7
6.10 Inclusion and exclusion criteria . 7
6.10.1 General. 7
6.10.2 Additional inclusion criteria for TIOLs . 7
6.10.3 Additional exclusion criteria for MIOLs . 7
6.10.4 Additional exclusion criteria for anterior chamber IOLs . 8
Annex A (informative) General elements in the clinical investigation of IOLs .9
Annex B (informative) Additional elements for the clinical investigation of TIOLs.14
Annex C (informative) Additional elements for the clinical investigation of multifocal IOLs .19
Annex D (informative) Additional elements in the clinical investigation of accommodating IOLs .22
Annex E (informative) Evaluation of post-operative adverse events and visual acuity rates.27
Annex F (informative) Clinical tests .31
Annex G (informative) Statistical methods and sample size calculations .37
Bibliography .42
ISO 11979-7:2018(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.
The procedures used to develop this docu
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