EN ISO 11979-10:2018
(Main)Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.
There are three main categories of phakic intraocular lenses depending on the optical design:
a) Phakic monofocal (PIOL);
b) Phakic multifocal (PMIOL); and
c) Phakic toric (PTIOL).
Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.
The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.
ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Prüfungen von Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO 11979-10:2018)
Dieses Dokument legt Anforderungen für Intraokularlinsen fest, die zur Implantation in den Vorderabschnitt des Auges vorgesehen sind mit der primären Indikation, dessen Brechkraft zu modifizieren.
Es gibt drei Hauptkategorien für phake Intraokularlinsen in Abhängigkeit von der Ausführung der Optik:
a) phak monofokal (PIOL);
b) phak multifokal (PMIOL); und
c) phak torisch (PTIOL).
Jede dieser Kategorien ist zur Implantation in die vordere oder hintere Augenkammer des vorderen Augenabschnitts vorgesehen.
Die grundlegenden Anforderungen für phake IOL gelten für alle Typen. Zusätzliche Anforderungen gelten für die Ausführungen PMIOL und PTIOL.
Dieses Dokument legt spezifische klinische Anforderungen für phake IOL fest, die nicht bereits in anderen Teilen von ISO 11979 abgedeckt werden.
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Investigations cliniques de lentilles intraoculaires pour la correction de l'amétropie des yeux phaques (ISO 11979-10:2018)
L'ISO 11979-10:2018 spécifie des exigences s'appliquant aux lentilles intraoculaires destinées à être implantées dans le segment antérieur de l'?il, l'indication principale de cela étant de modifier sa puissance de réfraction.
Les lentilles intraoculaires phaques se répartissent en trois grandes catégories, selon leur conception optique:
a) lentilles intraoculaires phaques monofocales (LIOP);
b) lentilles intraoculaires phaques multifocales (LIOPM);
c) lentilles intraoculaires phaques toriques (LIOPT).
En outre, chacune de ces catégories est conçue pour l'implantation dans la chambre antérieure ou dans la chambre postérieure du segment antérieur de l'?il.
Les exigences de base liées aux LIO phaques s'appliquent à tous ces types. Des exigences supplémentaires s'appliquent aux conceptions LIOPM et LIOPT.
L'ISO 11979-10:2018 couvre les exigences cliniques spécifiques aux LIO phaques qui ne sont pas abordées dans les autres parties de l'ISO 11979.
Očesni vsadki (implantati) - Intraokularne leče - 10. del: Klinične preiskave intraokularnih leč za popravek ametropije pri lečah »phakic« (ISO 11979-10:2018)
Ta dokument določa zahteve za vse intraokularne leče, ki so namenjene vsaditvi v notranji
del očesa z glavnim namenom spremeniti lomnost očesa.
Obstajajo tri glavne kategorije intraokularnih leč »phakic« glede na optično zasnovo:
a) monofokalne leče »phakic« (PIOL);
b) multifokalne leče »phakic« (PMIOL); in
c) torične leče »phakic« (PTIOL).
Vsaka od teh kategorij je nadalje namenjena vsaditvi bodisi v sprednji ali zadajšnji
prekat ali notranji del očesa.
Osnovne zahteve za leče »phakic« IOL veljajo za vse vrste leč. Dodatne zahteve veljajo za zasnovi PMIOL in
PTIOL.
Ta dokument obravnava posebne klinične zahteve za leče »phakic« IOL, ki niso obravnavane v
drugih delih standarda ISO 11979.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
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SIST EN ISO 11979-10:2006
SIST EN ISO 11979-10:2006/A1:2014
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Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular
lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Prüfungen von
Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO 11979-10:2018)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Investigations cliniques de
lentilles intraoculaires pour la correction de l'amétropie des yeux phaques (ISO 11979-
10:2018)
Ta slovenski standard je istoveten z: EN ISO 11979-10:2018
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11979-10
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-10:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 10: Clinical
investigations of intraocular lenses for correction of
ametropia in phakic eyes (ISO 11979-10:2018)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 10:
Partie 10: Investigations cliniques de lentilles Klinische Prüfungen von Intraokularlinsen zur
intraoculaires pour la correction de l'amétropie des Korrektion der Ametrophie in phaken Augen (ISO
yeux phaques (ISO 11979-10:2018) 11979-10:2018)
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 11979-10:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11979-10:2018) 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 11979-10:2006.
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 11979-10:2018 has been approved by CEN as EN ISO 11979-10:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 11979-10
Second edition
2018-03
Ophthalmic implants — Intraocular
lenses —
Part 10:
Clinical investigations of intraocular
lenses for correction of ametropia in
phakic eyes
Implants ophtalmiques — Lentilles intraoculaires —
Partie 10: Investigations cliniques de lentilles intraoculaires pour la
correction de l'amétropie des yeux phaques
Reference number
ISO 11979-10:2018(E)
©
ISO 2018
ISO 11979-10:2018(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 11979-10:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
3.1 Terms and definitions . 2
3.2 Abbreviated terms . 2
4 Optical requirements . 2
5 Mechanical requirements . 2
6 Biocompatibility requirements . 2
7 Shelf-life and transport stability requirements . 2
8 Fundamental requirements . 2
9 Justification for a clinical investigation . 3
10 General clinical requirements . 3
10.1 General . 3
10.2 Design of a clinical investigation . 3
10.2.1 Requirements for all types of phakic IOLs . 3
10.2.2 Additional requirements for PTIOLs . 3
10.2.3 Additional requirements for PMIOLs . 4
10.3 Characteristics . 4
10.3.1 General. 4
10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs . 4
10.3.3 Additional characteristics applying to PTIOLs . 5
10.3.4 Additional characteristics applying to PMIOLs . 5
10.4 Duration of the investigation . 5
10.5 Enrolment . 5
10.6 Bilateral implantation . 5
10.7 Surgical technique . 6
10.8 Examination and treatment of subjects. 6
10.9 Adverse events reports . 6
10.10 Inclusion and exclusion criteria . 6
10.10.1 General criteria for all phakic IOLs . 6
10.10.2 Additional criteria for PTIOLs . 9
10.10.3 Additional criteria for multifocal IOLs . 9
11 Information supplied by the manufacturer . 9
Annex A (informative) Elements in a phakic IOL clinical investigation .10
Annex B (informative) Statistical methods and sample size calculations .16
Bibliography .17
ISO 11979-10:2018(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 document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn
...
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