EN ISO 11979-7:2024
(Main)Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
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 11979-7:2024)
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 11979-7:2024)
Le présent document spécifie les exigences particulières applicables aux investigations cliniques de lentilles intraoculaires destinées à être implantées dans l’œil pour corriger l’aphakie.
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave intraokularnih leč za korekcijo afakije (ISO 11979-7:2024)
Ta dokument določa posebne zahteve za klinične raziskave intraokularnih leč, ki se vstavijo v oko za korekcijo afakije.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 11979-7:2018
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave
intraokularnih leč za korekcijo afakije (ISO 11979-7:2024)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular
lenses for the correction of aphakia (ISO 11979-7:2024)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen von
Intraokularlinsen für die Korrektion von Aphakie (ISO 11979-7:2024)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de
lentilles intraoculaires pour la correction de l'aphakie (ISO 11979-7:2024)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2024
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
January 2024
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-7:2018
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations of intraocular lenses for the correction of
aphakia (ISO 11979-7:2024)
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 11979-7:2024)
11979-7:2024)
This European Standard was approved by CEN on 19 January 2024.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11979-7:2024) 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 2024, and conflicting national standards shall be
withdrawn at the latest by July 2024.
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 11979-7:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11979-7:2024 has been approved by CEN as EN ISO 11979-7:2024 without any
modification.
International
Standard
ISO 11979-7
Fifth edition
Ophthalmic implants — Intraocular
2024-01
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 11979-7:2024(en) © ISO 2024
ISO 11979-7:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 11979-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and 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 .3
6.2.1 Requirements for all types of IOL .3
6.2.2 Additional requirements for toric IOLs (TIOL).3
6.2.3 Additional requirements for Simultaneous Vision IOL (SVIOL) including MIOL,
EDF and FVR lenses .3
6.2.4 Additional requirements for accommodating IOLs (AIOL) .4
6.2.5 Additional requirements for anterior chamber IOLs .5
6.3 Characteristics of clinical investigations .5
6.3.1 General .5
6.3.2 Characteristics to be studied for all types of IOL .5
6.3.3 Additional characteristics to be studied for toric IOL .6
6.3.4 Additional characteristics to be studied for SVIOLs .6
6.3.5 Additional characteristics to be studied for accommodating IOL.6
6.3.6 Additional characteristics applying to anterior chamber IOLs .6
6.3.7 Additional characteristics . . .6
6.4 Duration of the investigations .7
6.5 Enrolment .7
6.6 Bilateral implantation .7
6.7 Surgical technique .8
6.8 Examination and treatment of subjects .8
6.9 Adverse events reports .8
6.10 Inclusion and exclusion criteria .8
6.10.1 General .8
6.10.2 General inclusion criteria .8
6.10.3 Additional inclusion criteria for toric IOL .8
6.10.4 General exclusion criteria .9
6.10.5 Additional exclusion criteria for simultaneous vision IOL .9
6.10.6 Additional exclusion criteria for anterior chamber IOL .9
Annex A (normative) General elements in the clinical investigation of IOLs .11
Annex B (informative) Additional elements for the clinical investigation of toric IOLs .16
Annex C (informative) Additional elements for the clinical investigation of simultaneous vision
(SVIOL) IOLs .21
Annex D (informative) Additional elements for the clinical investigation of accommodating IOLs .29
Annex E (informative) Evaluation of post operative adverse events and visual acuity rates .34
Annex F (informative) Clinical tests .38
Annex G (informative) Statisti
...
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